fluoxetine: List of nationally authorised medicinal ... · List of nationally authorised medicinal...
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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 5525 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 17 May 2018 EMA/326378/2018 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: fluoxetine Procedure no.: PSUSA/00001442/201709
Transcript of fluoxetine: List of nationally authorised medicinal ... · List of nationally authorised medicinal...
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 5525 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
17 May 2018 EMA/326378/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: fluoxetine
Procedure no.: PSUSA/00001442/201709
List of nationally authorised medicinal products EMA/326378/2018 Page 2/88
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
ADOFEN 20 mg cápsulas duras
not available 58049 FERRER INTERNACIONAL, S.A.
ES
ADOFEN 20 mg comprimidos dispersables
not available 61419 FERRER INTERNACIONAL, S.A.
ES
Afeksin 20 mg soluble tablets
DK/H/0609/001 MA628/01801 ACTAVIS GROUP PTC EHF. MT
Andepin, 20 mg, kapsułki twarde
not available 10655 SYNTEZA SP. Z O.O. PL
BIOXETIN not available R/3723 SANOFI-AVENTIS SP Z.O.O. PL
BIOXETIN not available R/3723 SANOFI-AVENTIS SP Z.O.O. PL
DAGRILAN 20mg καψάκιο σκληρό
not available 3131/22-09-2011 MEDOCHEMIE HELLAS SA GR
DEPREX LÉČIVA tvrdé tobolky
not available 30/636/00-C ZENTIVA, K.S. CZ
DEPREX LÉČIVA tvrdé tobolky
not available 30/636/00-C ZENTIVA, K.S. CZ
Deprexetin, 20 mg, kapsułki twarde
not available 7476 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
List of nationally authorised medicinal products EMA/326378/2018 Page 3/88
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
DIESAN 20 mg /5 ml soluzione orale
not available 033162 025 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 mg /5 ml soluzione orale
not available 033162 025 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 mg /5 ml soluzione orale
not available 033162 025 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 MG CAPSULE RIGIDE
not available 033162 013 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 MG CAPSULE RIGIDE
not available 033162 037 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 MG CAPSULE RIGIDE
not available 033162 013 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 MG CAPSULE RIGIDE
not available 033162 037 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 MG CAPSULE RIGIDE
not available 033162 013 LABORATORIO FARMACEUTICO CT SRL
IT
DIESAN 20 MG CAPSULE RIGIDE
not available 033162 037 LABORATORIO FARMACEUTICO CT SRL
IT
List of nationally authorised medicinal products EMA/326378/2018 Page 4/88
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
DIGASSIM 20 mg cápsulas
not available 4539490 LABORATÓRIOS VITÓRIA, SA PT
DIGASSIM 20 mg cápsulas
not available 2219590 LABORATÓRIOS VITÓRIA, SA PT
DIGASSIM 20 mg cápsulas
not available 2051191 LABORATÓRIOS VITÓRIA, SA PT
EXOSTREPT 20mg/cap not available 65452/15-10-2014 NATURALIA S.A. GR
Felicium 20 mg Kapseln not available 1-21931 STADA ARZNEIMITTEL GMBH AT
Felicium 20 mg Tabletten NL/H/0354/001 1-25087 STADA ARZNEIMITTEL GMBH AT
FLONITAL not available 45124/4-11-2008 ANFARM HELLAS SA GR
Floxet 10 mg kemény kapszula
not available OGYI-T-5184/04 EGIS PHARMACEUTICALS PLC
HU
Floxet 10 mg kemény kapszula
not available OGYI-T-5184/04 EGIS PHARMACEUTICALS PLC
HU
List of nationally authorised medicinal products EMA/326378/2018 Page 5/88
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
Floxet 10 mg kemény kapszula
not available OGYI-T-5184/04 EGIS PHARMACEUTICALS PLC
HU
Floxet 20 mg kemény kapszula
not available OGYI-T-5184/01-02 EGIS PHARMACEUTICALS PLC
HU
Floxet 20 mg kemény kapszula
not available OGYI-T-5184/01-02 EGIS PHARMACEUTICALS PLC
HU
Floxet 20 mg kemény kapszula
not available OGYI-T-5184/01-02 EGIS PHARMACEUTICALS PLC
HU
Fluctine 20 mg - Kapseln FR/H/0242/002 1-18570 ELI LILLY GES. M.B.H AT
Fluoksetin Vitabalans 20 mg filmsko obložene tablete
FI/H/0751/001 H/11/00638/001 VITABALANS OY SI
Fluoksetin Vitabalans 20 mg filmsko obložene tablete
FI/H/0751/001 H/11/00638/002 VITABALANS OY SI
Fluoksetyna EGIS, 10 mg, kapsułki, twarde
not available 16702 EGIS PHARMACEUTICALS PLC
PL
Fluoksetyna EGIS, 20 mg, kapsułki, twarde
not available 16703 EGIS PHARMACEUTICALS PLC
PL
List of nationally authorised medicinal products EMA/326378/2018 Page 6/88
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
FLUOXEREN 20 mg capsule rigide
not available 025959014 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
FLUOXEREN 20 mg capsule rigide
not available 025959040 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
FLUOXEREN 20 mg compresse dispersibili
not available 025959038 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
FLUOXEREN 20 mg compresse dispersibili
not available 025959053 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
FLUOXEREN 20 mg/5 ml soluzione orale
not available 025959026 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
Fluoxetin "1A Farma" not available 39334 1A FARMA A/S DK
Fluoxetin "Mylan", hårde kapsler
DK/H/0118/001 18069 MYLAN AB DK
Fluoxetin "Sandoz" DK/H/0163/001 30285 SANDOZ GMBH DK
Fluoxetin ”Actavis” hårde kapsler
UK/H/0418/001 32866 ACTAVIS GROUP PTC EHF. DK
List of nationally authorised medicinal products EMA/326378/2018 Page 7/88
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
Fluoxetin ”Actavis” hårde kapsler
UK/H/0418/001 32866 ACTAVIS GROUP PTC EHF. DK
Fluoxetin ”Actavis”, opløselige tabletter
DK/H/0609/001 32552 ACTAVIS GROUP PTC EHF. DK
Fluoxetin ”Orifarm”, opløselige tabletter
not available 35376 ORIFARM GENERICS A/S DK
Fluoxetin 10 - 1 A Pharma®, Fluoxetin 10 mg pro Tablette
not available 40255.00.00 1 A PHARMA GMBH DE
Fluoxetin 10 mg (Tabletten)
not available 45785.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin 1A Pharma 20 mg - Kapseln
not available 1-24567 1A PHARMA GMBH AT
Fluoxetin 1A Pharma 20 mg - Tabletten
not available 1-25330 1A PHARMA GMBH AT
Fluoxetin 1A Pharma 40 mg - Tabletten
not available 1-25331 1A PHARMA GMBH AT
Fluoxetin 20 - 1 A Pharma®, Fluoxetin 20 mg pro Tablette
not available 40255.01.00 1 A PHARMA GMBH DE
List of nationally authorised medicinal products EMA/326378/2018 Page 8/88
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
Fluoxetin 20 mg (Hartkapseln)
not available 45822.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin 20 mg T (Tabletten)
not available 38345.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin 40 - 1 A Pharma®, Fluoxetin 40 mg pro Tablette
not available 40255.02.00 1 A PHARMA GMBH DE
Fluoxetin AbZ 20 mg Hartkapseln
not available 39676.00.00 ABZ-PHARMA GMBH DE
FLÚOXETÍN ACTAVIS 20 MG HYLKI, HÖRÐ
not available 990041 ACTAVIS HF. IS
Flúoxetín Actavis 20 mg lausnartöflur.
DK/H/0609/001 IS/1/06/005/01 ACTAVIS HF. IS
Fluoxetin AL 20 mg Tabletten
NL/H/0369/001 55610.00.00 ALIUD PHARMA GMBH DE
Fluoxetin Amdipharm 60 mg, Hartkapseln
NL/H/3535/005 2017070224 AMDIPHARM LIMITED LU
Fluoxetin Arcana 20 mg - Kapseln
DK/H/0118/001 1-22963 ARCANA ARZNEIMITTEL GMBH
AT
List of nationally authorised medicinal products EMA/326378/2018 Page 9/88
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
FLUOXETIN ARENA 10 mg capsule
not available 6320/2014/01 ARENA GROUP S.A RO
FLUOXETIN ARENA 10 mg capsule
not available 6320/2014/02 ARENA GROUP S.A RO
FLUOXETIN ARENA 20 mg capsule
not available 6321/2014/01 ARENA GROUP S.A RO
FLUOXETIN ARENA 20 mg capsule
not available 6321/2014/02 ARENA GROUP S.A RO
Fluoxetin beta 20 20 mg, Hartkapseln
not available 39458.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin beta 20, 20 mg, Tabletten
not available 40256.01.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin beta 40 40 mg, Tabletten
not available 40256.02.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin dura 20 mg Hartkapseln
DK/H/0118/001 40192.00.00 MYLAN DURA GMBH DE
Fluoxetin G.L. 20 mg-Filmtabletten
not available 1-30875 G.L. PHARMA GMBH AT
List of nationally authorised medicinal products EMA/326378/2018 Page 10/88
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
Fluoxetin G.L. 20 mg-Kapseln
not available 1-24603 G.L. PHARMA GMBH AT
Fluoxetin G.L. 40 mg-Filmtabletten
not available 1-30876 G.L. PHARMA GMBH AT
Fluoxetin Genericon 20 mg Kapseln
not available 1-22540 GENERICON PHARMA GESELLSCHAFT M.B.H.
AT
Fluoxetin Genericon 20 mg Tabletten
not available 1-24028 GENERICON PHARMA GESELLSCHAFT M.B.H.
AT
Fluoxetin Genericon 20 mg/5 ml orale Lösung
not available 1-24027 GENERICON PHARMA GESELLSCHAFT M.B.H.
AT
Fluoxetin Genericon 40 mg Kapseln
not available 1-24476 GENERICON PHARMA GESELLSCHAFT M.B.H.
