dexlansoprazole, lansoprazole: List of nationally ... · Lansoprazole Salvat 15 mg comprimés...
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 13 September 2017 EMA/727763/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): dexlansoprazole, lansoprazole Procedure No.: PSUSA/00001827/201612
Transcript of dexlansoprazole, lansoprazole: List of nationally ... · Lansoprazole Salvat 15 mg comprimés...
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
13 September 2017 EMA/727763/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): dexlansoprazole, lansoprazole
Procedure No.: PSUSA/00001827/201612
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EMA/727763/2017 Page 2/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Agopton 15 mg - Kapseln DE/H/1699/001 1-20544 TAKEDA PHARMA GES.M.B.H. AT Agopton 15 mg - Kapseln DE/H/1699/001 1-20544 TAKEDA PHARMA GES.M.B.H. AT Agopton 15 mg Kapseln DE/H/1699/001 36286.01.00 TAKEDA GMBH (KONSTANZ) DE Agopton 15 mg Kapseln DE/H/1699/001 36286.01.00 TAKEDA GMBH (KONSTANZ) DE Agopton 30 mg - Kapseln DE/H/1699/002 1-20545 TAKEDA PHARMA GES.M.B.H. AT Agopton 30 mg - Kapseln DE/H/1699/002 1-20545 TAKEDA PHARMA GES.M.B.H. AT Agopton 30 mg Kapseln DE/H/1699/002 36286.00.00 TAKEDA GMBH (KONSTANZ) DE Agopton 30 mg Kapseln DE/H/1699/002 36286.00.00 TAKEDA GMBH (KONSTANZ) DE Agopton Tabs 15 mg Schmelztabletten DE/H/1699/003 38409.01.00 TAKEDA GMBH (KONSTANZ) DE Agopton Tabs 15 mg Schmelztabletten DE/H/1699/003 38409.01.00 TAKEDA GMBH (KONSTANZ) DE Agopton Tabs 30 mg Schmelztabletten DE/H/1699/004 38409.00.00 TAKEDA GMBH (KONSTANZ) DE Agopton Tabs 30 mg Schmelztabletten DE/H/1699/004 38409.00.00 TAKEDA GMBH (KONSTANZ) DE Dakar 15 mg , Maagsapresistente capsule, hard DE/H/1699/001 BE184107 SANOFI BELGIUM BE Dakar 15 mg , Maagsapresistente capsule, hard DE/H/1699/001 BE184107 SANOFI BELGIUM BE Dakar 15 mg , Maagsapresistente capsule, hard DE/H/1699/001 BE184107 SANOFI BELGIUM BE Dakar 15 mg , Maagsapresistente capsule, hard DE/H/1699/001 BE184107 SANOFI BELGIUM BE Dakar 15 mg gélules gastro-résistants DE/H/1699/001 0240122 SANOFI BELGIUM LU Dakar 15 mg gélules gastro-résistants DE/H/1699/001 0240119 SANOFI BELGIUM LU Dakar 30 mg , Maagsapresistente capsule, hard DE/H/1699/002 NOT APPLICABLE SANOFI BELGIUM BE Dakar 30 mg , Maagsapresistente capsule, hard DE/H/1699/002 BE159695 SANOFI BELGIUM BE Dakar 30 mg , Maagsapresistente capsule, hard DE/H/1699/002 BE159695 SANOFI BELGIUM BE Dakar 30 mg gélules gastro-résistants DE/H/1699/002 BE159695 SANOFI BELGIUM BE Dakar 30 mg gélules gastro-résistants DE/H/1699/002 0231879 SANOFI BELGIUM LU Dakar 30 mg gélules gastro-résistants DE/H/1699/002 0204823 SANOFI BELGIUM LU Dostab Flas 15 mg comprimidos bucodispersables
not available 78395 LABORATORIOS SALVAT, S.A. ES
Dostab Flas 30 mg comprimidos bucodispersables
not available 78396 LABORATORIOS SALVAT, S.A. ES
Duomate Flas 15 mg comprimidos bucodispersables
ES/H/0217/001 77740 LABORATORIOS SALVAT, S.A. ES
Duomate Flas 30 mg comprimidos bucodispersables
ES/H/0217/002 77741 LABORATORIOS SALVAT, S.A. ES
Lansobene 15 mg - Kapseln not available 1-25531 RATIOPHARM ARZNEIMITTEL AT
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Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
VERTRIEBS-GMBH Lansobene 30 mg - Kapseln not available 1-25532 RATIOPHARM ARZNEIMITTEL
VERTRIEBS-GMBH AT
Lansoprazol "Pensa", hårde enterokapsler 15 mg SE/H/1133/001 48831 PENSA PHARMA AB DK Lansoprazol "Pensa", hårde enterokapsler 30 mg SE/H/1133/002 48832 PENSA PHARMA AB DK Lansoprazol AbZ 15 mg magensaftresistente Hartkapseln
DE/H/3931/001 90591.00.00 ABZ-PHARMA GMBH DE
Lansoprazol AbZ 30 mg magensaftresistente Hartkapseln
DE/H/3931/002 90592.00.00 ABZ-PHARMA GMBH DE
Lansoprazol Flas Salvat 15 mg comprimidos bucodispersables
ES/H/0213/001 77.738 LABORATORIOS SALVAT, S.A. ES
Lansoprazol Flas Salvat 30 mg comprimidos bucodispersables
ES/H/0213/002 77.739 LABORATORIOS SALVAT, S.A. ES
Lansoprazol Pensa 15 mg enterokapslar, hårda SE/H/1133/001 28015 PENSA PHARMA AB SE Lansoprazol Pensa 15 mg enterokapsler, harde SE/H/1133/001 13-9506 PENSA PHARMA AB NO Lansoprazol Pensa 15 mg magensaftresistente Hartkapseln
SE/H/1133/001 85022.00.00 PENSA PHARMA GMBH DE
Lansoprazol Pensa 30 mg enterokapslar, hårda SE/H/1133/002 28016 PENSA PHARMA AB SE Lansoprazol Pensa 30 mg enterokapsler, harde SE/H/1133/002 13-9507 PENSA PHARMA AB NO Lansoprazol Pensa 30 mg magensaftresistente Hartkapseln
SE/H/1133/002 85023.00.00 PENSA PHARMA GMBH DE
Lansoprazol Ranbaxy 15 mg munsönderfallande tablett
ES/H/0213/001 48457 RANBAXY UK LTD SE
Lansoprazol Ranbaxy 30 mg munsönderfallande tablett
ES/H/0213/002 48458 RANBAXY UK LTD SE
Lansoprazol Teva 15 mg enterosolventní tvrdé tobolky
DE/H/3899/001/DC
09/045/15-C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
Lansoprazol Teva 15 mg, maagsapresistente capsules, hard
DE/H/3931/001 RVG 114235 TEVA NEDERLAND B.V. NL
Lansoprazol Teva 30 mg, maagsapresistente capsules, hard
