Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by...
Transcript of Angiotensin-II- receptor antagonists (sartans) containing a … · List of medicines affected by...
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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
31 January 2019 EMA/662763/2018 Human Medicines Evaluation Division
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for olmesartan-containing medicinal products
Referral under Article 31 of Directive 2001/83/EC for angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
Procedure number: EMEA/H/A-31/1471
List of medicines affected by the referral procedure EMA/662763/2018 Page 2/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Menarini International Operations Luxembourg S.A.
Amelior Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Amelior Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Amelior Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Amelior® Plus Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 3/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Menarini International Operations Luxembourg S.A.
Amelior® Plus Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Mencord Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Mencord Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Mencord Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Mencord Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Mencord Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria Menarini International Operations Luxembourg S.A.
Mencord Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 4/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Menarini International Operations Luxembourg S.A.
Mencord Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan Sandoz Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan Sandoz Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan/Amlodipin Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan/Amlodipin Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan/Amlodipin Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 5/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Sandoz Gmbh Olmesartan/Hct Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Olmesarcomp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Olmesarcomp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Olmesarcomp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Olmesarcomp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Olmesartan Genericon Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Olmesartan Genericon Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Olmesartan Genericon Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria Arcana Arzneimittel Gmbh
Olmesartanmedoxomil/Amlodipin Mylan
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Arcana Arzneimittel Gmbh
Olmesartanmedoxomil/Amlodipin Mylan
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Austria Arcana Arzneimittel Gmbh
Olmesartanmedoxomil/Amlodipin Mylan
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 6/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Daiichi Sankyo Austria Gmbh
Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 7/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Daiichi Sankyo Austria Gmbh
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 8/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Daiichi Sankyo Austria Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria Daiichi Sankyo Austria Gmbh
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf.
Olmesartan/Hct Actavis Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf.
Olmesartan/Hct Actavis Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf.
Olmesartan/Hct Actavis Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 9/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Actavis Group Ptc Ehf.
Olmesartan/Hct Actavis Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 5mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazid Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazid Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazid Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazid Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartan/Amlodipin Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartan/Amlodipin Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 10/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Accord Healthcare Limited
Olmesartan/Amlodipin Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartanmedoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartanmedoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Accord Healthcare Limited
Olmesartanmedoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Olmeblo Olmesartan Medoxomil 5mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 11/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria G.L. Pharma Gmbh Olmeblo Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Amlocor Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Amlocor Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Amlocor Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan/Amlodipin 1a Pharma
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan/Amlodipin 1a Pharma
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan/Amlodipin 1a Pharma
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 12/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria 1a Pharma Gmbh Olmesartan/Hct 1a Pharma Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan 1a Pharma Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan 1a Pharma Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Olmesartan 1a Pharma Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan/Amlodipin Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan/Amlodipin Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan/Amlodipin Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 13/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Teva B.V Olmesartan/Hct Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan/Hct Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan/Hct Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan/Hct Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan/Hct Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan/Amlodipin Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 14/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Austria Krka, D.D., Novo Mesto
Olmesartan/Amlodipin Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto
Olmesartan/Amlodipin Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 15/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 16/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 17/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 18/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 19/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 20/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V.
Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V.
Co-Olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 21/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Aurobindo Pharma B.V.
Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V.
Co‐olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V.
Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V.
Co-Olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V.
Co‐olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V.
Co-Olmesartan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Hcs Bvba Olmesartan/Amlodipine Hcs Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Hcs Bvba Olmesartan/Amlodipine Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Hcs Bvba Olmesartan/Amlodipine Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 22/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 23/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan Plus Hct Eg Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 24/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Amlodipine 10mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Amlodipine 10mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Amlodipine 10mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Amlodipine 5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Amlodipine 5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Amlodipine 5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan Teva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan Teva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan Teva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 25/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Olmesartan/Amlodipine Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 26/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 27/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 28/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 29/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 30/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmesartan/Amlodipine Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 31/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Olmesartan/Amlodipin Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Olmesartan/Amlodipine Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Olmesartan/Amlodipine Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Olmesartan Sandoz Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Olmesartan Sandoz Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 32/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Sandoz N.V. Co-Olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Co-Olmesartan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Co-Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan/Hctz Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 33/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Belgium Krka, D.D., Novo Mesto
Olmesartan/Hctz Krka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan/Hctz Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan/Hctz Krka Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Belgium Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 34/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Нст Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Теспадан Нст Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Тенсар Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Menarini International Operations Luxembourg S.A.
Тенсар Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 35/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Bulgaria Menarini International Operations Luxembourg S.A.
Тенсар Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva Pharmaceuticals Bulgaria Eood
Олместа Плюс Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva Pharmaceuticals Bulgaria Eood
Олместа Плюс Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva Pharmaceuticals Bulgaria Eood
Олместа Плюс Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva Pharmaceuticals Bulgaria Eood
Олместа Плюс Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Mc Pharma Ad Неосара Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Mc Pharma Ad Неосара Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Mc Pharma Ad Неосара-Ко Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Mc Pharma Ad Неосара-Ко Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 36/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Bulgaria Mylan Eood Олмесартан/Hctz Майлан Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 13mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Mylan Eood Олмесартан/Hctz Майлан Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Spm Bulgaria Ood Олмезид Am Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Spm Bulgaria Ood Олмезид Am Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Spm Bulgaria Ood Олмезид Am Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Olsart Olmesartan Medoxomil 10mg Tablet
Film Coated Tablet Oral Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Olsart Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Olsart Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Коолсарт Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Коолсарт Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 37/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Коолсарт Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Коолсарт Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Accord Healthcare Limited
Олмесартан Медоксомил/Амлодипин Акорд
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Accord Healthcare Limited
Олмесартан Медоксомил/Амлодипин Акорд
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Stada Arzneimittel Ag
Олмезид Плюс Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Stada Arzneimittel Ag
Олмезид Плюс Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Generics [uk] Limited Олмедипин Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 38/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Bulgaria Generics [uk] Limited Олмедипин Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva B.V Олместа А Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva B.V Олместа А Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva B.V Олместа Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Teva B.V Олместа Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Aurobindo Pharma (Malta) Limited
Олмесартан/ Хидрохлоротиазид Ауробиндо
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Aurobindo Pharma (Malta) Limited
Олмесартан/ Хидрохлоротиазид Ауробиндо
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Aurobindo Pharma (Malta) Limited
Олмесартан/ Хидрохлоротиазид Ауробиндо
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Aurobindo Pharma (Malta) Limited
Олмесартан/ Хидрохлоротиазид Ауробиндо
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Tansidor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Tansidor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 39/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Bulgaria Sandoz Pharmaceuticals D.D.
Tansidor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Танзидор Дуо Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Танзидор Дуо Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Танзидор Дуо Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Танзидор Н Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Танзидор Н Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Ко-Олиместра Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Ко-Олиместра Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Ко-Олиместра Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Ко-Олиместра Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 40/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Bulgaria Krka, D.D., Novo Mesto
Олмита Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Олмита Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Олмита Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Олиместра Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Олиместра Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto
Олиместра Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Croatia Genericon Pharma Gesellschaft M.B.H.
Olmesartan Genericon Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Croatia Genericon Pharma Gesellschaft M.B.H.
Olmesartan Genericon Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Croatia Genericon Pharma Gesellschaft M.B.H.
Olmesartan Genericon Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Croatia Genericon Pharma Gesellschaft M.B.H.
Olmesartan/Hidroklorotiazid Genericon
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Croatia Genericon Pharma Gesellschaft M.B.H.
Olmesartan/Hidroklorotiazid Genericon
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Croatia Genericon Pharma Gesellschaft M.B.H.
Olmesartan/Hidroklorotiazid Genericon
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 41/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Croatia Genericon Pharma Gesellschaft M.B.H.
Olmesartan/Hidroklorotiazid Genericon
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 42/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Cyprus Menarini International Operations Luxembourg S.A.
Olartan-Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Olartan-Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 43/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Olartan Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Cyprus Menarini International Operations Luxembourg S.A.
Olartan Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 44/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Cyprus Menarini International Operations Luxembourg S.A.