AT
Fluoxetin HEXAL SE/H/0525/002 38720 HEXAL A/S DK
Fluoxetin HEXAL 10 mg Hartkapseln
not available 41582.00.00 HEXAL AG DE
Fluoxetin HEXAL 10 mg Tabletten
not available 40254.00.00 HEXAL AG DE
List of nationally authorised medicinal products EMA/326378/2018 Page 11/88
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
Fluoxetin HEXAL 20 mg Hartkapseln
not available 39459.00.00 HEXAL AG DE
Fluoxetin HEXAL 20 mg Tabletten
not available 40331.01.00 HEXAL AG DE
Fluoxetin HEXAL 40 mg Tabletten
not available 40254.02.00 HEXAL AG DE
Fluoxetin Mylan 20 mg Dispersible Tablets
SE/H/0518/001 17195 MYLAN AB SE
Fluoxetin Mylan 20 mg hörð hylki
not available 960058 MYLAN AB IS
Fluoxetin Mylan 20 mg kapsler, harde
not available 96-1210 MYLAN AB NO
Fluoxetin Mylan 20 mg kovat kapselit
not available 12373 MYLAN AB FI
Fluoxetin Mylan 20 mg, kapsel, hård
not available 13084 MYLAN AB SE
Fluoxetin Orifarm 20 mg, dispergerbar tablett
not available 19769 ORIFARM GENERICS A/S SE
List of nationally authorised medicinal products EMA/326378/2018 Page 12/88
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
Fluoxetin Polpharma, 20 mg, kapsułki twarde
not available 7703 ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA
PL
Fluoxetin ratiopharm 10 mg lösliga tabletter
FI/H/0105/003 17056 RATIOPHARM GMBH SE
Fluoxetin ratiopharm 20 mg lösliga tabletter
DE/H/1871/001 16383 RATIOPHARM GMBH SE
Fluoxetin ratiopharm 20 mg, dispergerbare tabletter
not available 99-1727 RATIOPHARM GMBH NO
Fluoxetin Sandoz 10 mg Tabletten
not available 40331.00.00 HEXAL AG DE
Fluoxetin Sandoz 20 mg dispergerbar tablett
SE/H/0525/002 18088 SANDOZ A/S SE
Fluoxetin Sandoz 20 mg dispergoituva tabletti
SE/H/0525/002 21757 SANDOZ A/S FI
Fluoxetin Sandoz 20 mg Hartkapseln
not available 39489.00.00 HEXAL AG DE
Fluoxetin Sandoz 20 mg tablett, dispergerbar
SE/H/0525/002 05-3820 SANDOZ A/S NO
List of nationally authorised medicinal products EMA/326378/2018 Page 13/88
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
Fluoxetin Sandoz 20 mg, hård kapsel
DK/H/0163/001 16120 SANDOZ GMBH SE
Fluoxetin Sandoz 40 mg Tabletten
not available 40331.02.00 HEXAL AG DE
Fluoxetin STADA 20 mg, dispergerbara tabletter
NL/H/0354/001 18804 STADA ARZNEIMITTEL AG SE
Fluoxetin STADA® 20 mg Hartkapseln
AT/H/0101/001 1-21930 STADA ARZNEIMITTEL AG AT
Fluoxetin STADA® 20 mg Hartkapseln
AT/H/0101/001 41795.00.00 STADAPHARM GMBH DE
Fluoxetin STADA® 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
NL/H/0354/001 41795.00.01 STADAPHARM GMBH DE
Fluoxetin Teva 20 mg hårda kapslar
UK/H/0310/001 16559 TEVA SWEDEN AB SE
Fluoxetin Vitabalans 20 mg Filmtabletten
FI/H/0751/001 81069.00.00 VITABALANS OY DE
Fluoxetin WH 20 mg hylki PT/H/1759/001/MR IS/1/17/010/01 WILLIAMS & HALLS EHF IS
List of nationally authorised medicinal products EMA/326378/2018 Page 14/88
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
Fluoxetin WH 20 mg hylki PT/H/1759/001/MR IS/1/17/010/01 WILLIAMS & HALLS EHF IS
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311253 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311261 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311279 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311303 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311311 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311329 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311337 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311345 ACCORD HEALTHCARE LIMITED
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 15/88
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
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311352 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311360 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311378 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg cápsulas
SE/H/0753/001 5311402 ACCORD HEALTHCARE LIMITED
PT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111016 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111028 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111030 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111042 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111055 ACCORD HEALTHCARE LIMITED
IT
List of nationally authorised medicinal products EMA/326378/2018 Page 16/88
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
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111067 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111079 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111081 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111093 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111105 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111117 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Accord 20 mg capsule rigide
SE/H/0753/001 041111129 ACCORD HEALTHCARE LIMITED
IT
Fluoxetina Almus 20 mg Cápsulas
not available 4279295 ALMUS, LDA PT
Fluoxetina Almus 20 mg Cápsulas
not available 4279394 ALMUS, LDA PT
List of nationally authorised medicinal products EMA/326378/2018 Page 17/88
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
Fluoxetina Almus 20 mg Cápsulas
not available 4279493 ALMUS, LDA PT
Fluoxetina Almus 20 mg cápsulas duras EFG
not available 63315 ALMUS FARMACEUTICA S.A ES
FLUOXETINA ALMUS 20 mg capsule rigide
not available 035033024 ALMUS S.R.L IT
Fluoxetina Alter 20 mg Cápsulas
not available 4620886 ALTER, S.A. PT
Fluoxetina Alter 20 mg Cápsulas
not available 3404787 ALTER, S.A. PT
Fluoxetina Alter 20 mg Cápsulas
not available 3404886 ALTER, S.A. PT
FLUOXETINA ANGELINI, 20 mg capsule rigide
not available 035873013 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
FLUOXETINA ANGELINI, 20 mg capsule rigide
not available 035873025 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
FLUOXETINA ANGELINI, 20 mg capsule rigide
not available 035873037 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
List of nationally authorised medicinal products EMA/326378/2018 Page 18/88
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
FLUOXETINA ANGELINI, 20 mg compresse dispersibili
not available 035873049 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
Fluoxetina Apotex 20 mg capsulas duras EFG
not available 64230 APOTEX ESPAÑA, S.L. ES
Fluoxetina Apotex 20 mg cápsulas duras EFG
SE/H/0753/001 72477 APOTEX EUROPE B.V. ES
Fluoxetina Apotex 20 mg cápsulas duras EFG
SE/H/0753/001 72477 APOTEX EUROPE B.V. ES
Fluoxetina Aristo 20 mg comprimidos dispersables EFG
not available 64.944 ARISTO PHARMA IBERIA, S.L.
ES
Fluoxetina Atral 20 mg Cápsulas
not available 5190863 LABORATÓRIOS ATRAL, S.A. PT
Fluoxetina Atral 20mg cápsulas
not available 5190871 LABORATÓRIOS ATRAL, S.A. PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 5628243 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 5628250 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 19/88
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
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 5628268 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 5628276 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 5628300 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 5628318 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 5628326 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 PT/H/1137/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 PT/H/1137/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 PT/H/1137/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 20 mg cápsulas
PT/H/1137/001 PT/H/1137/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 20/88
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
Fluoxetina Aurobindo 20 mg cápsulas duras EFG
PT/H/1137/001 79330 LABORATORIOS AUROBINDO S.L.U.
ES
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 5628334 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 5628342 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 5628367 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 5628375 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 5628409 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 5628417 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 PT/H/1137/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 PT/H/1137/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 21/88
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
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 PT/H/1137/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 PT/H/1137/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurobindo 60 mg cápsulas
PT/H/1137/002 5628359 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3748688 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3748787 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3748886 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3748985 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749082 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749181 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 22/88
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
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749280 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749389 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749488 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749587 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749785 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749884 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749983 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg Cápsulas
UK/H/0418/001 3749686 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Aurovitas 20 mg cápsulas duras EFG
PT/H/1517/001 81.547 AUROVITAS SPAIN,S.A.U. ES
List of nationally authorised medicinal products EMA/326378/2018 Page 23/88
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
Fluoxetina Azevedos 20 mg cápsulas
not available 5241302 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Fluoxetina Azevedos 20 mg cápsulas
not available 5241278 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Fluoxetina BASI 20 mg cápsulas
not available 5504394 LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A.
PT
Fluoxetina BASI 20 mg cápsulas
not available 5504295 LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A.
PT
FLUOXETINA BENEL 20 mg cápsulas duras EFG
not available 62.660 FARMALIDER, S.A. ES
Fluoxetina Bluepharma 20 mg cápsulas
not available 4428082 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Fluoxetina Bluepharma 20 mg cápsulas
not available 4428181 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Fluoxetina Bluepharma 20 mg cápsulas
not available 4427985 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Fluoxetina Ciclum 20 mg Cápsulas
not available 4511390 CICLUM FARMA UNIPESSOAL LDA.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 24/88
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
Fluoxetina Ciclum 20 mg Cápsulas
not available 3430998 CICLUM FARMA UNIPESSOAL LDA.
PT
Fluoxetina Ciclum 20 mg Cápsulas
not available 4511291 CICLUM FARMA UNIPESSOAL LDA.
PT
Fluoxetina Ciclum 20 mg Cápsulas
not available 3431095 CICLUM FARMA UNIPESSOAL LDA.
PT
Fluoxetina Ciclum 20 mg Cápsulas
not available 4511390 CICLUM FARMA UNIPESSOAL LDA.
PT
Fluoxetina Ciclum 20 mg Cápsulas
not available 3430998 CICLUM FARMA UNIPESSOAL LDA.
PT
Fluoxetina Ciclum 20 mg Cápsulas
not available 4511291 CICLUM FARMA UNIPESSOAL LDA.
PT
Fluoxetina Ciclum 20 mg Cápsulas
not available 3431095 CICLUM FARMA UNIPESSOAL LDA.