DE/H/3931/002 RVG 114236 TEVA NEDERLAND B.V. NL
Lansoprazol Teva 30mg enterosolventní tvrdé tobolky
DE/H/3899/002 09/046/15-C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
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EMA/727763/2017 Page 4/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606850 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606868 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606876 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606900 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606918 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606926 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606850 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606868 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606876 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606900 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606918 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 15 mg Cápsulas gastrorresistentes
not available 5606926 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606942 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606959 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606967 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606975 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5607007 BLUESCIENCE UNIPESSOAL LDA. PT
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Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5607015 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606942 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606959 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606967 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5606975 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5607007 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes
not available 5607015 BLUESCIENCE UNIPESSOAL LDA. PT
Lansoprazole 15 mg Gastro-resistant Capsules not available PA 749/135/01 TEVA PHARMA B.V. IE Lansoprazole 15 mg orodispersible tablets ES/H/0213/001 PL 14894/0728 RANBAXY UK LTD UK Lansoprazole 30 mg Gastro-resistant Capsules not available PA 749/135/02 TEVA PHARMA B.V. IE Lansoprazole 30 mg orodispersible tablets ES/H/0213/002 PL 14894/0729 RANBAXY UK LTD UK Lansoprazole ratiopharm 15 mg enterokapseli, kova
DE-H-3899-001-002
33910 RATIOPHARM GMBH FI
Lansoprazole ratiopharm 15 mg hårda enterokapslar
DE-H-3899-001-002
33910 RATIOPHARM GMBH FI
LANSOPRAZOLE RATIOPHARM 15 mg, gélule gastrorésistante
DE/H/3899/001 2015120201 RATIOPHARM GMBH LU
Lansoprazole ratiopharm 30 mg enterokapseli, kova
DE-H-3899-001-002
33911 RATIOPHARM GMBH FI
Lansoprazole ratiopharm 30 mg hårda enterokapslar
DE-H-3899-001-002
33911 RATIOPHARM GMBH FI
Lansoprazole ratiopharm 30 mg magasýruþolin hörð hylki
DE-H-3899-001-002
IS/1/16/056/02 RATIOPHARM GMBH IS
Lansoprazole Salvat 15 mg comprimés orodispersibles
ES/H/0213/001 6 318 651 1 LABORATORIOS SALVAT, S.A. FR
Lansoprazole Salvat 30 mg comprimés orodispersibles
ES/H/0213/002 6 494 067 2 LABORATORIOS SALVAT, S.A. FR
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Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazole Teva 15 mg gélules gastro-résistantes
DE/H/3899/001 BE467680 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 15 mg gélules gastro-résistantes
DE/H/3899/001 BE467697 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 15 mg magensaftresistente Hartkapseln
DE/H/3899/001 BE467697 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 15 mg magensaftresistente Hartkapseln
DE/H/3899/001 BE467680 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 15 mg, maagsapresistente capsules, hard
DE/H/3899/001 BE467697 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 15 mg, maagsapresistente capsules, hard
DE/H/3899/001 BE467680 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 30 mg gélules gastro-résistantes
DE/H/3899/002 BE467715 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 30 mg gélules gastro-résistantes
DE/H/3899/002 BE467706 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 30 mg magensaftresistente Hartkapseln
DE/H/3899/002 BE467706 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 30 mg magensaftresistente Hartkapseln
DE/H/3899/002 BE467715 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 30 mg, maagsapresistente capsules, hard
DE/H/3899/002 BE467706 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva 30 mg, maagsapresistente capsules, hard
DE/H/3899/002 BE467715 TEVA PHARMA BELGIUM N.V./S.A BE
Lansoprazole Teva Pharma 15 mg Gastro-resistant Capsules, hard
DE/H/3899/001 PA1986/008/001 TEVA B.V IE
Lansoprazole Teva Pharma 30 mg Gastro-resistant Capsules, hard
DE/H/3899/002 PA1986/008/002 TEVA B.V IE
Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili
ES/H/0213/001 042070072 LABORATORI ALTER S.R.L. IT
Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili
ES/H/0213/001 042070033 LABORATORI ALTER S.R.L. IT
Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili
ES/H/0213/001 042070021 LABORATORI ALTER S.R.L. IT
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Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili
ES/H/0213/001 042070019 LABORATORI ALTER S.R.L. IT
Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili
ES/H/0213/002 042070045 LABORATORI ALTER S.R.L. IT
Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili
ES/H/0213/002 042070058 LABORATORI ALTER S.R.L. IT
Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili
ES/H/0213/002 042070060 LABORATORI ALTER S.R.L. IT
Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili
ES/H/0213/002 042070084 LABORATORI ALTER S.R.L. IT
Lansoprazolo TecniGen Italia 15 mg compresse orodispersibili
ES/H/0217/001 042069017 TECNIGEN S.R.L. IT
Lansoprazolo TecniGen Italia 15 mg compresse orodispersibili
ES/H/0217/001 042069029 TECNIGEN S.R.L. IT
Lansoprazolo TecniGen Italia 15 mg compresse orodispersibili
ES/H/0217/001 042069031 TECNIGEN S.R.L. IT
Lansoprazolo TecniGen Italia 30 mg compresse orodispersibili
ES/H/0217/002 042069043 TECNIGEN S.R.L. IT
Lansoprazolo TecniGen Italia 30 mg compresse orodispersibili
ES/H/0217/002 042069056 TECNIGEN S.R.L. IT
Lansoprazolo TecniGen Italia 30 mg compresse orodispersibili
ES/H/0217/002 042069068 TECNIGEN S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056264 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056252 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056249 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056288 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056290 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056276 TEVA ITALIA S.R.L. IT
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EMA/727763/2017 Page 8/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056237 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056201 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056213 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056225 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056112 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056100 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056124 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056314 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056011 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056023 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056187 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056175 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056163 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056136 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056148 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056151 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056098 TEVA ITALIA S.R.L. IT
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Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056086 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056074 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056199 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056326 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056047 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056062 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
DE/H/3899/001 043056050 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 15 mg capsule rigide gastroresistenti
DE/H/3899/001 043056035 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056340 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056353 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056631 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056605 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056617 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056365 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056377 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056389 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056403 TEVA ITALIA S.R.L. IT
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EMA/727763/2017 Page 10/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056427 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056415 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056567 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056466 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056581 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056593 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056579 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056478 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056530 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg capsule rigide gastroresistenti
DE/H/3899/002 043056542 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056555 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056338 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056454 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056480 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056492 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056516 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056504 TEVA ITALIA S.R.L. IT