Olartan Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Cyprus Sanofi-Aventis Cyprus Ltd
Olmesartan+hct Zentiva Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Sanofi-Aventis Cyprus Ltd
Olmesartan+hct Zentiva Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Cyprus Sanofi-Aventis Cyprus Ltd
Olmesartan+hct Zentiva Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Sanofi-Aventis Cyprus Ltd
Olmesartan+hct Zentiva Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Cyprus Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Cyprus Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Cyprus Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 45/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Cyprus Tad Pharma Gmbh Olmesartan/Hydrochlorothiazide Tad
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sarten Plus H Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sarten Plus H Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 46/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Combi Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sintonyn Combi Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sarten Plus H Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 47/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Czech Republic Menarini International Operations Luxembourg S.A.
Sarten Plus H Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sarten Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sarten Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Menarini International Operations Luxembourg S.A.
Sarten Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Apotex Europe B.V. Olmesartan Apotex Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Apotex Europe B.V. Olmesartan Apotex Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Apotex Europe B.V. Olmesartan Apotex Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Zeota Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Zeota Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 48/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Czech Republic Zentiva, K.S. Zeota Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Zeota Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Olmesartan/Amlodipin Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Olmesartan/Amlodipin Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Zentiva, K.S. Olmesartan/Amlodipin Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olimesta Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olimesta Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 49/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Czech Republic Krka, D.D., Novo Mesto
Olimesta Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto
Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 50/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Denmark Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 51/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Denmark Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Benetor Comp. Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Benetor Comp. Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Denmark Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 52/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Denmark Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Denmark Jubilant Pharmaceuticals Nv
Olmesartan Jubilant Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Denmark Jubilant Pharmaceuticals Nv
Olmesartan Jubilant Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Denmark Jubilant Pharmaceuticals Nv
Olmesartan Jubilant Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Olimesta Combi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Olimesta Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Olimesta Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 53/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Denmark Krka Sverige Ab Olimesta Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 54/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Denmark Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Denmark Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Combidiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Combidiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 55/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Denmark Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmedie Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmedie Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmedie Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 56/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Denmark Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 57/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 58/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Estonia Apotex Europe B.V. Olmesartan Medoxomil Apotex
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Apotex Europe B.V. Olmesartan Medoxomil Apotex
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Apotex Europe B.V. Olmesartan Medoxomil Apotex
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 59/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Apotex Europe B.V. Olmesartan Medoxomil/Hydrochlorothiazide Apotex
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Genericon Pharma Gesellschaft M.B.H.
Olmesartan Medoxomil/Hct Genericon
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Genericon Pharma Gesellschaft M.B.H.
Olmesartan Medoxomil/Hct Genericon
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Genericon Pharma Gesellschaft M.B.H.
Olmesartan Medoxomil/Hct Genericon
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Genericon Pharma Gesellschaft M.B.H.
Olmesartan Medoxomil/Hct Genericon
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil Alembic
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil Alembic
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil Alembic
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil/Hydrochlorothiazide Alembic
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 60/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil/Hydrochlorothiazide Alembic
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil/Hydrochlorothiazide Alembic
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil/Hydrochlorothiazide Alembic
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Estonia Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 61/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Estonia Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Estonia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet
Film-Coated Tablet Oral Use
Estonia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Estonia Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil/Amlodipine Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil/Amlodipine Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 62/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil/Amlodipine Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Medoxomil Doc Generici
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Medoxomil Doc Generici
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Medoxomil Doc Generici
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 63/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film Coated Tablet Oral Use
Estonia Doc Generici S.R.L. Olmesartan Hct Sigillata Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 64/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Estonia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 65/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Finland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 66/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 67/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 68/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Sandoz A/S Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Finland Sandoz A/S Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Finland Sandoz A/S Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 69/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Finland Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Stada Arzneimittel Ag
Olmesartan Medoxomil Stada
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 70/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Finland Stada Arzneimittel Ag
Olmesartan Medoxomil Stada
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Finland Stada Arzneimittel Ag
Olmesartan Medoxomil Stada
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Finland Stada Arzneimittel Ag
Olmestad Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Stada Arzneimittel Ag
Olmestad Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 71/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Finland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Finland Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Amlodipine Krka
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Amlodipine Krka
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Amlodipine Krka
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Finland Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 72/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
France Menarini International Operations Luxembourg S.A.
Alteisduo Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Alteisduo Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Axeler Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.944mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Axeler Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.888mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Axeler Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.944mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Alteisduo Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Alteisduo Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 73/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
France Menarini International Operations Luxembourg S.A.
Alteis Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Alteis Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
France Menarini International Operations Luxembourg S.A.
Alteis Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.944mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.888mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.944mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 74/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 75/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
France Daiichi Sankyo France Sas
Coolmetec Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
France Daiichi Sankyo France Sas
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 76/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Olmesartan Medoxomil Zydus
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Menarini International Operations Luxembourg S.A.
Vocado Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Menarini International Operations Luxembourg S.A.
Vocado Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Menarini International Operations Luxembourg S.A.
Vocado Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Menarini International Operations Luxembourg S.A.
Vocado Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 77/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Menarini International Operations Luxembourg S.A.
Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Menarini International Operations Luxembourg S.A.
Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Menarini International Operations Luxembourg S.A.
Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Menarini International Operations Luxembourg S.A.
Vocado Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Substipharm Developpement
Miradizan Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Substipharm Developpement
Miradizan Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Substipharm Developpement
Miradizan Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Astron Research Limited
Olmesartanmedoxomil/Amlodipin Astron
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Astron Research Limited
Olmesartanmedoxomil/Amlodipin Astron
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 78/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Astron Research Limited
Olmesartanmedoxomil/Amlodipin Astron
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Berlin-Chemie Ag Votum Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Berlin-Chemie Ag Votum Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Berlin-Chemie Ag Votum Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Berlin-Chemie Ag Votum Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan Al Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan Al Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan Al Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 79/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Aliud Pharma Gmbh Olmesartan/Amlodipin Al Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan/Amlodipin Al Amlodipine 10mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan/Amlodipin Al Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Olmesartan/Hydrochlorothiazid Al
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Olmesartan Abz Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Olmesartan Abz Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Olmesartan Abz Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Olmesartan/Amlodipin Abz Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 80/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Abz-Pharma Gmbh Olmesartan/Amlodipin Abz Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Olmesartan/Amlodipin Abz Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmedipin Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 12.5mg Tablet, Olmesartan 20mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 25mg Tablet, Olmesartan 20mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 81/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Ratiopharm Gmbh Olmesartan Abz Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan-Rtp Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmeamlo Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmeamlo Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmeamlo Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 82/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Tad Pharma Gmbh Olmecor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmecor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmecor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Olmecor Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Zentiva Pharma Gmbh
Olmesartan Amlodipin Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Germany Zentiva Pharma Gmbh
Olmesartan Amlodipin Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet
Film-Coated Tablet Oral Use
Germany Zentiva Pharma Gmbh
Olmesartan Amlodipin Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 83/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Hexal Ag Olmesartan Plus Amlodipin Hexal
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Plus Amlodipin
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Plus Amlodipin
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Olmesartan Hexal Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 84/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany 1 A Pharma Gmbh Olmesartan/Amlodipin Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan/Amlodipin Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan/Amlodipin Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan 1 A Pharma Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan 1 A Pharma Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan 1 A Pharma Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Olmesartan Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 85/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Betapharm Arzneimittel Gmbh
Olmesartanmedoxomil Amlodipin Beta
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Betapharm Arzneimittel Gmbh
Olmesartanmedoxomil Amlodipin Beta
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Betapharm Arzneimittel Gmbh
Olmesartanmedoxomil Amlodipin Beta
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Glenmark Pharmaceuticals Europe Limited
Olmesartan Glenmark Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Glenmark Pharmaceuticals Europe Limited
Olmesartan Glenmark Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Glenmark Pharmaceuticals Europe Limited
Olmesartan Glenmark Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Olmesartan Heumann Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Olmesartan Heumann Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Olmesartan Heumann Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Olmesartan/Hydrochlorothiazid Heumann
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 86/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Heumann Pharma Gmbh & Co. Generica Kg
Olmesartan/Hydrochlorothiazid Heumann
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Olmesartan/Hydrochlorothiazid Heumann
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Olmesartan/Hydrochlorothiazid Heumann
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Alembic Pharmaceuticals Europe Ltd
Olmesartanmedoxomil Alembic
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Alembic Pharmaceuticals Europe Ltd
Olmesartanmedoxomil Alembic
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Alembic Pharmaceuticals Europe Ltd
Olmesartanmedoxomil Alembic
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Accord Healthcare Limited
Olmesartanmedoxomil/Amlodipin Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Accord Healthcare Limited
Olmesartanmedoxomil/Amlodipin Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Accord Healthcare Limited
Olmesartanmedoxomil/Amlodipin Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 87/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Hetero Europe S.L. Olmesartan Hetero Europe S.L.
