active substance: citalopram procedure no.: …...prefucet not available 7784 rafarm sa. gr . list...
TRANSCRIPT
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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, 2017. Reproduction is authorised provided the source is acknowledged.
1 September 2017 EMA/583896/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: citalopram
Procedure no.: PSUSA/00000779/201612
List of nationally authorised medicinal products EMA/583896/2017 Page 2/93
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
Citalostad 20 mg Filmtabletten
not available 1-25317 STADA ARZNEIMITTEL GMBH
AT
Citalopram 20 mg AbZ NL/H/0468/002 RVG 27643 ABZ-PHARMA GMBH NL Citalopram 40 mg AbZ NL/H/0468/003 RVG 27644 ABZ-PHARMA GMBH NL Citalopram AbZ 20 mg Filmtabletten
NL/H/0468/002 58953.01.00 ABZ-PHARMA GMBH DE
Citalopram AbZ 40 mg Filmtabletten
NL/H/0468/003 58953.02.00 ABZ-PHARMA GMBH DE
Citalopram Azevedos 10 mg comprimidos revestidos por película
not available 5063805 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 10 mg comprimidos revestidos por película
not available 5063813 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 10 mg comprimidos revestidos por película
not available 5063821 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 20 mg comprimidos revestidos por pelicula
not available 5063847 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 20 mg comprimidos revestidos por pelicula
not available 5063854 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 20 mg comprimidos revestidos por pelicula
not available 5063862 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 40 mg comprimidos revestidos por película
not available 5063904 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 40 mg comprimidos revestidos por película
not available 5063912 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 40 mg comprimidos revestidos por película
not available 5063920 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 3/93
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
Citalopram Azevedos 10 mg comprimidos revestidos por película.
not available 5063771 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 20 mg comprimidos revestidos por película.
not available 5063839 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citalopram Azevedos 40 mg comprimidos revestidos por película.
not available 5063870 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Citaloprol 40 mg/ml Πόσιμες σταγόνες διάλυμα
not available 2416/3-3-2011 NOVENDIA PHARMACEUTICALS LTD
GR
LINISAN 10 mg comprimate filmate
not available 7778/2006/01 GEDEON RICHTER ROMÂNIA S.A.
RO
LINISAN 20 mg comprimate filmate
not available 7779/2006/01 GEDEON RICHTER ROMÂNIA S.A.
RO
CITALOPRAM SIGMA-TAU 40 mg/ml gocce orali, soluzione
not available 036723017 SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
IT
Citalopram-neuraxpharm 30 mg Filmtabletten
not available 63286.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Citalopram Genedec 10 mg comprimidos revestidos por película
not available 5449491 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalopram Genedec 10 mg comprimidos revestidos por película
not available 5449590 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalopram Genedec 20 mg comprimidos revestidos por película
not available 5449798 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalopram Genedec 20 mg comprimidos revestidos por película
not available 5449897 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 4/93
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
Citalopram Genedec 40 mg comprimidos revestidos por película
not available 5450093 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalopram Genedec 40 mg comprimidos revestidos por película
not available 5450192 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalopram Genedec 10 mg comprimidos revestidos por película
not available 5449392 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalopram Genedec 20 mg comprimidos revestidos por película
not available 5449699 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalopram Genedec 40 mg comprimidos revestidos por película
not available 5449996 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Citalostad 40 mg Filmtabletten
not available 1-25316 STADA ARZNEIMITTEL GMBH
AT
Citalopram 20 mg Holsten
not available 59744.00.00 HOLSTEN PHARMA GMBH DE
Citalopram-Hormosan 20 mg
not available 54073.01.00 HORMOSAN PHARMA GMBH DE
Citalopram-Hormosan 40 mg