-
EMA/727763/2017 Page 11/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056391 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056439 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056441 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056643 TEVA ITALIA S.R.L. IT
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti
DE/H/3899/002 043056528 TEVA ITALIA S.R.L. IT
Lansoprazol-ratiopharm® 15 mg magensaftresistente Hartkapseln
DE-H-3899-001-002
90100.00.00 RATIOPHARM GMBH DE
Lansoprazol-ratiopharm® 15 mg magensaftresistente Hartkapseln
DE/H/3899/001 IS/1/16/056/01 RATIOPHARM GMBH IS
Lansoprazol-ratiopharm® 30 mg magensaftresistente Hartkapseln
DE/H/3899/002 90101.00.00 RATIOPHARM GMBH DE
Lansoprazol-ratiopharm® 30 mg magensaftresistente Hartkapseln
DE/H/3899/002 2015120202 RATIOPHARM GMBH LU
Lansox 15 mg capsule rigide DE/H/1699/001 028600029 TAKEDA ITALIA S.P.A. IT Lansox 15 mg capsule rigide DE/H/1699/001 028600031 TAKEDA ITALIA S.P.A. IT Lansox 15 mg capsule rigide DE/H/1699/001 028600043 TAKEDA ITALIA S.P.A. IT Lansox 15 mg capsule rigide DE/H/1699/001 028600029 TAKEDA ITALIA S.P.A. IT Lansox 15 mg capsule rigide DE/H/1699/001 028600031 TAKEDA ITALIA S.P.A. IT Lansox 15 mg capsule rigide DE/H/1699/001 028600043 TAKEDA ITALIA S.P.A. IT Lansox 15 mg compresse orodispersibili DE/H/1699/003 28600070 TAKEDA ITALIA S.P.A. IT Lansox 15 mg compresse orodispersibili DE/H/1699/003 28600082 TAKEDA ITALIA S.P.A. IT Lansox 15 mg compresse orodispersibili DE/H/1699/003 28600070 TAKEDA ITALIA S.P.A. IT Lansox 15 mg compresse orodispersibili DE/H/1699/003 28600082 TAKEDA ITALIA S.P.A. IT Lansox 30 mg capsule rigide DE/H/1699/002 028600017 TAKEDA ITALIA S.P.A. IT Lansox 30 mg capsule rigide DE/H/1699/002 028600056 TAKEDA ITALIA S.P.A. IT Lansox 30 mg capsule rigide DE/H/1699/002 028600068 TAKEDA ITALIA S.P.A. IT Lansox 30 mg capsule rigide DE/H/1699/002 028600017 TAKEDA ITALIA S.P.A. IT Lansox 30 mg capsule rigide DE/H/1699/002 028600056 TAKEDA ITALIA S.P.A. IT
-
EMA/727763/2017 Page 12/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lansox 30 mg capsule rigide DE/H/1699/002 028600068 TAKEDA ITALIA S.P.A. IT Lansox 30 mg compresse orodispersibili DE/H/1699/004 28600094 TAKEDA ITALIA S.P.A. IT Lansox 30 mg compresse orodispersibili DE/H/1699/004 028600106 TAKEDA ITALIA S.P.A. IT Lansox 30 mg compresse orodispersibili DE/H/1699/004 28600094 TAKEDA ITALIA S.P.A. IT Lansox 30 mg compresse orodispersibili DE/H/1699/004 028600106 TAKEDA ITALIA S.P.A. IT Lanzo 15 mg munndreifitöflur IT/H/0226/003 IS/1/02/131/01 PFIZER APS IS Lanzo 15mg, munsönderfallande tabletter IT/H/0226/003 17060 PFIZER AB SE Lanzo 30 mg munndreifitöflur IT/H/0226/004 IS/1/02/131/02 PFIZER APS IS Lanzo 30 mg, munsönderfallande tabletter IT/H/0226/004 17061 PFIZER AB SE Lanzo Melt 15 mg smeltetabletter IT/H/0226/003 01-957 PFIZER AS NO Lanzo Melt 30 mg smeltetabletter IT/H/0226/004 01-958 PFIZER AS NO LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 345 486-5 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 345 490-2 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 358 815-2 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 358 816-9 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 345 487-1 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 345 485-9 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 345 489-4 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 560 860-5 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 345 488-8 SANOFI-AVENTIS FRANCE FR LANZOR 15 MG, GELULE GASTRO-RESISTANTE not available 340 960-0 SANOFI-AVENTIS FRANCE FR LANZOR 30 MG, GELULES GASTRO-RESISTANTES
not available 333 411-5 SANOFI-AVENTIS FRANCE FR
LANZOR 30 MG, GELULES GASTRO-RESISTANTES
not available 558 545-9 SANOFI-AVENTIS FRANCE FR
LANZOR 30 MG, GELULES GASTRO-RESISTANTES
not available 344 756-9 SANOFI-AVENTIS FRANCE FR
LANZOR 30 MG, GELULES GASTRO-RESISTANTES
not available 343 035-6 SANOFI-AVENTIS FRANCE FR
LANZOR 30 MG, GELULES GASTRO-RESISTANTES
not available 344 755-2 SANOFI-AVENTIS FRANCE FR
LANZOR 30 MG, GELULES GASTRO-RESISTANTES
not available 343 033-3 SANOFI-AVENTIS FRANCE FR
-