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Hetero Europe S.L. Olmesartan Hetero Europe S.L.
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Hetero Europe S.L. Olmesartan Hetero Europe S.L.
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Aurobindo Pharma Gmbh
Olmesartan/Hydrochlorothiazid Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Aurobindo Pharma Gmbh
Olmesartan/Hydrochlorothiazid Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Aurobindo Pharma Gmbh
Olmesartan/Hydrochlorothiazid Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Aurobindo Pharma Gmbh
Olmesartan/Hydrochlorothiazid Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Olmesartanmedoxomil Mylan
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Olmesartanmedoxomil Mylan
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 88/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Mylan Dura Gmbh Olmesartanmedoxomil/Amlodipin Mylan
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Olmesartanmedoxomil/Amlodipin Mylan
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Olmesartanmedoxomil/Amlodipin Mylan
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Olmesartanmedoxomil Mylan
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Macleods Pharma Uk Ltd
Olmesartan Medoxomillhydroehlorthiazid Macleods
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Macleods Pharma Uk Ltd
Olmesartan Medoxomil/Hydrochlorthiazid Macleods
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Macleods Pharma Uk Ltd
Olmesartan Medoxomil/Hydrochlorthiazid Macleods
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Macleods Pharma Uk Ltd
Olmesartan Medoxomillhydrochlorthiazid Macleods
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Macleods Pharma Uk Ltd
Olmesartan Medoxomil Macleods
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Macleods Pharma Uk Ltd
Olmesartan Medoxomil Macleods
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Macleods Pharma Uk Ltd
Olmesartan Medoxomil Macleods
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 89/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan/Amlodipin/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 90/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 91/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Daiichi Sankyo Europe Gmbh
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmes Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmes Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmesartan Daiichi Sankyo Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 92/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmes Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmes Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmes Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmes Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmes Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Germany Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 93/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Germany Krka, D.D., Novo Mesto
Olmeamlo Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Orizal Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Orizal Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 94/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Greece Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Orizal Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Olartan-Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Οlartan Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Οlartan Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Greece Menarini International Operations Luxembourg S.A.
Οlartan Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 95/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Greece Mylan S.A.S Olmesartan Mylan Olmesartan 10mg Tablet Film-Coated Tablet Oral Use
Greece Mylan S.A.S Olmesartan Mylan Olmesartan 20mg Tablet Film-Coated Tablet Oral Use
Greece Mylan S.A.S Olmesartan Mylan Olmesartan 30mg Tablet Film-Coated Tablet Oral Use
Greece Pharmaserve-Lilly Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmaserve-Lilly Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmaserve-Lilly Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmaserve-Lilly Olmetec Plus® Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmaserve-Lilly Olmetec Plus® Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmaserve-Lilly Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmaserve-Lilly Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 96/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Pfizer Hellas, A.E. Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Pfizer Hellas, A.E. Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Greece Pfizer Hellas, A.E. Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Greece Pfizer Hellas, A.E. Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 97/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Olmesartan+hydrochlorothiazide Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Olmesartan Zentiva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral
Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral
List of medicines affected by the referral procedure EMA/662763/2018 Page 98/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral
Greece Norma Hellas S.A. Co-Ipertas Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral
Greece Norma Hellas S.A. Ipertas Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral
Greece Norma Hellas S.A. Ipertas Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral
Greece Norma Hellas S.A. Ipertas Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral
Greece Generics Pharma Hellas Ltd
Olmesartan + Hctz Mylan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Generics Pharma Hellas Ltd
Olmesartan + Hctz Mylan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Generics Pharma Hellas Ltd
Olmesartan + Hctz Mylan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Generics Pharma Hellas Ltd
Olmesartan + Hctz Mylan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 99/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Greece Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Greece Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan + Amlodipine Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan + Amlodipine Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan + Amlodipine Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan+hctz Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan+hctz Sandoz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan+hctz Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan+hctz Sandoz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan Sandoz Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Greece Sandoz Pharmaceuticals D.D.
Olmesartan Sandoz Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 100/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Greece Sandoz Pharmaceuticals D.D.
Olmesartan Sandoz Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Duactan Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Duactan Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Duactan Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Duactan Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 101/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Hungary Menarini International Operations Luxembourg S.A.
Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Duactan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Laresin Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Laresin Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Hungary Menarini International Operations Luxembourg S.A.
Laresin Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 102/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Hungary Berlin-Chemie Ag Laresin Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt
Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt
Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt
Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 103/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Hungary Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Olmiza Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Olmiza Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto
Olmiza Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 104/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Iceland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 105/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Iceland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 106/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Sevikar Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 107/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Iceland Daiichi Sankyo Europe Gmbh
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Iceland Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Konverge Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 108/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 109/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Omesar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Omesar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Menarini International Operations Luxembourg S.A.
Omesar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 110/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Olmesartan Hydrochlorothiazide Rowex
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Olmesartan Rowex Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Olmesartan Rowex Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Olmesartan Rowex Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf.
Olmesartan Hydrochlorothiaizde Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf.
Olmesartan Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 111/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Actavis Group Ptc Ehf.
Olmesartan Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf.
Olmesartan Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf.
Olmesartan Actavis Olmesartan Medoxomil 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Sevikar Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 112/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Daiichi Sankyo Ireland Limited
Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Sevikar Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Benetor Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Benetor Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Benetor Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 113/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Daiichi Sankyo Ireland Limited
Benetor Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Benetor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Benetor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Daiichi Sankyo Ireland Limited
Benetor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 114/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord Healthcare
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil Accord Healthcare
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil Accord Healthcare
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Accord Healthcare Limited
Olmesartan Medoxomil Accord Healthcare
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Stada Arzneimittel Ag
Olmesartan/Hydrochlorothiazide Stada Arzneimittel Ag
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Stada Arzneimittel Ag
Olmesartan/Hydrochlorothiazide Stada Arzneimittel Ag
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Stada Arzneimittel Ag
Olmesartan/Hydrochlorothiazide Film-Coated Tablets
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Stada Arzneimittel Ag
Olmesartan/Hydrochlorothiazide Stada Arzneimittel Ag
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Generics [uk] Limited Olmesartan Medoxomil Generics [uk]
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Generics [uk] Limited Olmesartan Medoxomil Generics [uk]
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Generics [uk] Limited Olmesartan Medoxomil Generics [uk]
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 115/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Teva Pharma B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Mcdermott Laboratories Ltd
Olmesartan /Amlodipine Mylan
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Mcdermott Laboratories Ltd
Olmesartan /Amlodipine Mylan
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Mcdermott Laboratories Ltd
Olmesartan /Amlodipine Mylan
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan Medoxomil Clonmel
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan Medoxomil Clonmel
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan Medoxomil Clonmel
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan/Amlodipine Clonmel
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan/Amlodipine Clonmel
Amlodipine 10mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan/Amlodipine Clonmel
Amlodipine 5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan/Hydrochlorothiazide Clonmel
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan/Hydrochlorothiazide Clonmel
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 116/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Clonmel Healthcare Ltd.
Olmesartan/Hydrochlorothiazide Clonmel
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd.