PT
Fluoxetina Cinfa 20 mg Cápsulas
not available 4428280 CINFA PORTUGAL, LDA. PT
Fluoxetina Cinfa 20 mg Cápsulas
not available 4428389 CINFA PORTUGAL, LDA. PT
List of nationally authorised medicinal products EMA/326378/2018 Page 25/88
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
Fluoxetina Cinfa 20 mg Cápsulas
not available 4821880 CINFA PORTUGAL, LDA. PT
fluoxetina cinfa 20 mg cápsulas duras EFG
not available 63.499 LABORATORIOS CINFA, S.A. ES
fluoxetina cinfa 20 mg comprimidos dispersables EFG
not available 62.722 LABORATORIOS CINFA, S.A. ES
Fluoxetina Combix 20 mg cápsulas duras EFG
not available 63.679 LABORATORIOS COMBIX, S.L.U.
ES
Fluoxetina Davur 20 mg capsulas duras EFG
not available 63.316 LABORATORIOS DAVUR SL ES
FLUOXETINA DERMOGEN 20 mg cápsulas duras EFG
not available 64.144 DERMOGEN FARMA, S.A. ES
FLUOXETINA DOC Generici 20 mg Capsule rigide
not available 033555018 DOC GENERICI S.R.L. IT
FLUOXETINA DOC Generici 20 mg Capsule rigide
not available 033555032 DOC GENERICI S.R.L. IT
FLUOXETINA DOC Generici 20 mg/5 ml Soluzione orale
not available 033555020 DOC GENERICI S.R.L. IT
List of nationally authorised medicinal products EMA/326378/2018 Page 26/88
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
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207023 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207062 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207035 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207047 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207100 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207112 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207011 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207050 EG S.P.A. IT
Fluoxetina EG 20 mg Capsule rigide
AT/H/0101/001 034207100 EG S.P.A. IT
List of nationally authorised medicinal products EMA/326378/2018 Page 27/88
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
FLUOXETINA EUROGENERICI 20 mg compresse orodispersibili
not available 034667028 EG S.P.A. IT
FLUOXETINA EUROGENERICI 20 mg compresse orodispersibili
not available 034667042 EG S.P.A. IT
Fluoxetina Farmoz 20 mg Cápsulas
not available 4278990 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Fluoxetina Farmoz 20 mg Cápsulas
not available 4279097 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Fluoxetina Farmoz 20 mg Cápsulas
not available 4279196 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
FLUOXETINA FIDIA 20 mg capsule rigide
not available 034917056 FIDIA FARMACEUTICI S.P.A IT
FLUOXETINA FIDIA 20 mg capsule rigide
not available 034917068 FIDIA FARMACEUTICI S.P.A IT
FLUOXETINA FIDIA 20 mg compresse solubili
not available 034917043 FIDIA FARMACEUTICI S.P.A IT
FLUOXETINA FIDIA 20 mg/5 m.1 soluzione orale
not available 034917017 FIDIA FARMACEUTICI S.P.A IT
List of nationally authorised medicinal products EMA/326378/2018 Page 28/88
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
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053016 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053028 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053030 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053042 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053055 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053067 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053079 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053081 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053093 GENERICS [UK] LIMITED IT
List of nationally authorised medicinal products EMA/326378/2018 Page 29/88
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
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053105 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053117 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053129 GENERICS [UK] LIMITED IT
Fluoxetina Generics 20 mg compresse dispersibili
SE/H/0518/001 037053131 GENERICS [UK] LIMITED IT
Fluoxetina Generis, 20 mg, cápsulas
not available 3653680 GENERIS FARMACÊUTICA, S.A.
PT
Fluoxetina Generis, 20 mg, cápsulas
not available 3653789 GENERIS FARMACÊUTICA, S.A.
PT
Fluoxetina Generis, 20 mg, cápsulas
not available 4582284 GENERIS FARMACÊUTICA, S.A.
PT
Fluoxetina Generis, 20 mg/5 ml, solução oral
not available 3653987 GENERIS FARMACÊUTICA, S.A.
PT
Fluoxetina Generis, 20 mg/5 ml, solução oral
not available 3653888 GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 30/88
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
Fluoxetina GERMED 20 mg capsule
not available 034897049 GERMED PHARMA S.R.L. IT
Fluoxetina GERMED 20 mg capsule
not available 034897052 GERMED PHARMA S.R.L. IT
Fluoxetina GERMED 20 mg compresse solubili
not available 034897025 GERMED PHARMA S.R.L. IT
Fluoxetina GERMED 20 mg compresse solubili
not available 034897064 GERMED PHARMA S.R.L. IT
Fluoxetina Germed 20 mg Cápsula
not available 4431680 GERMED FARMACÊUTICA, LDA.
PT
Fluoxetina Germed 20 mg Cápsula
not available 4431789 GERMED FARMACÊUTICA, LDA.
PT
Fluoxetina Germed 20 mg Cápsula
not available 4431888 GERMED FARMACÊUTICA, LDA.
PT
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 4807798 GP – GENÉRICOS PORTUGUESES, LDA.
PT
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 4807897 GP – GENÉRICOS PORTUGUESES, LDA.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 31/88
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
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 4807996 GP – GENÉRICOS PORTUGUESES, LDA.
PT
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 5715016 GP – GENÉRICOS PORTUGUESES, LDA.
PT
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 4807798 GP – GENÉRICOS PORTUGUESES, LDA.
PT
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 4807897 GP – GENÉRICOS PORTUGUESES, LDA.
PT
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 4807996 GP – GENÉRICOS PORTUGUESES, LDA.
PT
FLUOXETINA GP 20 mg Cápsulas
PT/H/1759/001/MR 5715016 GP – GENÉRICOS PORTUGUESES, LDA.
PT
Fluoxetina Jaba 20 mg Cápsulas
not available 4911194 JABA RECORDATI, S.A. PT
Fluoxetina Jaba 20 mg Cápsulas
not available 4911293 JABA RECORDATI, S.A. PT
Fluoxetina Jaba 20 mg Cápsulas
not available 4911095 JABA RECORDATI, S.A. PT
List of nationally authorised medicinal products EMA/326378/2018 Page 32/88
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
Fluoxetina KERN PHARMA 20 mg cápsulas duras EFG
not available 63.407 KERN PHARMA, S.L. ES
Fluoxetina Labesfal 20 mg cápsulas
not available 4431383 GENERIS FARMACÊUTICA, S.A.
PT
Fluoxetina Labesfal 20 mg cápsulas
not available 4431482 GENERIS FARMACÊUTICA, S.A.
PT
Fluoxetina Labesfal 20 mg cápsulas
not available 4431581 GENERIS FARMACÊUTICA, S.A.
PT
Fluoxetina Mabo 20 mg cápsulas duras EFG
not available 63.658 MABO-FARMA, S.A. ES
Fluoxetina Mepha 20 mg Cápsulas
not available 4910998 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
Fluoxetina Mepha 20 mg Cápsulas
not available 4910790 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
Fluoxetina Mepha 20 mg Cápsulas
not available 4910899 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 33/88
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
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2894988 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895084 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895183 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895282 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895381 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895480 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895589 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895886 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895688 MYLAN, LDA PT
List of nationally authorised medicinal products EMA/326378/2018 Page 34/88
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
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 2895787 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4008389 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 3963980 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 3963881 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4008587 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4008686 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4008488 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4008983 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4008785 MYLAN, LDA PT
List of nationally authorised medicinal products EMA/326378/2018 Page 35/88
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
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4008884 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4446787 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas
DK/H/0118/001 4009080 MYLAN, LDA PT
Fluoxetina Mylan 20 mg cápsulas duras EFG
DK/H/0118/001 62661 MYLAN PHARMACEUTICALS S.L.
ES
Fluoxetina Mylan 20 mg comprimidos dispersables EFG
not available 68093 MYLAN PHARMACEUTICALS S.L.
ES
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301011 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301023 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301035 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301047 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/326378/2018 Page 36/88
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
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301050 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301062 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301074 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301086 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301098 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301100 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301112 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301124 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301136 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/326378/2018 Page 37/88
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
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301148 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301151 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301163 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301175 MYLAN S.P.A. IT
Fluoxetina Mylan Generics 20 mg capsule rigide
DK/H/0118/001 035301187 MYLAN S.P.A. IT
Fluoxetina Nodepe 20 mg cápsulas
not available 4538898 ARISTO PHARMA IBERIA, S.L.
PT
Fluoxetina Nodepe 20 mg cápsulas
not available 4467197 ARISTO PHARMA IBERIA, S.L.
PT
Fluoxetina Nodepe 20 mg cápsulas
not available 4467296 ARISTO PHARMA IBERIA, S.L.
PT
Fluoxetina Nodepe 20 mg cápsulas
not available 4538997 ARISTO PHARMA IBERIA, S.L.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 38/88
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
Fluoxetina Nodepe 20 mg cápsulas
not available 2149391 ARISTO PHARMA IBERIA, S.L.
PT
Fluoxetina Nodepe 20 mg cápsulas
not available 4467395 ARISTO PHARMA IBERIA, S.L.
PT
FLUOXETINA NORMON 20 mg Cápsulas duras EFG
not available 62.426 LABORATORIOS NORMON, S.A.
ES
FLUOXETINA NORMON 20 mg/5 ml solución oral EFG
not available 62.427 LABORATORIOS NORMON, S.A.
ES
Fluoxetina Pensa 20 mg cápsulas duras EFG
not available 63.348 PENSA PHARMA, S.A ES
Fluoxetina Pharmakern 20 mg cápsulas
not available 3430394 PHARMAKERN PORTUGAL – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
PT
Fluoxetina Pharmakern 20 mg cápsulas
not available 3430493 PHARMAKERN PORTUGAL – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
PT
Fluoxetina Pharmakern 20 mg cápsulas
not available 4618989 PHARMAKERN PORTUGAL – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL,
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 39/88
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
LDA.