EMA/727763/2017 Page 13/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LIMPIDEX 15 mg capsule rigide not available 028755027 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg capsule rigide not available 028755039 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg capsule rigide not available 028755041 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg capsule rigide not available 028755027 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg capsule rigide not available 028755039 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg capsule rigide not available 028755041 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg compresse orodispersibili not available 028755078 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg compresse orodispersibili not available 028755080 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg compresse orodispersibili not available 028755078 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 15 mg compresse orodispersibili not available 028755080 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg capsule rigide not available 028755015 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg capsule rigide not available 028755054 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg capsule rigide not available 028755066 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg capsule rigide not available 028755015 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg capsule rigide not available 028755054 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg capsule rigide not available 028755066 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg compresse orodispersibili not available 028755092 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
-
EMA/727763/2017 Page 14/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LIMPIDEX 30 mg compresse orodispersibili not available 028755104 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg compresse orodispersibili not available 028755092 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
LIMPIDEX 30 mg compresse orodispersibili not available 028755104 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
Monolitum Flas 15 mg comprimidos bucodispersables
not available 71367 LABORATORIOS SALVAT, S.A. ES
Monolitum Flas 30 mg comprimidos bucodispersables
not available 71366 LABORATORIOS SALVAT, S.A. ES
OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 479-9 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 480-7 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 481-3 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 483-6 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 340 959-2 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 484-2 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 560 858-0 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 358 422-0 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 358 423-7 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 478-2 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 479-9 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 480-7 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 481-3 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 483-6 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 340 959-2 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 484-2 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 560 858-0 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 358 422-0 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 358 423-7 TAKEDA FRANCE S.A.S. FR OGAST 15 mg, gélule gastro-résistante DE/H/1699/001 345 478-2 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 344 552-4 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 343 039-1 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 343 041-6 TAKEDA FRANCE S.A.S. FR
-
EMA/727763/2017 Page 15/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 333 412-1 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 558 546-5 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 344 551-8 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 344 552-4 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 343 039-1 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 343 041-6 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 333 412-1 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 558 546-5 TAKEDA FRANCE S.A.S. FR OGAST 30 mg, gélule gastro-résistante DE/H/1699/002 344 551-8 TAKEDA FRANCE S.A.S. FR Ogasto 15 mg cápsulas gastrorresistentes DE/H/1699/001 3179496 LUSOMEDICAMENTA – SOCIEDADE
TÉCNICA FARMACÊUTICA, SA PT
Ogasto 15 mg cápsulas gastrorresistentes DE/H/1699/001 3179595 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg cápsulas gastrorresistentes DE/H/1699/001 3179694 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg cápsulas gastrorresistentes DE/H/1699/001 3179496 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg cápsulas gastrorresistentes DE/H/1699/001 3179595 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg cápsulas gastrorresistentes DE/H/1699/001 3179694 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg comprimidos orodispersíveis DE/H/1699/003 4027488 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg comprimidos orodispersíveis DE/H/1699/003 4027587 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg comprimidos orodispersíveis DE/H/1699/003 4027686 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg comprimidos orodispersíveis DE/H/1699/003 4027488 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg comprimidos orodispersíveis DE/H/1699/003 4027587 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 15 mg comprimidos orodispersíveis DE/H/1699/003 4027686 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