Olmesartan/Hydrochlorothiazide Clonmel
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan/Amlodipine Krka Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan/Hydrochlorothiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan/Hydrochlorothiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan/Hydrochlorothiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan/Hydrochlorothiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 117/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Ireland Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Bivis Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Bivis Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Bivis Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Giant Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Giant Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 118/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Menarini International Operations Luxembourg S.A.
Giant Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Olprezide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Olprezide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Plaunazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Plaunazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Olpress Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Olpress Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 119/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Menarini International Operations Luxembourg S.A.
Olpress Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Olprezide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Olprezide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Plaunac Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Plaunac Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Plaunac Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Menarini International Operations Luxembourg S.A.
Plaunazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 120/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Menarini International Operations Luxembourg S.A.
Plaunazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Substipharm Developpement
Pieralzan Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Substipharm Developpement
Pieralzan Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Substipharm Developpement
Pieralzan Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan E Idroclorotiazide Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan Medoxomil E Amlodipina Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan Medoxomil E Amlodipina Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 121/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Zentiva Italia Srl Olmesartan Medoxomil E Amlodipina Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan Medoxomil Zentiva
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan Medoxomil Zentiva
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Olmesartan Medoxomil Zentiva
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Vi.Rel Pharma Sas Olmesartan Vi.Rel Pharma Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Vi.Rel Pharma Sas Olmesartan Vi.Rel Pharma Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 122/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Hcs Bvba Olmesartan Medoxomil E Idroclorotiazide Hcs
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Hcs Bvba Olmesartan Hcs Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan Medoxomil E Amlodipina Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan Medoxomil E Amlodipina Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan Medoxomil E Amlodipina Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 123/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Olmesartan E Idroclorotiazide Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Olmesartan Medoxomil E Idroclorotiazide Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 124/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 125/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Idroclorotiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 126/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 127/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil E Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 128/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Teva B.V Olmesartan Medoxomil E Amlodipina Teva
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Teva B.V Olmesartan Medoxomil E Amlodipina Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Teva B.V Olmesartan Medoxomil E Amlodipina Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Olmedie Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Olmedie Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Olmedie Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Presdiur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Presdiur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 129/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Laboratorio Farmaceutico Ct Srl
Presdiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Presdiur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 130/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 131/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 132/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy I.B.N. Savio S.R.L. Idalazide Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Idalman Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L.
Olmesartan Medoxomil E Idroclorotiazide Alter
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L.
Olmesartan Medoxomil E Idroclorotiazide Alter
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L.
Olmesartan Medoxomil E Idroclorotiazide Alter
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 133/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Laboratori Alter S.R.L.
Olmesartan Medoxomil E Idroclorotiazide Alter
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L.
Olmesartan Medoxomil Alter Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L.
Olmesartan Medoxomil Alter Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L.
Olmesartan Medoxomil Alter Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Olmesartan E Idroclorotiazide Tecnigen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Olmesartan Tecnigen Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Olmesartan Tecnigen Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Olmesartan Tecnigen Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 134/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Pensa Pharma S.P.A. Olmesartan Medoxomil Pensa
Olmesartan Medoxomil 10mg Tablet
Film Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Olmesartan Medoxomil Pensa
Olmesartan Medoxomil 20mg Tablet
Film Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Olmesartan Medoxomil Pensa
Olmesartan Medoxomil 40mg Tablet
Film Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 135/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 136/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 137/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 138/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 139/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 140/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan Medoxomil E Idroclorotiazide Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 141/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 142/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 143/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 144/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 145/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 146/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 147/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Sevitrex Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan E Amlodipina Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan E Amlodipina Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan E Amlodipina Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan E Amlodipina Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan E Amlodipina Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmesartan E Amlodipina Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 148/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 149/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 150/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmegan Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 151/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Daiichi Sankyo Italia S.P.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Olmesartan E Idroclorotiazide Eg
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 152/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Olmesartan Medoxomil Eg Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan Medoxomil Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 153/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 154/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 155/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 156/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 157/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Olmesartan E Idroclorotiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 158/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Doc Generici S.R.L. Olmesartan Doc Generici Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan Doc Generici Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan Doc Generici Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Amlodipina Doc
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 159/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Olmesartan E Idroclorotiazide Doc
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Olmesartan E Idroclorotiazide Mylan
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Olmesartan E Idroclorotiazide Mylan
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Olmesartan Medoxomil E Idroclorotiazide Mylan
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 13mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Olmesartan Medoxomil E Idroclorotiazide Mylan
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Olmesartan Medoxomil Mylan
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 160/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Italy Mylan S.P.A. Olmesartan Medoxomil Mylan
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Olmesartan Medoxomil Mylan
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Olmesartan Medoxomil Mylan
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto
Olmesartan E Amlodipina Krka
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto
Olmesartan E Amlodipina Krka
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto
Olmesartan E Amlodipina Krka
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 161/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 162/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Latvia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Latvia Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Latvia Hcs Bvba Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 163/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Latvia Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Latvia Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Latvia Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Zentiva, K.S. Osaver Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Latvia Zentiva, K.S. Osaver Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 164/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Latvia Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Latvia Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Latvia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Latvia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet
Film-Coated Tablet Oral Use
Latvia Zentiva, K.S. Olmesartan Medoxomil/Amlodipine Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Latvia Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil/Amlodipine Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil/Amlodipine Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Latvia Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil/Amlodipine Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil/Amlodipine Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 165/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Latvia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 166/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 167/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Sanoral Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Mesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 168/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Menarini International Operations Luxembourg S.A.
Mesar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 169/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil Actavis
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 170/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 171/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 172/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Actavis Group Ptc Ehf.
Olmesartan Medoxomil/Hydrochlorothiazide Actavis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 173/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 174/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 175/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 176/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 177/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Teva B.V Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zentiva, K.S. Osaver Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 178/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Zentiva, K.S. Osaver Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 179/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 180/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 181/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 182/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 183/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 184/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmepur Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil /Amlodipine Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil /Amlodipine Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 185/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil /Amlodipine Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil /Amlodipine Sandoz Pharmaceuticals D.D.
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Olmira Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Olmira Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Olmira Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 186/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Lithuania Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 187/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Forzaten/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Belsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 188/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Luxembourg Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Menarini International Operations Luxembourg S.A.
Belsar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Olmesartan Comp Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 189/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Luxembourg Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Olmesartan Ratiopharm Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan Eg Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan Plus Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan Plus Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan Plus Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan Plus Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 190/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Luxembourg Eurogenerics N.V./S.A.
Olmesartan/Amlodipine Eg Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar/Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 191/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Luxembourg Daiichi Sankyo Belgium S.A
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Daiichi Sankyo Belgium S.A
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Konverge Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 192/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Malta Menarini International Operations Luxembourg S.A.
Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Konverge Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Konverge Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 193/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Malta Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Omesar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Omesar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Omesar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Malta Menarini International Operations Luxembourg S.A.
Omesar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 194/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Malta Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 5mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf.
Vivactra Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf.
Vivactra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf.
Vivactra Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf.
Vivactra Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf.
Vivactra Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Aurobindo Pharma (Malta) Limited
Olmesartan Aurobindo Pharma (Malta)
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Malta Aurobindo Pharma (Malta) Limited
Olmesartan Aurobindo Pharma (Malta)
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Malta Aurobindo Pharma (Malta) Limited
Olmesartan Aurobindo Pharma (Malta)
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 195/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Malta Aurobindo Pharma (Malta) Limited
Olmesartan/Hydrochlorothiazide Aurobindo Pharma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Malta Aurobindo Pharma (Malta) Limited
Olmesartan/Hydrochlorothiazide Aurobindo Pharma (Malta)
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Aurobindo Pharma (Malta) Limited
Olmesartan/Hydrochlorothiazide Aurobindo Pharma (Malta)
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Malta Aurobindo Pharma (Malta) Limited
Olmesartan/Hydrochlorothiazide Aurobindo Pharma (Malta)
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 196/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Menarini International Operations Luxembourg S.A.
Belfor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Apotex Europe B.V. Olmesartan Medoxomil Apotex
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Apotex Europe B.V. Olmesartan Medoxomil Apotex
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Apotex Europe B.V. Olmesartan Medoxomil Apotex
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 197/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V.
Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V.
Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V.
Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V.
Olmesartanmedoxomil/Hydrochloorthiazide Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V.
Olmesartanmedoxomil Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V.
Olmesartanmedoxomil Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V.
Olmesartanmedoxomil Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Olmesartan Medoxomil Mylan
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 198/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Mylan B.V. Olmesartan Medoxomil Mylan
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Olmesartan Medoxomil Mylan
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Ratiopharm Gmbh Olmesartan Medoxomil/Amlodipine Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Ratiopharm Gmbh Olmesartan Medoxomil/Amlodipine Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Ratiopharm Gmbh Olmesartan Medoxomil/Amlodipine Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 199/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 200/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmesartan Medoxomil/Amlodipine/Hct Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmetec Hctz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmetec Hctz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmetec Hctz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 201/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Daiichi Sankyo Nederland B.V.
Olmetec Hctz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Nederland B.V.
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 202/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Centrafarm B.V. Olmesartan Medoxomil/Hct Cf
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Olmesartanmedoxomil Cf Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Olmesartanmedoxomil Cf Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Olmesartanmedoxomil Cf Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil Alembic
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil Alembic
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Alembic Pharmaceuticals Europe Ltd
Olmesartan Medoxomil Alembic
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochloorthiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochloorthiazide Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochloorthiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 203/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochloorthiazide Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartanmedoxomil/Amlodipine Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartanmedoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartanmedoxomil/Amlodipine Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Stada Arzneimittel Ag
Olmesartanmedoxomil/Amlodipine Stada
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Stada Arzneimittel Ag
Olmesartanmedoxomil/Amlodipine Stada
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Stada Arzneimittel Ag
Olmesartanmedoxomil/Amlodipine Stada
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Amlodipine Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 204/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil/Hct Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Olmesartan Medoxomil Teva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Olmesartan Medoxomil Sandoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 205/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Olmesartanmedoxomil/Hydrochloorthiazide Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 206/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Daiichi Sankyo Europe Gmbh
Capenon Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochloorthiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochloorthiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochloorthiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochloorthiazide Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 207/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Norway Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Alea Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 208/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Norway Menarini International Operations Luxembourg S.A.
Alea Comp Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Benetor Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Norway Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 209/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Norway Menarini International Operations Luxembourg S.A.
Benetor Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Norway Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Norway Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Norway Accord Healthcare Limited
Olmesartan Medoxomil Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Olmetec Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Olmetec Comp Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Olmetec Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 210/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Norway Daiichi Sankyo Europe Gmbh
Olmetec Comp Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Norway Daiichi Sankyo Europe Gmbh
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Norway Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Norway Krka, D.D., Novo Mesto
Olmesartan Medoxomil/Hydrochlorothiazide Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Norway Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Norway Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Norway Krka, D.D., Novo Mesto
Olmesartan Medoxomil Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Elestar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 211/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Poland Menarini International Operations Luxembourg S.A.
Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Elestar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Elestar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Elestar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Elestar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 212/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Poland Menarini International Operations Luxembourg S.A.
Revival Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Revival Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Revival Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Revival Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Poland Menarini International Operations Luxembourg S.A.
Revival Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 213/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Zentiva, K.S. Osaver Hct Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Zentiva, K.S. Osaver Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Poland Zentiva, K.S. Osaver Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Poland Zentiva, K.S. Osaver Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmetiaz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmetiaz Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmetiaz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 214/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Polmetiaz Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 215/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Poland Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Olsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Olsar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 216/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Zolnor Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Olsar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Olsar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Olsar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 217/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Menarini International Operations Luxembourg S.A.
Olsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Menarini International Operations Luxembourg S.A.
Olsar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Olmesartan Medoxomilo + Hidroclorotiazida Substipharm
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Olmesartan Medoxomilo + Hidroclorotiazida Substipharm
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 218/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Substipharm Developpement
Olmesartan Medoxomilo + Hidroclorotiazida Substipharm
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Olmesartan Medoxomilo + Hidroclorotiazida Substipharm
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Olmesartan Medoxomilo Substipharm
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Olmesartan Medoxomilo Substipharm
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Olmesartan Medoxomilo Substipharm
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Sathenar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Sathenar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Substipharm Developpement
Sathenar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Lumec
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Lumec
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Lumec
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 219/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Lumec
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo Lumec
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo Lumec
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo Lumec
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Tolife
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Tolife
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Tolife
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Tolife
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo Tolife
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo Tolife
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Olmesartan Medoxomilo Tolife
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 220/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Tolife - Produtos Farmacêuticos, S.A.
Amlodipina + Olmesartan Medoxomilo Tolife
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Amlodipina + Olmesartan Medoxomilo Tolife
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Amlodipina + Olmesartan Medoxomilo Tolife
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Pharmakern
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 221/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Olmesartan Medoxomilo Pharmakern
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Olmesartan Medoxomilo Pharmakern
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Olmesartan Medoxomilo Pharmakern
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 222/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Amlodipina + Olmesartan Medoxomilo Cinfa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Olmesartan Medoxomilo + Hidroclorotiazida Cinfa
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 13mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Amlodipina + Olmesartan Medoxomilo Mylan
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 223/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Olmesartan Medoxomilo + Hidroclorotiazida Mylan
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Olmesartan Medoxomilo Mylan
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Olmesartan Medoxomilo Mylan
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Olmesartan Medoxomilo Mylan
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Amlodipina + Olmesartan Medoxomilo Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Amlodipina + Olmesartan Medoxomilo Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Amlodipina + Olmesartan Medoxomilo Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida 1apharma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 224/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida 1apharma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida 1apharma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida 1apharma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida 1apharma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan + Hidroclorotiazida Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 225/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz Farmaceutica Lda.
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz Farmacêutica
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz Farmaceutica Lda.
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz Farmacêutica
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda.
Olmesartan Medoxomilo Sandoz Farmacêutica
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo Teva
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo Teva
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo Teva
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo Teva
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 226/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Ciclum Farma Unipessoal Lda.
Amlodipina + Olmesartan Medoxomilo Ciclum
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Amlodipina + Olmesartan Medoxomilo Ciclum
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Amlodipina + Olmesartan Medoxomilo Ciclum
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Amlodipina + Olmesartan Medoxomilo Ciclum
Amlodipine 5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Ciclum
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Ciclum
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Ciclum
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Ciclum
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Olmesartan Medoxomilo Ciclum
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Olmesartan Medoxomilo Ciclum
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda.
Olmesartan Medoxomilo Ciclum
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 227/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Sanofi - Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Olmesartan Medoxomilo Zentiva
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Olmesartan Medoxomilo Zentiva
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Olmesartan Medoxomilo Zentiva
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Amlodipina + Olmesartan Medoxomilo Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Amlodipina + Olmesartan Medoxomilo Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Amlodipina + Olmesartan Medoxomilo Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 228/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Atolme
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo + Hidroclorotiazida Alter
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo Atolme
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 229/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Alter, S.A. Olmesartan Medoxomilo Atolme
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo Atolme
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo Alter
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo Alter
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Olmesartan Medoxomilo Alter
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Amlodipina + Olmesartan Medoxomilo Alter
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Amlodipina + Olmesartan Medoxomilo Alter
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Amlodipina + Olmesartan Medoxomilo Alter
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 230/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Azevedos
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Tad Pharma Gmbh Amlodipina + Olmesartan Medoxomilo Tad
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Tad Pharma Gmbh Amlodipina + Olmesartan Medoxomilo Tad
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Tad Pharma Gmbh Amlodipina + Olmesartan Medoxomilo Tad
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 231/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo + Hidroclorotiazida Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo Daiichi Sankyo
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Amlodipina + Olmesartan Medoxomilo Daiichi Sankyo
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 232/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 233/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 234/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Daiichi Sankyo Portugal, Unip. Lda
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 235/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan + Hidroclorotiazida Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan + Hidroclorotiazida Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan + Hidroclorotiazida Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan + Hidroclorotiazida Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Teva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Teva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 236/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo Teva
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Olmesartan Medoxomilo Teva
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan + Hctz Deka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan + Hctz Deka Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan + Hctz Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 237/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan + Hidroclorotiazida Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan + Hidroclorotiazida Zidrium Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan + Hidroclorotiazida Zidrium
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan + Hidroclorotiazida Zidrium 40 Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Amlodipina Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Amlodipina Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Amlodipina Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 238/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm
Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo + Hidroclorotiazida Ratiopharm
Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo Ratiopharm
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomil Ratiopharm
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo Ratiopharm
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomil Ratiopharm
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomilo Ratiopharm
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 239/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomil Ratiopharm
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Olmesartan Medoxomil Ratiopharm
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 240/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo Pentafarma
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 241/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 242/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Pentafarma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 243/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo Farmoz
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 244/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Farmoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 245/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Labesfal
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Labesfal
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Labesfal
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Phar - Promoção De Medicamentos, Unip. Lda.