Fluoxetina Pharmakern 20 mg cápsulas
not available 3430592 PHARMAKERN PORTUGAL – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
PT
Fluoxetina Qualigen 20 mg cápsulas duras EFG
not available 64.229 QUALIGEN, S.L. ES
Fluoxetina ratio 20 mg cápsulas EFG
UK/H/0310/001 64.787 RATIOPHARM ESPANA SA ES
Fluoxetina ratiopharm 20 mg comprimidos dispersables EFG
FI/H/0105/002 64.443 RATIOPHARM ESPANA SA ES
Fluoxetina ratiopharm 20mg cápsulas
FI/H/0105/001 2843084 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Fluoxetina ratiopharm 20mg cápsulas
FI/H/0105/001 2842987 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Fluoxetina ratiopharm 20mg cápsulas
FI/H/0105/001 5026323 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Fluoxetina ratiopharm 20mg cápsulas
FI/H/0105/001 2842888 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 40/88
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
Fluoxetina ratiopharm 20mg cápsulas
FI/H/0105/001 4103586 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Fluoxetina ratiopharm 20mg cápsulas
FI/H/0105/001 2805083 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Fluoxetina ratiopharm 20mg cápsulas
FI/H/0105/001 2804987 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 41/88
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
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Ritisca 20 mg Cápsula
PT/H/1517/001 PT/H/1517/001 AUROVITAS UNIPESSOAL, LDA.
PT
Fluoxetina Salipax 20 mg Cápsulas
not available 2943686 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
Fluoxetina Salipax 20 mg Cápsulas
not available 2657088 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
Fluoxetina Salipax 20 mg Cápsulas
not available 4510087 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
Fluoxetina Salipax 20 mg Cápsulas
not available 4509980 MEPHA-INVESTIGACAO DESENVOLVIMENTO E FABRICACAO FARMACEUTICA, LDA.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 42/88
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
FLUOXETINA SANDOZ 20 MG CÁPSULAS
DK/H/0163/001 3200383 SANDOZ FARMACÊUTICA LDA.
PT
FLUOXETINA SANDOZ 20 MG CÁPSULAS
DK/H/0163/001 3200789 SANDOZ FARMACÊUTICA LDA.
PT
FLUOXETINA SANDOZ 20 MG CÁPSULAS
DK/H/0163/001 3200888 SANDOZ FARMACÊUTICA LDA.
PT
FLUOXETINA SANDOZ 20 MG CÁPSULAS
DK/H/0163/001 3200482 SANDOZ FARMACÊUTICA LDA.
PT
FLUOXETINA SANDOZ 20 MG CÁPSULAS
DK/H/0163/001 3200680 SANDOZ FARMACÊUTICA LDA.
PT
FLUOXETINA SANDOZ 20 MG CÁPSULAS
DK/H/0163/001 3200581 SANDOZ FARMACÊUTICA LDA.
PT
FLUOXETINA SANDOZ 20 MG CÁPSULAS
DK/H/0163/001 3200987 SANDOZ FARMACÊUTICA LDA.
PT
Fluoxetina Sandoz 20 mg cápsulas duras EFG
not available 62.146 SANDOZ FARMACÉUTICA, S.A.
ES
FLUOXETINA SANDOZ GMBH 20 mg capsule rigide
not available 033569017 SANDOZ GMBH IT
List of nationally authorised medicinal products EMA/326378/2018 Page 43/88
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
FLUOXETINA SANDOZ GMBH 20 mg capsule rigide
not available 033569056 SANDOZ GMBH IT
FLUOXETINA SANDOZ GMBH 20 mg capsule rigide
not available 033569068 SANDOZ GMBH IT
Fluoxetina STADA 20 mg cápsulas duras EFG
not available 62.481 LABORATORIO STADA, S.L. ES
FLUOXETINA TARBIS 20 mg cápsulas duras EFG
not available 63.126 TARBIS FARMA, S.L. ES
FLUOXETINA TARBIS 20 mg cápsulas duras EFG
not available 63.126 TARBIS FARMA, S.L. ES
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3632189 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3632080 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3631686 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3632387 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 44/88
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
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3631785 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3631983 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3631587 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3632288 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK-H-0310-001-MR 3632486 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3631884 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva 20 mg Cápsulas duras
UK/H/0310/001 3632585 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Fluoxetina Teva-Rimafar 20 mg cápsulas duras EFG
not available 64.592 TEVA PHARMA S.L.U ES
Fluoxetina toLife 20 mg Cápsulas
not available 5223185 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 45/88
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
Fluoxetina toLife 20 mg Cápsulas
not available 5223086 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Fluoxetina toLife 20 mg Cápsulas
not available 5223284 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Fluoxetina Tuneluz 20 mg cápsulas
not available 2050490 BALDACCI - PORTUGAL, S.A. PT
Fluoxetina Tuneluz 20 mg cápsulas
not available 2175693 BALDACCI - PORTUGAL, S.A. PT
Fluoxetina Tuneluz 20 mg cápsulas
not available 2175792 BALDACCI - PORTUGAL, S.A. PT
Fluoxetina Tuneluz 20 mg cápsulas
not available 2050391 BALDACCI - PORTUGAL, S.A. PT
Fluoxetina VIR 20 mg cápsulas duras EFG
not available 64.231 INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
ES
Fluoxetina Wynn 20 mg Cápsulas
not available 4142295 AXONE, LDA. PT
Fluoxetina Wynn 20 mg Cápsulas
not available 4142394 AXONE, LDA. PT
List of nationally authorised medicinal products EMA/326378/2018 Page 46/88
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
Fluoxetina Wynn 20 mg Cápsulas
not available 4142493 AXONE, LDA. PT
FLUOXETINA ZENTIVA 20 MG CÁPSULAS
not available 4536280 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
FLUOXETINA ZENTIVA 20 MG CÁPSULAS
not available 3416898 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
FLUOXETINA ZENTIVA 20 MG CÁPSULAS
not available 5914080 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
FLUOXETINA ZENTIVA 20 MG CÁPSULAS
not available 4536389 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Fluoxetina Zentiva 20 mg capsule rigide
not available 033910023 ZENTIVA ITALIA SRL IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850089 RATIOPHARM GMBH IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850014 RATIOPHARM GMBH IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850065 RATIOPHARM GMBH IT
List of nationally authorised medicinal products EMA/326378/2018 Page 47/88
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
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850077 RATIOPHARM GMBH IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850091 RATIOPHARM GMBH IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850038 RATIOPHARM GMBH IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850040 RATIOPHARM GMBH IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850053 RATIOPHARM GMBH IT
Fluoxetina-ratiopharm 20 mg compresse solubili
DE/H/1871/001 034850026 RATIOPHARM GMBH IT
Fluoxetin-CT 20 mg Hartkapseln
not available 49126.00.00 ABZ-PHARMA GMBH DE
Fluoxetine "Orion", hårde kapsler
DK/H/2645/001 57918 ORION CORPORATION DK
Fluoxetine ”Vitabalans”, filmovertrukne tabletter
FI/H/0751/001 46463 VITABALANS OY DK
List of nationally authorised medicinal products EMA/326378/2018 Page 48/88
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
Fluoxetine 10 mg Film-coated Tablets
not available PL 43808/0010 ENDO VENTURES LIMITED UK
Fluoxetine 10 mg hard capsules
not available PL 21880/0153 MEDREICH PLC UK
Fluoxetine 10mg hard capsules
not available PL 20117/0152 MORNINGSIDE HEALTHCARE LTD
UK
Fluoxetine 20 mg / 5 ml oral solution
not available PL 36390/0001 CIPLA (EU) LIMITED UK
Fluoxetine 20 mg / 5 ml Oral Solution
not available PL 20417/0045 FANNIN (UK) LIMITED UK
Fluoxetine 20 mg / 5 ml Oral Solution
not available PL 20417/0045 FANNIN (UK) LIMITED UK
Fluoxetine 20 mg / 5 ml Oral Solution
not available PL 20417/0045 FANNIN (UK) LIMITED UK
Fluoxetine 20 mg Capsules
not available PL 17907/0374 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
Fluoxetine 20 mg Capsules
not available PL 34976/0009 RI PHARMA LTD UK
List of nationally authorised medicinal products EMA/326378/2018 Page 49/88