-
EMA/727763/2017 Page 16/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 2658599 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 2658698 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 2658797 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 3341898 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 2658599 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 2658698 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 2658797 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg cápsulas gastrorresistentes DE/H/1699/002 3341898 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg comprimidos orodispersíveis DE/H/1699/004 4027785 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg comprimidos orodispersíveis DE/H/1699/004 4027884 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg comprimidos orodispersíveis DE/H/1699/004 4027983 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg comprimidos orodispersíveis DE/H/1699/004 4027785 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg comprimidos orodispersíveis DE/H/1699/004 4027884 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
Ogasto 30 mg comprimidos orodispersíveis DE/H/1699/004 4027983 LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
PT
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 368 715-0 OU 34009 368 715 0 2
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 368 716-7 OU 34009 368 716 7 0
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 368 717-3 OU 34009 368 717 3 1
TAKEDA FRANCE S.A.S. FR
-
EMA/727763/2017 Page 17/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 392 394-6 OU 34009 392 394 6 0
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 392 395-2 OU 34009 392 395 2 1
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 392 396-9 OU 34009 392 396 9 9
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 368 715-0 OU 34009 368 715 0 2
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 368 716-7 OU 34009 368 716 7 0
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 368 717-3 OU 34009 368 717 3 1
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 392 394-6 OU 34009 392 394 6 0
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 392 395-2 OU 34009 392 395 2 1
TAKEDA FRANCE S.A.S. FR
OGASTORO 15 mg, comprimé orodispersible DE/H/1699/003 392 396-9 OU 34009 392 396 9 9
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 368 712-1 OU 34009 368 712 1 2
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 368 713-8 OU 34009 368 713 8 0
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 368 714-4 OU 34009 368 714 4 1
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 392 397-5 OU 34009 392 397 5 0
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 392 398-1 OU 34009 392 398 1 1
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 392 399-8 OU 34009 392 399 8 9
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 368 712-1 OU 34009 368 712 1 2
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 368 713-8 OU 34009 368 713 8 0
TAKEDA FRANCE S.A.S. FR
-
EMA/727763/2017 Page 18/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 368 714-4 OU 34009 368 714 4 1
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 392 397-5 OU 34009 392 397 5 0
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 392 398-1 OU 34009 392 398 1 1
TAKEDA FRANCE S.A.S. FR
OGASTORO 30 mg, comprimé orodispersible DE/H/1699/004 392 399-8 OU 34009 392 399 8 9
TAKEDA FRANCE S.A.S. FR
OPIREN 15 mg Cápsulas DE/H/1699/001 61.448 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
OPIREN 15 mg Cápsulas DE/H/1699/001 61.448 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
OPIREN 30 mg Cápsulas DE/H/1699/002 59.785 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
OPIREN 30 mg Cápsulas DE/H/1699/002 59.785 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
OPIREN FLAS 15 mg Comprimidos bucodispersables
DE/H/1699/003 65.474 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
OPIREN FLAS 15 mg Comprimidos bucodispersables
DE/H/1699/003 65.474 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
OPIREN FLAS 30 mg Comprimidos bucodispersables
DE/H/1699/004 65.475 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
OPIREN FLAS 30 mg Comprimidos bucodispersables
DE/H/1699/004 65.475 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
Pampe 15 mg cápsulas gastrorresistentes not available 5017348 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Pampe 15 mg, Cápsulas gastrorresistentes not available 5017330 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Prezal 15 mg, maagsapresistente capsule DE/H/1699/001 RVG 18696 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Prezal 15 mg, maagsapresistente capsule DE/H/1699/001 RVG 18696 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Prezal 15 mg, maagsapresistente capsule DE/H/1699/001 RVG 18696 SANOFI-AVENTIS NETHERLANDS B.V.