Olmesartan Medoxomilo + Hidroclorotiazida Labesfal
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 246/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 247/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 248/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 249/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurobindo
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 250/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 251/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 252/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 253/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 254/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 255/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 256/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 257/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 258/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Aurovitas
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 259/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis Phar
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 260/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo + Hidroclorotiazida Generis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis Phar
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis Phar
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis Phar
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis Phar
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis Phar
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis Phar
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A.
Olmesartan Medoxomilo Generis Phar
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva B.V Olmesartan Medoxomilo + Amlodipina Teva
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva B.V Olmesartan Medoxomilo + Amlodipina Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva B.V Olmesartan Medoxomilo + Amlodipina Teva
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 261/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.
Amlodipina + Olmesartan Medoxomilo Bluepharma
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.
Amlodipina + Olmesartan Medoxomilo Bluepharma
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.
Amlodipina + Olmesartan Medoxomilo Bluepharma
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Distriquímica, S.A. Olmesartan Medoxomilo Distriquimica
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Distriquímica, S.A. Olmesartan Medoxomilo Distriquimica
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Olmesartan Hetero Europe S.L.
Olmesartan 10mg Tablet Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Olmesartan Hetero Europe S.L.
Olmesartan 20mg Tablet Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Olmesartan Hetero Europe S.L.
Olmesartan 40mg Tablet Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Amlodipina + Olmesartan Medoxomilo Krka
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Amlodipina + Olmesartan Medoxomilo Krka
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 262/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Portugal Krka, D.D., Novo Mesto
Amlodipina + Olmesartan Medoxomilo Krka
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Olmesartan Medoxomilo + Hidroclorotiazida Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Olmesartan Medoxomilo + Hidroclorotiazida Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Olmesartan Medoxomilo + Hidroclorotiazida Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Olmesartan Medoxomilo + Hidroclorotiazida Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Olmesartan Medoxomilo Krka
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Olmesartan Medoxomilo Krka
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto
Olmesartan Medoxomilo Krka
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Romania Menarini International Operations Luxembourg S.A.
Inovum Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 263/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Menarini International Operations Luxembourg S.A.
Inovum Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Menarini International Operations Luxembourg S.A.
Inovum Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Menarini International Operations Luxembourg S.A.
Inovum Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Romania Menarini International Operations Luxembourg S.A.
Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Romania Menarini International Operations Luxembourg S.A.
Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Menarini International Operations Luxembourg S.A.
Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Romania Menarini International Operations Luxembourg S.A.
Inovum Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 264/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Berlin-Chemie Ag Santini Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Romania Berlin-Chemie Ag Santini Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Romania Berlin-Chemie Ag Santini Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Romania Hcs Bvba Olssa Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Hcs Bvba Olssa Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 265/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 266/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 267/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5μg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Malta Operations (Row) Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 268/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipina Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipina Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 269/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 270/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 271/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipină Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania S.C. Sandoz S.R.L. Olmesartan Medoxomil/Amlodipină Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania S.C. Sandoz S.R.L. Olmesartan Medoxomil/Amlodipină Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Romania S.C. Sandoz S.R.L. Olmesartan Medoxomil/Amlodipină Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 272/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet
Film-Coated Tablet Oral Use
Romania Zentiva, K.S. Olmesartan Medoxomil/Amlodipină Zentiva
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 273/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Romania Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 274/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Folgan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Tenzar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 275/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Slovakia Menarini International Operations Luxembourg S.A.
Tenzar Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Tenzar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Tenzar Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Tenzar Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Tenzar Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Slovakia Menarini International Operations Luxembourg S.A.
Tenzar Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Slovakia Stada Arzneimittel Ag
Olmestad Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 276/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Slovakia Stada Arzneimittel Ag
Olmestad Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Slovakia Stada Arzneimittel Ag
Olmestad Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 277/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Slovakia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Co-Tensiol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Co-Tensiol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 278/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Olectan Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Co-Tensiol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Co-Tensiol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Tensiol Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 279/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Slovenia Menarini International Operations Luxembourg S.A.
Tensiol Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Slovenia Menarini International Operations Luxembourg S.A.
Tensiol Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Slovenia Sandoz Pharmaceuticals D.D.
Medoksomilolmesartanat/Amlodipin Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Sandoz Pharmaceuticals D.D.
Medoksomilolmesartanat/Amlodipin Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Slovenia Sandoz Pharmaceuticals D.D.
Medoksomilolmesartanat/Amlodipin Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 280/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Slovenia Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12500μg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmicombi Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olmita Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto
Olimestra Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Balzak Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Balzak Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 281/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Menarini International Operations Luxembourg S.A.
Balzak Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Balzak Plus Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Balzak Plus Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Ixia Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 282/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Menarini International Operations Luxembourg S.A.
Ixia Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Ixia Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Ixia Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Ixia Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Ixia Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Menarini International Operations Luxembourg S.A.
Ixia Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Astron Research Limited
Olmesartan Medoxomil/Amlodipine Astron
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 283/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Astron Research Limited
Olmesartan Medoxomil/Amlodipine Astron
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Astron Research Limited
Olmesartan Medoxomil/Amlodipine Astron
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Nasdo Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Nasdo Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Nasdo Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Spi Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Spi Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Spi Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Swanpond Investments
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Swanpond Investments
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan Swanpond Investments
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan/Hidroclorotiazida Nasdo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 284/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Swan Pond Investments Limited
Olmesartan/Hidroclorotiazida Nasdo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan/Hidroclorotiazida Nasdo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Swan Pond Investments Limited
Olmesartan/Hidroclorotiazida Nasdo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex
Hydrochlorothiazide 25mg Tablet, Olmesartan 20mg Tablet
Tablet Oral
Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex
Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet
Tablet Oral
Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex
Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet
Tablet Oral
Spain Apotex Europe B.V. Olmesartán Apotex Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Apotex Europe B.V. Olmesartán Apotex Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Apotex Europe B.V. Olmesartán Apotex Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Apotex Europe B.V. Olmesartán/Hidroclorotiazida Apotex
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 285/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Macleods Pharma España, S.L.U
Olmesartan Medoxomil Macleods Pharma España, S.L.U.
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Macleods Pharma España, S.L.U
Olmesartan Medoxomil Macleods Pharma España, S.L.U.
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Macleods Pharma España, S.L.U
Olmesartan Medoxomil Macleods Pharma España, S.L.U.
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Olmesartán Qualigen Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Olmesartán Qualigen Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Olmesartán Qualigen Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Olmesartan/Hidroclorotiazida Qualigen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 286/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Tecnimede España Ind. Fca., S.A.
Olmesartán Tecnigen Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca., S.A.
Olmesartán Tecnigen Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca., S.A.
Olmesartán Tecnigen Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca., S.A.
Olmesartán/Hidroclorotiazida Tecnigen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca., S.A.
Olmesartán/Hidroclorotiazida Tecnigen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca., S.A.
Olmesartán/Hidroclorotiazida Tecnigen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca., S.A.