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
Fluoxetine 20 mg Capsules
not available PL 16363/0064 MILPHARM LIMITED UK
Fluoxetine 20 mg Capsules
not available PL 28444/0017 ACTIVASE PHARMACEUTICALS LIMITED
UK
Fluoxetine 20 mg Capsules
not available PL 20075/0051 ACCORD HEALTHCARE LIMITED
UK
Fluoxetine 20 mg capsules, hard
PT/H/1137/001 MA807/08201 AUROBINDO PHARMA (MALTA) LIMITED
MT
Fluoxetine 20 mg Capsules, Hard
DK/H/0118/001 PL 04569/0414 GENERICS [UK] LIMITED UK
Fluoxetine 20 mg Hard Capsules
UK/H/4687/001 PA 1240/002/001 BRISTOL LABORATORIES LTD (BERKHAMSTED)
IE
Fluoxetine 20 mg Hard Capsules
UK/H/4687/001 PL 17907-0386 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
Fluoxetine 20 mg hard capsules
not available PL 25298/0105 BROWN & BURK UK LIMITED UK
Fluoxetine 20 mg hard capsules
not available PL 25298/0105 BROWN & BURK UK LIMITED UK
List of nationally authorised medicinal products EMA/326378/2018 Page 50/88
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
Fluoxetine 20 mg hard capsules
not available PL 25298/0105 BROWN & BURK UK LIMITED UK
Fluoxetine 20 mg hard capsules
not available PL 25298/0105 BROWN & BURK UK LIMITED UK
Fluoxetine 20 mg hard capsules
not available PL 25298/0105 BROWN & BURK UK LIMITED UK
Fluoxetine 20 mg hard capsules
not available PL 25298/0105 BROWN & BURK UK LIMITED UK
Fluoxetine 20 mg hard capsules
not available PL 25298/0105 BROWN & BURK UK LIMITED UK
Fluoxetine 20 mg Hard, Capsules
UK/H/0310/001 PL 14776/0036 TEVA PHARMA B.V. UK
Fluoxetine 20 mg, capsules
NL/H/0185/001 RVG 23896 UNICHEM LABORATORIES LIMITED
NL
Fluoxetine 20 PCH, capsules 20 mg
UK/H/0310/001 RVG 24467 PHARMACHEMIE B.V NL
Fluoxetine 20mg Capsules
UK/H/0418/001 PL 0142/0444 ACTAVIS UK LTD. UK
List of nationally authorised medicinal products EMA/326378/2018 Page 51/88
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
Fluoxetine 20mg Capsules
not available PL 13606/0146 STRIDES PHARMA UK LIMITED
UK
Fluoxetine 20mg Capsules
not available PL 43683/0001 AVER HEALTHCARE LTD UK
Fluoxetine 20mg Capsules
not available PL 13606/0146 STRIDES PHARMA UK LIMITED
UK
Fluoxetine 20mg Capsules
not available PL 20417/0046 FANNIN (UK) LIMITED UK
Fluoxetine 20mg Capsules
not available PL 20417/0046 FANNIN (UK) LIMITED UK
Fluoxetine 20mg Capsules
not available PL 44041/0016 NOUMED LIFE SCIENCES UK
Fluoxetine 20mg Capsules
not available PL 21880/0009 MEDREICH PLC UK
Fluoxetine 20mg Capsules
not available PL 20417/0046 FANNIN (UK) LIMITED UK
Fluoxetine 20mg Capsules
not available PL 13606/0146 STRIDES PHARMA UK LIMITED
UK
List of nationally authorised medicinal products EMA/326378/2018 Page 52/88
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
Fluoxetine 20mg Capsules
not available PL 13606/0146 STRIDES PHARMA UK LIMITED
UK
Fluoxetine 20mg Capsules
UK/H/0418/001 PL 0142/0444 ACTAVIS UK LTD. UK
Fluoxetine 20mg Capsules
not available PL20395/0003 RELON CHEM LIMITED UK
Fluoxetine 20mg Capsules, hard
UK/H/4895/001 PL 20117/0151 MORNINGSIDE HEALTHCARE LTD
UK
Fluoxetine 20mg Hard Capsules
not available PL 11311/0047 TILLOMED LABORATORIES LTD
UK
Fluoxetine 20mg Hard Capsules
not available 29831/0094 WOCKHARDT UK LTD UK
Fluoxetine 20mg Hard Capsules
not available PL 11311/0047 TILLOMED LABORATORIES LTD
UK
Fluoxetine 20mg/5ml Oral Solution
not available PL 17736 / 0062 CHEMIDEX PHARMA LIMITED UK
Fluoxetine 20mg/5ml Oral Solution
not available 04917/0038 PINEWOOD LABORATORIES LIMITED
UK
List of nationally authorised medicinal products EMA/326378/2018 Page 53/88
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
Fluoxetine 20mg/5ml Oral Solution
not available PL 17736 / 0126 CHEMIDEX PHARMA LIMITED UK
Fluoxetine 20mg/5ml Oral Solution
not available PL 20117/0197 MORNINGSIDE HEALTHCARE LTD
UK
Fluoxetine 30 mg hard capsules
not available PL 21880/0154 MEDREICH PLC UK
Fluoxetine 40 mg hard capsules
not available PL 21880/0155 MEDREICH PLC UK
Fluoxetine 60 mg Capsules, Hard
UK/H/0658/001 PL 04569/0477 GENERICS [UK] LIMITED UK
Fluoxetine 60 mg capsules, hard
PT/H/1137/002 PL 16363/0402 MILPHARM LIMITED UK
Fluoxetine 60 mg Hard Capsules
UK/H/4687/002 PA 1240/002/002 BRISTOL LABORATORIES LTD (BERKHAMSTED)
IE
Fluoxetine 60 mg hard capsules
not available PL 21880/0156 MEDREICH PLC UK
Fluoxetine 60 mg Hard Capsules
UK/H/4687/002 PL 17907/0387 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
List of nationally authorised medicinal products EMA/326378/2018 Page 54/88
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
Fluoxetine 60 mg Hard Capsules
UK/H/0972/001 PL 08553/0262 DR. REDDY'S LABORATORIES (UK) LTD.
UK
Fluoxetine 60mg Capsules
not available PL 20046/0288 FOCUS PHARMACEUTICALS LIMITED
UK
Fluoxetine Accord 20 mg kapsel, hård
SE/H/0753/001 42494 ACCORD HEALTHCARE LIMITED
SE
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 056 2 6 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 052 7 5 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 578 185 8 6 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 055 6 5 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 049 6 4 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 051 0 7 ACCORD HEALTHCARE FRANCE SAS
FR
List of nationally authorised medicinal products EMA/326378/2018 Page 55/88
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
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 046 7 4 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 045 0 6 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 053 3 6 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 578 186 4 7 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 050 4 6 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ACCORD 20 mg, gélule
not available 34009 494 047 3 5 ACCORD HEALTHCARE FRANCE SAS
FR
FLUOXETINE ALMUS 20 mg, gélule
not available 3400936889651 BIOGARAN FR
Fluoxetine Amdipharm 60 mg gélules
NL/H/3535/005 BE504675 AMDIPHARM LIMITED BE
Fluoxétine Amdipharm 60 mg gélules
NL/H/3535/005 34009 300 811 8 1 AMDIPHARM LIMITED FR
List of nationally authorised medicinal products EMA/326378/2018 Page 56/88
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
Fluoxétine Amdipharm 60 mg gélules
NL/H/3535/005 34009 300 811 7 4 AMDIPHARM LIMITED FR
Fluoxétine Amdipharm 60 mg gélules
NL/H/3535/005 34009 300 811 9 8 AMDIPHARM LIMITED FR
Fluoxétine Amdipharm 60 mg gélules
NL/H/3535/005 2017070224 AMDIPHARM LIMITED LU
Fluoxetine Amdipharm 60 mg harde capsules
NL/H/3535/005 BE504675 AMDIPHARM LIMITED BE
Fluoxetine Amdipharm 60 mg, harde capsules
NL/H/3535/001 RVG 118221 AMDIPHARM LIMITED NL
Fluoxetine Amdipharm 60 mg, Hartkapseln
NL/H/3535/005 BE504675 AMDIPHARM LIMITED BE
Fluoxetine Apotex 20 mg, capsules
not available RVG 24014 APOTEX EUROPE B.V. NL
Fluoxetine Apotex® 20 mg Capsules, hard
not available BE212904 APOTEX NV BE
FLUOXETINE ARROW 20 mg, comprimé dispersible sécable
not available 30600 ARROW GENERIQUES FR
List of nationally authorised medicinal products EMA/326378/2018 Page 57/88
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
FLUOXETINE ARROW 20 mg, comprimé dispersible sécable
not available 30600 ARROW GENERIQUES FR
FLUOXETINE ARROW 20 mg, comprimé dispersible sécable
not available 30600 ARROW GENERIQUES FR
FLUOXETINE ARROW 20 mg, comprimé dispersible sécable
not available 30600 ARROW GENERIQUES FR
FLUOXETINE ARROW 20 mg, gélule
not available 26810 ARROW GENERIQUES FR
FLUOXETINE ARROW 20 mg, gélule
not available 26810 ARROW GENERIQUES FR
FLUOXETINE ARROW 20 mg/5 ml, solution buvable
not available 26811 ARROW GENERIQUES FR
FLUOXETINE ARROW 20 mg/5 ml, solution buvable
not available 26811 ARROW GENERIQUES FR
Fluoxetine Aurobindo 20 mg tvrdé tobolky
PT/H/1137/001 30/005/15-C AUROBINDO PHARMA (MALTA) LIMITED
CZ
Fluoxetine Aurobindo 20 mg, capsules
UK/H/0418/001 RVG 26816 AUROBINDO PHARMA B.V. NL
List of nationally authorised medicinal products EMA/326378/2018 Page 58/88
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
Fluoxetine Aurobindo 20 mg, harde capsules
PT/H/1517/001 RVG 117874 AUROBINDO PHARMA B.V. NL
Fluoxetine Aurovitas, 20 mg, kapsułki, twarde
PT/H/1517/001 23796 AUROVITAS UNIPESSOAL, LDA.