NL
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EMA/727763/2017 Page 19/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Prezal 30 mg, maagsapresistente capsule DE/H/1699/002 RVG 15420 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Prezal 30 mg, maagsapresistente capsule DE/H/1699/002 RVG 15420 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Prezal 30 mg, maagsapresistente capsule DE/H/1699/002 RVG 15420 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054218 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054232 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054269 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054220 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054271 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054081 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054093 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054283 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054055 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054321 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054257 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054042 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054295 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054131 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054129 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054117 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054028 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054067 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054079 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054319 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054156 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054168 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054170 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054182 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054194 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054016 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054206 TEVA ITALIA S.R.L. IT
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EMA/727763/2017 Page 20/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054105 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054244 TEVA ITALIA S.R.L. IT Tanzolan 15 mg capsule rigide gastroresistenti DE/H/3931/001 043054143 TEVA ITALIA S.R.L. IT Tanzolan 15 mg Capsule rigide gastroresistenti DE/H/3931/001 043054030 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054562 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054550 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054574 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054422 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054408 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054410 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054586 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054461 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054473 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054485 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054547 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054360 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054372 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054384 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054396 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054509 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054511 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054345 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054358 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054648 TEVA ITALIA S.R.L. IT Tanzolan 30 mg Capsule rigide gastroresistenti DE/H/3931/002 043054333 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054523 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054598 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054497 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054535 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054612 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054600 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054459 TEVA ITALIA S.R.L. IT Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054434 TEVA ITALIA S.R.L. IT
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EMA/727763/2017 Page 21/21
Product Name (in authorisation country) MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Tanzolan 30 mg capsule rigide gastroresistenti DE/H/3931/002 043054446 TEVA ITALIA S.R.L. IT Tanzolan 30 mg Capsule rigide gastroresistenti DE/H/3931/002 043054636 TEVA ITALIA S.R.L. IT Zoton 15 mg compresse orodispersibili IT/H/0226/003 028775070 PFIZER ITALIA S.R.L. IT Zoton 15 mg compresse orodispersibili IT/H/0226/003 028775082 PFIZER ITALIA S.R.L. IT Zoton 30 mg compresse orodispersibili IT/H/0226/004 028775094 PFIZER ITALIA S.R.L. IT Zoton 30 mg compresse orodispersibili IT/H/0226/004 028775106 PFIZER ITALIA S.R.L. IT Zoton FasTab 15 mg oro-dispersible tablets IT/H/0226/003 PA 0822/101/002 PFIZER HEALTHCARE IRELAND IE Zoton FasTab 30 mg oro-dispersible tablets IT/H/0226/004 PA 0822/101/003 PFIZER HEALTHCARE IRELAND IE Zoton FasTab* 15 mg oro-dispersible tablets IT/H/0226/003 PL 00057/1296 PFIZER LIMITED UK Zoton FasTab* 30 mg oro-dispersible tablets IT/H/0226/004 PL 00057/1297 PFIZER LIMITED UK