Olmesartán/Hidroclorotiazida Tecnigen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U.
Olmesartán/Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U.
Olmesartán/Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U.
Olmesartán Aurovitas Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 287/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Aurovitas Spain,s.A.U.
Olmesartán Aurovitas Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U.
Olmesartán Aurovitas Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U.
Olmesartán/Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U.
Olmesartán/Hidroclorotiazida Aurovitas
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 288/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Pfizer, S.L. Capenon Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Capenon Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Capenon Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 289/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Daiichi Sankyo España, S.A.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 290/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Daiichi Sankyo España, S.A.
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Openvas Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Openvas Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo España, S.A.
Openvas Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U.
Olmesartán Combix Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U.
Olmesartán Combix Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U.
Olmesartán Combix Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U.
Olmesartán/Hidroclorotiazida Combix
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U.
Olmesartán/Hidroclorotiazida Combix
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U.
Olmesartán/Hidroclorotiazida Combix
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 291/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Laboratorios Combix, S.L.U.
Olmesartán/Hidroclorotiazida Combix
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Olmesartán/Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Olmesartán/Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Olmesartán/Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Olmesartán/Hidroclorotiazida Aurobindo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Olmesartán Aurobindo Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Olmesartán Aurobindo Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Olmesartán Aurobindo Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán Pensa Pharma Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán Pensa Pharma Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán Pensa Pharma Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 292/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Pensa Pharma, S.A.U.
Olmesartán/Hidroclorotiazida Pensa Pharma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán/Hidroclorotiazida Pensa Pharma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg / 25 Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán/Hidroclorotiazida Pensa Pharma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán/Hidroclorotiazida Pensa Pharma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán/Amlodipino Pensa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán/Amlodipino Pensa
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A.U.
Olmesartán/Amlodipino Pensa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L.
Olmesartan/Hidroclorotiazida Mylan
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L.
Olmesartan/Hidroclorotiazida Mylan
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L.
Olmesartan/Hidroclorotiazida Mylan
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 293/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Mylan Pharmaceuticals S.L.
Olmesartan/Hidroclorotiazida Mylan
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L.
Olmesartán Mylan Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L.
Olmesartán Mylan Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L.
Olmesartán Mylan Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán Sandoz Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán Sandoz Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán Sandoz Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán/Hidroclorotiazida Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán/Hidroclorotiazida Sandoz
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán/Hidroclorotiazida Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán/Hidroclorotiazida Sandoz
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 294/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Aristo Pharma Iberia, S.L.
Olmesartan Hibes Aristo Pharma Iberia
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Aristo Pharma Iberia, S.L.
Olmesartan Hibes Aristo Pharma Iberia
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Aristo Pharma Iberia, S.L.
Olmesartan Hibes Aristo Pharma Iberia
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartan/Amlodipino Ratiopharm
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartan/Amlodipino Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartan/Amlodipino Ratiopharm
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartán Ratiopharm Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartán Ratiopharm Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartán/Hidroclorotiazida Ratio
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartán/Hidroclorotiazida Ratio
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartán/Hidroclorotiazida Ratio
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 295/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Ratiopharm España S.A.,
Olmesartán/Hidroclorotiazida Ratio
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm España S.A.,
Olmesartan Ratiopharm Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen
Hydrochlorothiazide 12.5mg Tablet, Olmesartan 20mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U., Olmesartan Tevagen Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U., Olmesartan Tevagen Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U., Olmesartán Tevagen Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U., Olmesartán/Hidroclorotiazida Tevagen
Hydrochlorothiazide 25mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán/Amlodipino Sandoz
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 296/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Sandoz Farmacéutica, S.A.
Olmesartán/Amlodipino Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 10mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A.
Olmesartán/Amlodipino Sandoz
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 5mg Tablet
Film-Coated Tablet Oral Use
Spain Tedec-Meiji Farma, S.A.
Olmesartán Meiji Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Tedec-Meiji Farma, S.A.
Olmesartán Meiji Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Tedec-Meiji Farma, S.A.
Olmesartán Meiji Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Olmesartan/Hidroclorotiazida Mabo
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Olmesartán Mabo-Farma Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 297/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Mabo-Farma, S.A. Olmesartán Mabo-Farma Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Olmesartán Mabo-Farma Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A.
Olmesartán Cinfa Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral
Spain Laboratorios Cinfa, S.A.
Olmesartán Cinfa Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral
Spain Laboratorios Cinfa, S.A.
Olmesartán Cinfa Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral
Spain Laboratorios Cinfa, S.A.
Olmesartán / Hidroclorotiazida Cinfa
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A.
Olmesartán / Hidroclorotiazida Cinfa
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A.
Olmesartán / Hidroclorotiazida Cinfa
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A.
Olmesartán / Hidroclorotiazida Cinfa
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A.
Olmesartán/Amlodipino Cinfa
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A.
Olmesartán/Amlodipino Cinfa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 298/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Laboratorios Cinfa, S.A.
Olmesartán/Amlodipino Cinfa
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán Stada Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán Stada Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán Stada Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Amlodipino Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Amlodipino Amlodipine 10mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Amlodipino Amlodipine 5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stada
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stada
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stada
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stada
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 299/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stadagen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stadagen
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stadagen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L.
Olmesartán/Hidroclorotiazida Stadagen
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Olmesartán Tarbis Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Olmesartán Tarbis Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Olmesartán Tarbis Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 300/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Tarbis Farma, S.L. Olmesartán/Hidroclorotiazida Tarbis
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Hcs Bvba Olmesartán/Amlodipino Hcs Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Hcs Bvba Olmesartán/Amlodipino Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Hcs Bvba Olmesartán/Amlodipino Hcs Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Tad Pharma Gmbh Olmesartán/Amlodipino Tad Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Tad Pharma Gmbh Olmesartán/Amlodipino Tad Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Tad Pharma Gmbh Olmesartán/Amlodipino Tad Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Glenmark Pharmaceuticals S.R.O.
Olmesartán/Hidroclorotiazida Viso Farmacéutica
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Glenmark Pharmaceuticals S.R.O.
Olmesartán/Hidroclorotiazida Viso Farmacéutica
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Glenmark Pharmaceuticals S.R.O.
Olmesartán/Hidroclorotiazida Viso Farmacéutica
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Glenmark Pharmaceuticals S.R.O.
Olmesartán/Hidroclorotiazida Viso Farmacéutica
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 301/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Industria Química Y Farmaceútica Vir, S.A.
Olmesartán Vir Olmesartan Medoxomil 40mg Tablet
Film Coated Tablet Oral Use
Spain Industria Química Y Farmaceútica Vir, S.A.
Olmesartán Vir Olmesartan Medoxomil 20mg Tablet
Film Coated Tablet Oral Use
Spain Industria Química Y Farmaceútica Vir, S.A.
Olmesartán Vir Olmesartan Medoxomil 10mg Tablet
Film Coated Tablet Oral Use
Spain Industria Química Y Farmaceútica Vir, S.A.
Olmesartán / Hidroclorotiazida Vir
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Industria Química Y Farmaceútica Vir, S.A.
Olmesartán / Hidroclorotiazida Vir
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Industria Química Y Farmaceútica Vir, S.A.
Olmesartán / Hidroclorotiazida Vir
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Industria Química Y Farmaceútica Vir, S.A.
Olmesartán / Hidroclorotiazida Vir
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Glenmark Pharmaceuticals Europe Limited
Olmesartán Viso Farmacéutica
Olmesartan Medoxomil 10mg Tablet
Coated Tablet Oral Use
Spain Glenmark Pharmaceuticals Europe Limited
Olmesartán Viso Farmacéutica
Olmesartan Medoxomil 20mg Tablet
Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 302/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Glenmark Pharmaceuticals Europe Limited
Olmesartán Viso Farmacéutica
Olmesartan Medoxomil 40mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Atolme Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Atolme Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Atolme Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Atolme Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartan/Hidroclorotiazida Alter
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartan/Hidroclorotiazida Alter
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartan/Hidroclorotiazida Alter
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartan/Hidroclorotiazida Alter
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 303/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Laboratorios Alter, S.A.