PL
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400938385540 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400938414097 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400938385489 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400957211356 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400957211295 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400938385250 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400938385779 BIOGARAN FR
List of nationally authorised medicinal products EMA/326378/2018 Page 59/88
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
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400938385601 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, comprimé dispersible sécable
not available 3400938385311 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, gélule
not available 3400935485724 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg, gélule
not available 3400956264315 BIOGARAN FR
FLUOXETINE BIOGARAN 20 mg/5 ml SANS SUCRE, solution buvable édulcorée à la saccharine sodique et au cyclamate de sodium
not available 3400936453357 BIOGARAN FR
Fluoxetine Capsules 20 mg
NL/H/0200/001 PL 19611/0018 NICHE GENERICS LTD. UK
Fluoxetine CF 20, dispergeerbare tabletten 20 mg
NL/H/0354/001 RVG 24609 CENTRAFARM B.V. NL
FLUOXETINE CRISTERS 20 mg, comprimé dispersible sécable
not available 34009 391 332 7 0 CRISTERS FR
List of nationally authorised medicinal products EMA/326378/2018 Page 60/88
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
FLUOXETINE CRISTERS 20 mg, comprimé dispersible sécable
not available 34009 391 333 3 1 CRISTERS FR
FLUOXETINE CRISTERS 20 mg, comprimé dispersible sécable
not available 34009 391 335 6 0 CRISTERS FR
FLUOXETINE CRISTERS 20 mg, comprimé dispersible sécable
not available 34009 574 342 1 2 CRISTERS FR
FLUOXETINE CRISTERS 20 mg, comprimé dispersible sécable
not available 34009 574 343 8 0 CRISTERS FR
FLUOXETINE CRISTERS 20 mg, gélule
not available 34009 363 125 0 0 CRISTERS FR
FLUOXETINE CRISTERS 20 mg, gélule
not available 34009 565 136 3 5 CRISTERS FR
Fluoxetine Disper Mylan 20 mg, dispergeerbare tabletten
SE/H/0518/001 RVG 32369 MYLAN B.V. NL
Fluoxetine EG 20 mg comprimés dispersibles
NL/H/0354/001 BE280481 EUROGENERICS N.V./S.A. BE
Fluoxetine EG 20 mg dispergeerbare tabletten
NL/H/0354/001 BE280481 EUROGENERICS N.V./S.A. BE
List of nationally authorised medicinal products EMA/326378/2018 Page 61/88
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
Fluoxetine EG 20 mg gélules
not available BE211084 EUROGENERICS N.V./S.A. BE
Fluoxetine EG 20 mg gélules
not available 2009010012 EUROGENERICS N.V./S.A. LU
Fluoxetine EG 20 mg Hartkapseln
not available BE211084 EUROGENERICS N.V./S.A. BE
Fluoxetine EG 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
NL/H/0354/001 BE280481 EUROGENERICS N.V./S.A. BE
Fluoxetine EG 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
NL/H/0354/001 BE280481 EUROGENERICS N.V./S.A. BE
FLUOXETINE EG 20 mg, comprimé dispersible sécable
not available NL 33654 EG LABO LABORATOIRES EUROGENERICS
FR
FLUOXETINE EG 20 mg, gélule
not available NL 27136 EG LABO LABORATOIRES EUROGENERICS
FR
FLUOXETINE EVOLUGEN 20 mg, gélule
not available 34009 354 066 5 1 EVOLUPHARM FR
FLUOXETINE EVOLUGEN 20 mg, gélule
not available 34009 562 573 3 1 EVOLUPHARM FR
List of nationally authorised medicinal products EMA/326378/2018 Page 62/88
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
FLUOXETINE EVOLUGEN 20 mg, gélule
not available 34009 354 523 7 5 EVOLUPHARM FR
FLUOXETINE EVOLUGEN 20 mg, gélule
not available 34009 562 631 3 4 EVOLUPHARM FR
Fluoxetine Lannacher 20 mg cietās kapsulas
not available 99-0513 G.L. PHARMA GMBH LV
Fluoxetine Lannacher 20 mg kietosios kapsules
not available LT/1/99/0489/001 G.L. PHARMA GMBH LT
FLUOXETINE LBR 20 mg, gélule
not available 34009 571 911 5 3 BOUCHARA RECORDATI FR
FLUOXETINE LBR 20 mg, gélule
not available 34009 383 271 2 0 BOUCHARA RECORDATI FR
FLUOXETINE LBR 20 mg, gélule
not available 34009 383 272 9 8 BOUCHARA RECORDATI FR
FLUOXETINE LBR 20 mg, gélule
not available 34009 383 273 5 9 BOUCHARA RECORDATI FR
FLUOXETINE LBR 20 mg, gélule
not available 34009 383 274 1 0 BOUCHARA RECORDATI FR
List of nationally authorised medicinal products EMA/326378/2018 Page 63/88
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
FLUOXETINE LBR 20 mg, gélule
not available 34009 383 275 8 8 BOUCHARA RECORDATI FR
FLUOXETINE LBR 20 mg, gélule
not available 34009 571 912 1 4 BOUCHARA RECORDATI FR
Fluoxetine Mylan 20 mg capsules, hard
DK/H/0118/001 BE211181 MYLAN BVBA/SPRL BE
Fluoxetine Mylan 20 mg capsules, hard
DK/H/0118/001 BE211197 MYLAN BVBA/SPRL BE
Fluoxetine Mylan 20 mg gélules
DK/H/0118/001 1999030046 MYLAN BVBA/SPRL LU
Fluoxetine Mylan 20 mg, capsules
DK/H/0118/001 RVG 23696 MYLAN B.V. NL
Fluoxétine Mylan 20 mg, comprimé dispersible sécable
not available NL 28596 MYLAN S.A.S FR
FLUOXETINE MYLAN 20 mg, gélule
DK/H/0118/001 NL 24232 MYLAN S.A.S FR
Fluoxetine Orion 20 mg hårda kapslar
DK/H/2645/001 54918 ORION CORPORATION SE
List of nationally authorised medicinal products EMA/326378/2018 Page 64/88
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
Fluoxetine Orion 20 mg harde kapsler
DK/H/2645/001 16-11201 ORION CORPORATION NO
FLUOXETINE RANBAXY 20 mg, gélule
not available NL30014 RANBAXY PHARMACIE GENERIQUES
FR
FLUOXETINE RATIOPHARM 20 mg, gélule
not available NL23587 RATIOPHARM GMBH FR
Fluoxetine Sandoz 20 mg, capsules
not available RVG 30007 SANDOZ B.V. NL
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 377 149 4 5 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 377 150 2 7 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 377 151 9 5 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 377 152 5 6 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 377 153 1 7 SANDOZ FR
List of nationally authorised medicinal products EMA/326378/2018 Page 65/88
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
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 377 154 8 5 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 377 155 4 6 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 570 111 5 4 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, comprimé dispersible sécable
SE/H/0525/002 34009 570 112 1 5 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, gélule
not available 34009 354 072 5 2 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, gélule
not available 34009 365 842 1 1 SANDOZ FR
FLUOXETINE SANDOZ 20 mg, gélule
not available 34009 562 583 9 0 SANDOZ FR
Fluoxetine Sandoz, 20 mg, capsules, hard
DK/H/0163/001 BE217761 SANDOZ N.V. BE
Fluoxetine Teva 20 mg gélules
UK/H/0310/001 BE221006 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/326378/2018 Page 66/88
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
Fluoxetine Teva 20 mg harde capsules
UK/H/0310/001 BE221006 TEVA PHARMA BELGIUM N.V./S.A
BE
FLUOXETINE TEVA 20 mg HARTKAPSELN
UK/H/0310/001 BE221006 TEVA PHARMA BELGIUM N.V./S.A
BE
Fluoxetine Teva 20 mg, dispergeerbare tabletten
not available RVG 28139 TEVA NEDERLAND B.V. NL
FLUOXETINE TEVA 20 mg, gélule
not available NL26648 TEVA SANTÉ FR
FLUOXETINE TEVA SANTE 20 mg, comprimé dispersible sécable
not available NL26763 TEVA SANTÉ FR
Fluoxetine Unichem 20 mg, capsules
NL/H/0200/001 RVG 24400 UNICHEM LABORATORIES LIMITED
NL
Fluoxetine Vitabalans 20 mg apvalkotās tabletes
FI/H/0751/001 11-0245 VITABALANS OY LV
Fluoxetine Vitabalans 20 mg filmdragerade tabletter
FI/H/0751/001 43764 VITABALANS OY SE
Fluoxetine Vitabalans 20 mg filmdrasjerte tabletter
FI/H/0751/001 10-7362 VITABALANS OY NO
List of nationally authorised medicinal products EMA/326378/2018 Page 67/88
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
Fluoxetine Vitabalans 20 mg filmom obalené tablety
FI/H/0751/001 30/0280/11-S VITABALANS OY SK
Fluoxetine Vitabalans 20 mg filmtabletta
FI/H/0751/001 OGYI-T-21873/01 VITABALANS OY HU
Fluoxetine Vitabalans 20 mg filmtabletta
FI/H/0751/001 OGYI-T-21873/02 VITABALANS OY HU
Fluoxetine Vitabalans 20 mg filmtabletta
FI/H/0751/001 OGYI-T-21873/03 VITABALANS OY HU
Fluoxetine Vitabalans 20 mg filmtabletta
FI/H/0751/001 OGYI-T-21873/04 VITABALANS OY HU
Fluoxetine Vitabalans 20 mg filmtabletta
FI/H/0751/001 OGYI-T-21873/05 VITABALANS OY HU
Fluoxetine Vitabalans 20 mg kalvopäällysteiset tabletit
FI/H/0751/001 28309 VITABALANS OY FI
Fluoxetine Vitabalans 20 mg kalvopäällysteiset tabletit
FI/H/0751/001 28309 VITABALANS OY FI
Fluoxetine Vitabalans 20 mg plevele dengtos tabletes
FI/H/0751/001 LT/1/11/2540/004 VITABALANS OY LT
List of nationally authorised medicinal products EMA/326378/2018 Page 68/88
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
Fluoxetine Vitabalans 20 mg plevele dengtos tabletes
FI/H/0751/001 LT/1/11/2540/005 VITABALANS OY LT
Fluoxetine Vitabalans 20 mg plėvele dengtos tabletės
FI/H/0751/001 LT/1/11/2540/001 VITABALANS OY LT
Fluoxetine Vitabalans 20 mg plėvele dengtos tabletės
FI/H/0751/001 LT/1/11/2540/002 VITABALANS OY LT
Fluoxetine Vitabalans 20 mg plėvele dengtos tabletės
FI/H/0751/001 LT/1/11/2540/003 VITABALANS OY LT
Fluoxetine Vitabalans 20 mg potahované tablety
FI/H/0751/001 30/569/11-C VITABALANS OY CZ
Fluoxetine Vitabalans 20 mg tabletki powlekane
FI/H/0751/001 20324 VITABALANS OY PL
Fluoxetine Vitabalans, 20 mg õhukese polümeerikattega tabletid
FI/H/0751/001 747411 VITABALANS OY EE
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
List of nationally authorised medicinal products EMA/326378/2018 Page 69/88
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
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
Fluoxetine Vitama, 20 mg, kapsułki, twarde
PT/H/1137/001 22216 VITAMA S.A. PL
List of nationally authorised medicinal products EMA/326378/2018 Page 70/88
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
FLUOXETINE ZENTIVA 20 MG, COMPRIME DISPERSIBLE SECABLE
not available 379 386-3 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, COMPRIME DISPERSIBLE SECABLE
not available 570 879-0 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, COMPRIME DISPERSIBLE SECABLE
not available 379 388-6 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, COMPRIME DISPERSIBLE SECABLE
not available 379 385-7 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, COMPRIME DISPERSIBLE SECABLE
not available 570 880-9 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, GELULE
not available 562 578-5 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, GELULE
not available 354 070-2 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, GELULE
not available 562 576-2 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, GELULE
not available 367 456-1 SANOFI-AVENTIS FRANCE FR
List of nationally authorised medicinal products EMA/326378/2018 Page 71/88
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
FLUOXETINE ZENTIVA 20 MG, GELULE
not available 562 579-1 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZENTIVA 20 MG, GELULE
not available 562 577-9 SANOFI-AVENTIS FRANCE FR
FLUOXETINE ZYDUS 20 mg, comprimé dispersible sécable
not available 34009 380 440 8 9 ZYDUS FRANCE FR
FLUOXETINE ZYDUS 20 mg, comprimé dispersible sécable
not available 34009 380 441 4 0 ZYDUS FRANCE FR
FLUOXETINE ZYDUS 20 mg, comprimé dispersible sécable
not available 34009 380 442 0 1 ZYDUS FRANCE FR
FLUOXETINE ZYDUS 20 mg, comprimé dispersible sécable
not available 34009 571 018 9 3 ZYDUS FRANCE FR
FLUOXETINE ZYDUS 20 mg, comprimé dispersible sécable
not available 34009 571 019 5 4 ZYDUS FRANCE FR
FLUOXETINE ZYDUS 20 mg, gélule
not available 34009 358 251 1 7 ZYDUS FRANCE FR
FLUOXETINE ZYDUS 20 mg, gélule
not available 34009 358 252 8 5 ZYDUS FRANCE FR
List of nationally authorised medicinal products EMA/326378/2018 Page 72/88
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
FLUOXETINE ZYDUS 20 mg, gélule
not available 34009 563 385 6 6 ZYDUS FRANCE FR
FLUOXETINE ZYDUS 20 mg, gélule
not available 34009 563 386 2 7 ZYDUS FRANCE FR
Fluoxetin-neuraxpharm 10 mg Tabletten
not available 62145.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin-neuraxpharm 20 mg Hartkapseln
not available 62147.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin-neuraxpharm 20 mg T (Tabletten)
not available 62145.01.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin-neuraxpharm 40 mg Filmtabletten
not available 61327.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin-neuraxpharm 40 mg Filmtabletten
not available 61327.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Fluoxetin-ratiopharm 20 mg Tvrdé tobolky
not available 30/074/02-C RATIOPHARM GMBH CZ
Fluoxetin-ratiopharm® 20 mg Hartkapseln
not available 37109.00.00 RATIOPHARM GMBH DE
List of nationally authorised medicinal products EMA/326378/2018 Page 73/88
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
Fluoxetin-ratiopharm® 20 mg Hartkapseln
not available 2012030039 RATIOPHARM GMBH LU
Fluoxetin-ratiopharm® 20 mg Tabletten
DE/H/1871/001 49988.00.00 RATIOPHARM GMBH DE
Fluoxetin-ratiopharm® 20 mg Tabletten
not available 2012030038 RATIOPHARM GMBH LU
Fluoxetin-TEVA® 20 mg Hartkapseln
UK/H/0310/001 46531.00.00 TEVA GMBH DE
Fluoxetin-TEVA® 20 mg Tabletten
not available 46531.01.01 TEVA GMBH DE
Fluoxetin-Zentiva 20 mg kemény kapszula
not available OGYI-T-6826/02 ZENTIVA HU KFT HU
Fluoxetin-Zentiva 20 mg kemény kapszula
not available OGYI-T-6826/04 ZENTIVA HU KFT HU
Fluoxetin-Zentiva 20 mg kemény kapszula
not available OGYI-T-6826/03 ZENTIVA HU KFT HU
Fluoxetin-Zentiva 20 mg kemény kapszula
not available OGYI-T-6826/01 ZENTIVA HU KFT HU
List of nationally authorised medicinal products EMA/326378/2018 Page 74/88
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
Fluoxibene 20 mg - Kapseln
FI/H/0105/001 1-22739 TEVA B.V AT
Fluoxin 20 mg capsule not available 1006/2008/02 VIM SPECTRUM SRL RO
Fluoxin 20 mg capsule not available 1006/2008/01 VIM SPECTRUM SRL RO
Fluoxone 20 mg tabletti, päällystetty
FI/H/0156/001 16399 LABORATOIRES SMB S.A. FI
Fluoxone Divule 20 mg Überzogene Tablette
FI/H/0156/001 BE237955 LABORATOIRES SMB S.A. BE
Fluoxone Divule 20 mg Überzogene Tablette
FI/H/0156/001 2002060059 LABORATOIRES SMB S.A. LU
Fluoxone Divule 20 mg, comprimé enrobé
FI/H/0156/001 BE237955 LABORATOIRES SMB S.A. BE
Fluoxone Divule 20 mg, comprimé enrobé
FI/H/0156/001 2002060059 LABORATOIRES SMB S.A. LU
Fluoxone Divule 20 mg, omhulde tablet
FI/H/0156/01 BE237955 LABORATOIRES SMB S.A. BE
List of nationally authorised medicinal products EMA/326378/2018 Page 75/88
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
Fluoxtab 20 mg (Tabletten)
not available 45091.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Flustad, dispergeerbare tabletten 20 mg
NL/H/0369/001 RVG 28080 STADA ARZNEIMITTEL AG NL
Flux not available 379502 SANDOZ PHARMACEUTICALS D.D.
EE
Flux 20 mg kietosios kapsulės
not available LT/1/01/1462/002 SANDOZ PHARMACEUTICALS D.D.
LT
Flux 20 mg kietosios kapsulės
not available LT/1/01/1462/001 SANDOZ PHARMACEUTICALS D.D.
LT
Flux Hexal 20 mg - Kapseln
not available 1-23003 HEXAL PHARMA GMBH AT
Flux Hexal Tabs 20 mg -Tabletten
not available 1-24069 HEXAL PHARMA GMBH AT
Flux Hexal Tabs 40 mg - Tabletten
not available 1-24068 HEXAL PHARMA GMBH AT
Flux® 20 mg cietās kapsulas
not available 02-0310 SANDOZ PHARMACEUTICALS D.D.
LV
List of nationally authorised medicinal products EMA/326378/2018 Page 76/88
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
Fluxemed, 20 mg, kapsułki twarde
UK/H/4895/001 16055 PRO.MED.CS PRAHA A.S. PL
Fluxil 20 mg Capsules not available 19991 DELORBIS PHARMACEUTICALS LTD
CY
Fluxil 20 mg Capsules not available 115/00901 DELORBIS PHARMACEUTICALS LTD
MT
FluxoMed 20 mg Kapseln not available 1-22957 S.MED HANDELSGMBH AT
Fluzac 20mg Capsules not available PA0711/110/001 ROWEX LTD IE
Fluzak tvrdé tobolky not available 30/244/03-C SVUS PHARMA A.S. CZ
FODISS 20 mg disperzibilne tablete
SE/H/0518/001 5363-I-1982/08 GENERICS [UK] LIMITED SI
FOKESTON 20 mg σκληρά καψάκια
not available 43651/16-1-2009 RAFARM SA. GR
FOKESTON 20 mg/5ml Πόσιμο διάλυμα
not available 43650/08/16-1-2009 RAFARM SA. GR
List of nationally authorised medicinal products EMA/326378/2018 Page 77/88
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
Fontex 20 mg dispergerbar tablett
FR/H/0242/001 95-3722 ELI LILLY NORGE A.S. NO
Fontex 20 mg dispergerbar tablett
FR/H/0242/001 12892 ELI LILLY SWEDEN AB SE
Fontex 20 mg dreifitafla FR/H/0242/001 960037 ELI LILLY DANMARK A/S IS
Fontex 20 mg gélules FR/H/0242/002 BE201442 S.A. ELI LILLY BENELUX N.V. BE
Fontex 20 mg gélules FR/H/0242/002 2009060416 S.A. ELI LILLY BENELUX N.V. LU
Fontex 20 mg harde capsules
FR/H/0242/002 BE201442 S.A. ELI LILLY BENELUX N.V. BE
Fontex 4 mg/ml oral lösning
FR/H/0242/003 12136 ELI LILLY SWEDEN AB SE
Fontex, dispergible tabletter
FR/H/0242/001 17965 ELI LILLY DANMARK A/S DK
FONTEX® 20 mg Hartkapseln
FR/H/0242/002 BE201442 S.A. ELI LILLY BENELUX N.V. BE
List of nationally authorised medicinal products EMA/326378/2018 Page 78/88
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
Gerozac 20 mg Capsules, Hard
DK/H/0118/001 PA0405/036/001 GENERICS [UK] LIMITED IE
Gerozac 60mg Capsules, Hard
UK/H/0658/001 PA0577/071/001 MCDERMOTT LABORATORIES LTD
IE
Ladose 20 mg διασπειρόμενα δισκία
FR/H/0242/001 49665/02-09-2015 PHARMASERVE-LILLY SACI GR
Ladose 20 mg σκληρά καψάκια
FR/H/0242/002 49663/02-09-2015 PHARMASERVE-LILLY SACI GR
Ladose 20 mg/ 5 ml πόσιμο διάλυμα
FR/H/0242/003 49664/02-09-2015 PHARMASERVE-LILLY SACI GR
LURAMON 20 mg cápsulas duras Fluoxetina
not available 64.970 INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
ES
MAGRILAN 20 mg not available 30/0138/02-S MEDOCHEMIE LTD. SK
Magrilan 20 mg kietosios kapsulės
not available LT/1/99/1047/001 MEDOCHEMIE LTD. LT
MAGRILAN 20 mg, capsule
not available 380/2007/01 MEDOCHEMIE LTD. RO
List of nationally authorised medicinal products EMA/326378/2018 Page 79/88
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
MAGRILAN 20 mg, tvrdé tobolky
not available 30/443/00-C MEDOCHEMIE LTD. CZ
MAGRILAN 20mg capsules
not available 19891 MEDOCHEMIE LTD. CY
Magrilan 20mg capsules not available MA032/05301 MEDOCHEMIE LTD. MT
MEROPAN 20 mg capsules
not available 20013 CODAL SYNTO LTD CY
Mutan 20 mg-Filmtabletten
not available 1-20793 G.L. PHARMA GMBH AT
Mutan 20 mg-Kapseln not available 1-20794 G.L. PHARMA GMBH AT
Mutan 40 mg-Filmtabletten
not available 1-26154 G.L. PHARMA GMBH AT
Mutan 60 mg-Filmtabletten
not available 1-30873 G.L. PHARMA GMBH AT
Olena 20 mg Capsules not available PL 21880/0009 MEDREICH PLC UK
List of nationally authorised medicinal products EMA/326378/2018 Page 80/88
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
Olena 20mg Dispersible Tablets
UK/H/5297/001 PA 0899/042/001 MERCURY PHARMACEUTICALS LTD.