Atolme Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Atolme Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Atolme Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartán Alter Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartán Alter Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartán Alter Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Albis Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Albis Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Albis Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartán/Amlodipino Alter Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartán/Amlodipino Alter Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A.
Olmesartán/Amlodipino Alter Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 304/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartan/Hidroclorotiazida Kern Pharma
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartán Kern Pharma Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartán Kern Pharma Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartán Kern Pharma Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartán/Amlodipino Kern Pharma
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartán/Amlodipino Kern Pharma
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Olmesartán/Amlodipino Kern Pharma
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Gobens
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Normon
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 305/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Normon
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Gobens
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Gobens
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Gobens
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Normon
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán Normon Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán Normon Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán Normon Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Hidroclorotiazida Normon
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Amlodipino Normon
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 306/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Laboratorios Normon, S.A.
Olmesartán/Amlodipino Normon
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A.
Olmesartán/Amlodipino Normon
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Teva B.V Olmesartan/Amlodipino Teva Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Teva B.V Olmesartan/Amlodipino Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Teva B.V Olmesartan/Amlodipino Teva Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Distriquímica, S.A. Olmesartán Distriquimica Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Distriquímica, S.A. Olmesartán Distriquimica Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Zentiva, K.S. Olmesartán Zentiva Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Zentiva, K.S. Olmesartán Zentiva Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 307/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Zentiva, K.S. Olmesartán/Hidroclorotiazida Zentiva
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Zentiva, K.S. Olmesartán Zentiva Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartán Medoxomilo/Amlodipino Accord
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartán Medoxomilo/Amlodipino Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartán Medoxomilo/Amlodipino Accord
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartan Medoxomilo/Hidroclorotiazida Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartan Medoxomilo/Hidroclorotiazida Accord
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartan Medoxomilo/Hidroclorotiazida Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartan Medoxomilo/Hidroclorotiazida Accord
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 308/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Accord Healthcare S.L.U.
Olmesartan Medoxomilo Accord
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartan Medoxomilo Accord
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U.
Olmesartan Medoxomilo Accord
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo Europe Gmbh
Openvas Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo Europe Gmbh
Openvas Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo Europe Gmbh
Openvas Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Daiichi Sankyo Europe Gmbh
Openvas Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 309/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Spain Krka, D.D., Novo Mesto
Co-Olimestra Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olmesartán Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olmesartán Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olmesartán Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olmesartán/Hidroclorotiazida Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olmesartán/Hidroclorotiazida Krka
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olmesartán/Hidroclorotiazida Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olmesartán/Hidroclorotiazida Krka
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olseron Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olseron Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto
Olseron Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 310/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
Sweden Jubilant Pharmaceuticals Nv
Olmesartan Jubilant Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
Sweden Jubilant Pharmaceuticals Nv
Olmesartan Jubilant Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
Sweden Jubilant Pharmaceuticals Nv
Olmesartan Jubilant Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Substipharm Developpement
Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Substipharm Developpement
Davidol Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Substipharm Developpement
Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Substipharm Developpement
Davidol Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Substipharm Developpement
Olmesartan Medoxomil Substipharm Developpement
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Substipharm Developpement
Olmesartan Medoxomil Substipharm Developpement
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Substipharm Developpement
Olmesartan Medoxomil Substipharm Developpement
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 311/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Milpharm Limited Olmesartan Milpharm Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Milpharm Limited Olmesartan Milpharm Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Milpharm Limited Olmesartan Milpharm Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Jubilant Pharmaceuticals Nv
Olmesartan Medoxomil Jubilant Pharmaceuticals
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva
Hydrochlorothiazide 12.5mg Tablet, Olmesartan 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva
Hydrochlorothiazide 25mg Tablet, Olmesartan 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva
Hydrochlorothiazide 12.5mg Tablet, Olmesartan 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Olmesartan Medoxomil/Hydrochlorothiazide Teva Uk
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Olmesartan Medoxomil Teva Uk
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 312/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Teva Uk Limited Olmesartan Medoxomil Teva Uk
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Olmesartan Medoxomil Teva Uk
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Hct Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 313/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Daiichi Sankyo Uk Ltd
Sevikar Hct Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Olmetec Plus Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Olmetec Plus Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Olmetec Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Olmetec Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Daiichi Sankyo Uk Ltd
Olmetec Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 314/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Glenmark Pharmaceuticals Europe Limited
Olmesartan Medoxomil Glenmark
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Thornton & Ross Ltd Olmesartan/Hydrochlorothiazide Stada
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Thornton & Ross Ltd Olmesartan Stada Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Thornton & Ross Ltd Olmesartan Stada Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Thornton & Ross Ltd Olmesartan Stada Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Winthrop Pharmaceuticals Uk Ltd
Olmesartan Winthrop Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 315/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Winthrop Pharmaceuticals Uk Ltd
Olmesartan Winthrop Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Winthrop Pharmaceuticals Uk Ltd
Olmesartan Winthrop Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Winthrop Pharmaceuticals Uk Ltd
Olmesartan/Amlodipine Winthrop
Olmesartan Medoxomil 20mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Winthrop Pharmaceuticals Uk Ltd
Olmesartan/Amlodipine Winthrop
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 13.89mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Winthrop Pharmaceuticals Uk Ltd
Olmesartan/Amlodipine Winthrop
Olmesartan Medoxomil 40mg Tablet, Amlodipine Besilate 6.95mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Actavis Group Ptc Ehf.
Olmesartan Actavis Group Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Actavis Group Ptc Ehf.
Olmesartan Actavis Group Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Actavis Group Ptc Ehf.
Olmesartan Actavis Group Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 20mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 316/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 12.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil/Hydrochlorothiazide Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Hydrochlorothiazide 25mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil Accord Healthcare
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord Healthcare
Olmesartan Medoxomil 20mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Amlodipine 5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil/Amlodipine Accord Healthcare
Olmesartan Medoxomil 40mg Tablet, Amlodipine 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil Accord Healthcare
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited
Olmesartan Medoxomil Accord Healthcare
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Generics [uk] Limited Olmesartan Medoxomil Generics Uk
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Generics [uk] Limited Olmesartan Medoxomil Generics Uk
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Generics [uk] Limited Olmesartan Medoxomil Generics Uk
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 317/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Torrent Pharma Gmbh
Olmesartan Torrent Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Torrent Pharma Gmbh
Olmesartan Torrent Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Torrent Pharma Gmbh
Olmesartan Torrent Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Distriquímica, S.A. Olmesartan Distriquimica Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Distriquímica, S.A. Olmesartan Distriquimica Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Distriquímica, S.A. Olmesartan Distriquimica Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Crescent Pharma Limited
Olmesartan Medoxomil Crescent Pharma
Olmesartan Medoxomil 10μg Tablet
Film-Coated Tablet Oral Use
United Kingdom Crescent Pharma Limited
Olmesartan Medoxomil Crescent Pharma
Olmesartan Medoxomil 20μg Tablet
Film-Coated Tablet Oral Use
United Kingdom Crescent Pharma Limited
Olmesartan Medoxomil Crescent Pharma
Olmesartan Medoxomil 40μg Tablet
Film-Coated Tablet Oral Use
United Kingdom Macleods Pharma Uk Ltd
Olmesartan Macleods Pharma Uk
Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Macleods Pharma Uk Ltd
Olmesartan Medoxomil Macleods Pharma Uk
Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Macleods Pharma Uk Ltd
Olmesartan Medoxomil Macleods Pharma Uk
Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 10mg Tablet
Film-Coated Tablet Oral Use
List of medicines affected by the referral procedure EMA/662763/2018 Page 318/318
Member State in EEA
Marketing authorisaton holder
Product name INN + Strength Pharmaceutical form Route of administration
United Kingdom Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 20mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Krka, D.D., Novo Mesto
Olmesartan Krka Olmesartan Medoxomil 40mg Tablet
Film-Coated Tablet Oral Use