IE
Olena 20mg Dispersible Tablets
UK/H/5297/001 PL 12762/0475 MERCURY PHARMACEUTICALS LTD.
UK
Oxactin 20mg Capsules NL/H/0185/001 PL 19611/0017 NICHE GENERICS LTD. UK
Plazeron 20 mg Καψάκια not available 18665 REMEDICA LTD CY
Portal 20 mg trde kapsule not available 5363-I-1235/11 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Portal 20 mg trde kapsule not available 5363-I-1236/11 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Portal 20 mg tvrde kapsule
not available HR-H-581320968 SANDOZ D.O.O. HR
Prozac 20 mg cápsulas FR/H/0242/002 8716811 LILLY PORTUGAL - PRODUTOS FARMACÊUTICOS, LDA
PT
Prozac 20 mg cápsulas FR/H/0242/002 4581088 LILLY PORTUGAL - PRODUTOS FARMACÊUTICOS, LDA
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 81/88
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
PROZAC 20 mg cápsulas duras.
FR/H/0242/002 57.954 LILLY, S.A. (SPAIN) ES
PROZAC 20 mg capsule rigide
FR/H/0242/002 025970043 ELI LILLY ITALIA S.P.A. IT
Prozac 20 mg compresse dispersibili
FR/H/0242/001 025970056 ELI LILLY ITALIA S.P.A. IT
Prozac 20 mg comprimate orodispersabile
not available 7425/2006/02 LILLY, S.A. (SPAIN) RO
Prozac 20 mg comprimate orodispersabile
not available 7425/2006/01 LILLY, S.A. (SPAIN) RO
Prozac 20 mg comprimés dispersibles
FR/H/0242/001 BE198186 S.A. ELI LILLY BENELUX N.V. BE
Prozac 20 mg comprimés dispersibles
FR/H/0242/001 2009060414 S.A. ELI LILLY BENELUX N.V. LU
PROZAC 20 mg comprimidos dispersables
FR/H/0242/001 57.955 LILLY, S.A. (SPAIN) ES
Prozac 20 mg dispergeerbare tabletten
FR/H/0242/001 BE198186 S.A. ELI LILLY BENELUX N.V. BE
List of nationally authorised medicinal products EMA/326378/2018 Page 82/88
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
Prozac 20 mg dispergeerbare tabletten
FR/H/0242/001 RVG 19429 ELI LILLY NEDERLAND B.V. NL
Prozac 20 mg gélules FR/H/0242/002 BE135362 S.A. ELI LILLY BENELUX N.V. BE
Prozac 20 mg gélules FR/H/0242/002 2009060415 S.A. ELI LILLY BENELUX N.V. LU
Prozac 20 mg hard capsules
not available MA 001/00601 ELI LILLY AND COMPANY LIMITED
MT
Prozac 20 mg harde capsules
FR/H/0242/002 BE135362 S.A. ELI LILLY BENELUX N.V. BE
PROZAC 20 mg per 5 ml oral solution
FR/H/0242/003 PA 0047/077/001 ELI LILLY AND COMPANY LIMITED
IE
PROZAC 20 mg por 5 ml solución oral
FR/H/0242/003 60.289 LILLY, S.A. (SPAIN) ES
PROZAC 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
FR/H/0242/001 BE198186 S.A. ELI LILLY BENELUX N.V. BE
PROZAC 20 mg, comprimé dispersible sécable
FR/H/0242/001 345 052.5 LILLY FRANCE FR
List of nationally authorised medicinal products EMA/326378/2018 Page 83/88
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
PROZAC 20 mg, comprimé dispersible sécable
FR/H/0242/001 563 114.2 LILLY FRANCE FR
PROZAC 20 mg, comprimé dispersible sécable
FR/H/0242/001 345 053.1 LILLY FRANCE FR
PROZAC 20 mg, gélule FR/H/0242/002 331 008.9 LILLY FRANCE FR
PROZAC 20 mg, gélule FR/H/0242/002 556 284.3 LILLY FRANCE FR
PROZAC 20 mg, gélule FR/H/0242/002 331 009.5 LILLY FRANCE FR
Prozac 20 mg, tvrdé tobolky
not available 30/291/91-C ELI LILLY ČR, S.R.O. CZ
Prozac 20 mg/5 ml belsőleges oldat
not available OGYI-T-5012/01 ELI LILLY NEDERLAND B.V. HU
Prozac 20 mg/5 ml solução oral
FR/H/0242/003 2685188 LILLY PORTUGAL - PRODUTOS FARMACÊUTICOS, LDA
PT
PROZAC 20 mg/5 ml soluzione orale
FR/H/0242/003 025970029 ELI LILLY ITALIA S.P.A. IT
List of nationally authorised medicinal products EMA/326378/2018 Page 84/88
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
PROZAC 20 mg/5 ml, solution buvable en flacon
FR/H/0242/003 336 042.0 LILLY FRANCE FR
PROZAC 20mg per 5ml oral solution
FR/H/0242/003 PL 00006/0272 ELI LILLY AND COMPANY LIMITED
UK
Prozac* 20 mg hard capsules
FR/H/0242/002 PA 0047/077/002 ELI LILLY AND COMPANY LIMITED
IE
PROZAC* 20mg hard capsules
FR/H/0242/002 PL 00006/0195 ELI LILLY AND COMPANY LIMITED
UK
PROZAC® 20 mg Hartkapseln
FR/H/0242/002 BE135362 S.A. ELI LILLY BENELUX N.V. BE
Prozamel 20 mg Capsules, Hard
not available PA0126/110/001 CLONMEL HEALTHCARE LTD. IE
Prozep 20mg/5ml Oral Solution
not available PL 17736 / 0062 CHEMIDEX PHARMA LIMITED UK
Prozit 20mg Hard Capsules
NL/H/0200/001 PA 1063/012/001 NICHE GENERICS LTD. IE
Psipax 20 mg cápsulas not available 5454194 LECIFARMA - LABORATÓRIO FARMAC~EUTICO, LDA.
PT
List of nationally authorised medicinal products EMA/326378/2018 Page 85/88
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
Psipax 20 mg cápsulas not available 9768465 LECIFARMA - LABORATÓRIO FARMAC~EUTICO, LDA.
PT
Psipax 20 mg cápsulas not available 9768424 LECIFARMA - LABORATÓRIO FARMAC~EUTICO, LDA.
PT
Psipax 20mg capsules not available 4581393 LECIFARMA - LABORATÓRIO FARMAC~EUTICO, LDA.
PT
RENEURON 20 mg cápsulas duras
not available 58.022 EXELTIS HEALTHCARE S.L ES
RENEURON 20 mg comprimidos dispersables
not available 61.312 EXELTIS HEALTHCARE S.L ES
SARTUZIN® not available 12542 HELP ABEE GR
SARTUZIN® not available 12542 HELP ABEE GR
Seromex 10 mg liukeneva tabletti
FI/H/0105/003 15089 RATIOPHARM GMBH FI
Seromex 10 mg lösliga tabletter
FI/H/0105/003 15089 RATIOPHARM GMBH FI
List of nationally authorised medicinal products EMA/326378/2018 Page 86/88
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
Seromex 20 mg hylki FI/H/0105/001 IS/1/12/135/01 RATIOPHARM GMBH IS
Seromex 20 mg kapseli, kova
FI/H/0105/001 12422 RATIOPHARM GMBH FI
Seromex 20 mg kapseli, kova
FI/H/0105/001 12422 RATIOPHARM GMBH FI
Seromex 20 mg liukeneva tabletti
FI/H/0105/002 13995 RATIOPHARM GMBH FI
Seromex 20 mg lösliga tabletter
FI/H/0105/002 13995 RATIOPHARM GMBH FI
Seronil 10 mg filmdragerade tabletter
not available 11421 ORION OYJ FI
Seronil 10 mg tabletki powlekane
not available R/3743 ORION CORPORATION PL
Seronil 10 mg tabletti, kalvopäällysteinen
not available 11421 ORION OYJ FI
Seronil 20 mg kapsel, hård
not available 10874 ORION OYJ FI
List of nationally authorised medicinal products EMA/326378/2018 Page 87/88
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
Seronil 20 mg kapseli, kova
not available 10874 ORION OYJ FI
Seronil 60 mg filmdragerade tabletter
not available 12610 ORION OYJ FI
Seronil 60 mg tabletti, kalvopäällysteinen
not available 12610 ORION OYJ FI
Seronil, 20 mg, kapsułki twarde
not available R/3744 ORION CORPORATION PL
SOFELIN not available 6180 GALENUS PHARMACEUTICALS SA
GR
STEPHADILAT-S not available 40062 BROS LTD GR
STEPHADILAT-S not available 40063 BROS LTD GR
XEREDIEN 20 mg compresse dispersibili
not available 034974028 VALEAS S.P.A. IT
XEREDIEN 20 mg compresse dispersibili
not available 034974042 VALEAS S.P.A. IT
List of nationally authorised medicinal products EMA/326378/2018 Page 88/88
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
XEREDIEN 20 mg/5 ml soluzione orale
not available 034974030 VALEAS S.P.A. IT
ZINOVAT® Caps 20 mg/cap
not available 8570/06.02.2007 (EOF PRODUCT CODE: 2458804)
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
ZINOVAT® Chew. tablets 20 mg/tab
not available 8570/06.02.2007 (EOF PRODUCT CODE: 2458805)
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
ZINOVAT® Eff. tablets 20 mg/tab
not available 8570/06.02.2007 (EOF PRODUCT CODE: 2458803)
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
ZINOVAT® Oral sol. 20 mg/5ml
not available 6267/06/22.03.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
ZINOVAT® Oral sol. s.d. 20 mg/5ml VIAL
not available 20290/22.03.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
БИФЛОКС 20 MG ТВЪРДИ КАПСУЛИ
not available 20010839 ACTAVIS EAD BG
СОФЛУКСЕН 20 mg твърди капсули
not available 20020762 SOPHARMA AD BG