not available 54073.02.00 HORMOSAN PHARMA GMBH DE
Citalopram-Hormosan 20 mg/ml Tropfen zum Einnehmen, Lösung
DE/H/4478/001 95290.00.00 HORMOSAN PHARMA GMBH DE
ROPRAMIN® not available 38706/12/06-06-2013 IASIS PHARMA GR ROPRAMIN not available 20742 IASIS PHARMA CY ROPRAMIN not available 20743 IASIS PHARMA CY ROPRAMIN® not available 44633/06-06-2013 IASIS PHARMA GR ROPRAMIN® not available 42132/11/23-01-2013 IASIS PHARMA GR PREFUCET not available 13959 RAFARM SA. GR PREFUCET not available 13960 RAFARM SA. GR PREFUCET not available 7784 RAFARM SA. GR
List of nationally authorised medicinal products EMA/583896/2017 Page 5/93
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
Citalopram Orion 40 mg filmdragerad tablett
FI/H/600/03 20584 ORION CORPORATION FI
Citalopram Orion 20 mg FILMDRAGERAD TABLETT
FI/H/0600/002 20583 ORION CORPORATION FI
Citalopram Orion 10 mg filmdragerad tablett
FI/H/600/01 20582 ORION CORPORATION FI
Citronil 10 mg, tabletki powlekane
FI/H/0600/001 12662 ORION CORPORATION PL
Citalopram Orion 10 mg potahované tablety
FI/H/0600/001 30/003/07-C ORION CORPORATION CZ
Citalopram Orion, filmovertrukne tabletter
FI/H/0600/001 39632 ORION CORPORATION DK
Citalopram Orion 10 mg tabletti, kalvopäällysteinen
FI/H/600/01 20582 ORION CORPORATION FI
Citalopram Orion 10 mg filmtabletta
FI/H/0600/001 OGYI-T-20342/01 ORION CORPORATION HU
Citalopram Orion 10 mg tabletter, filmdrasjerte
FI/H/0600/001 06-4251 ORION CORPORATION NO
Citalopram Orion 10 mg filmdragerade tabletter
FI/H/0600/001 24108 ORION CORPORATION SE
Citalopram Orion 10 mg, filmom obalené tablety
FI/H/0600/001 30/0518/06-S ORION CORPORATION SK
Citronil 20 mg, tabletki powlekane
FI/H/0600/002 12663 ORION CORPORATION PL
Citalopram Orion 20 mg potahované tablety
FI/H/0600/002 30/004/07-C ORION CORPORATION CZ
Citalopram Orion, filmovertrukne tabletter
FI/H/0600/002 39633 ORION CORPORATION DK
Citalopram Orion 20 mg tabletti, kalvopäällysteinen
FI/H/0600/002 20583 ORION CORPORATION FI
Citalopram Orion 20 mg filmtabletta
FI/H/0600/002 OGYI-T-20342/02 ORION CORPORATION HU
List of nationally authorised medicinal products EMA/583896/2017 Page 6/93
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
Citalopram Orion 20 mg tabletter, filmdrasjerte
FI/H/0600/002 06-4252 ORION CORPORATION NO
Citalopram Orion 20 mg filmdragerade tabletter
FI/H/0600/002 24109 ORION CORPORATION SE
Citalopram Orion 20 mg, filmom obalené tablety
FI/H/0600/002 30/0519/06-S ORION CORPORATION SK
Citronil 40 mg, tabletki powlekane
FI/H/0600/003 12661 ORION CORPORATION PL
Citalopram Orion 40 mg potahované tablety
FI/H/0600/003 30/005/07-C ORION CORPORATION CZ
Citalopram Orion, filmovertrukne tabletter
FI/H/0600/003 39634 ORION CORPORATION DK
Citalopram Orion 40 mg tabletti, kalvopäällysteinen
FI/H/0600/003 20584 ORION CORPORATION FI
Citalopram Orion 40 mg filmtabletta
FI/H/0600/003 OGYI-T-20342/03 ORION CORPORATION HU
Citalopram Orion 40 mg tabletter, filmdrasjerte
FI/H/0600/003 06-4253 ORION CORPORATION NO
Citalopram Orion 40 mg filmdragerade tabletter
FI/H/0600/003 24110 ORION CORPORATION SE
Citalopram Orion 40 mg, filmom obalené tablety
FI/H/0600/003 30/0520/06-S ORION CORPORATION SK
Citalopram Generis 10 mg comprimidos revestidos por película
not available 5582143 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram Generis 10 mg comprimidos revestidos por película
not available 5582150 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram Generis 10 mg comprimidos revestidos por película
not available 5582168 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram Generis 20 mg comprimidos revestidos por película
not available 5582176 GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 7/93
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
Citalopram Generis 20 mg comprimidos revestidos por película
not available 5582200 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram Generis 20 mg comprimidos revestidos por película
not available 5582218 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram Generis 40 mg comprimidos revestidos por película
not available 5582473 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram Generis 40 mg comprimidos revestidos por película
not available 5582507 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram Generis 40 mg comprimidos revestidos por película
not available 5582515 GENERIS FARMACÊUTICA, S.A.
PT
Citalopram 10 mg Tablets
not available PL 06464/1971 WAYMADE PLC UK
Citalopram 20 mg Tablets
not available PL 06464/1972 WAYMADE PLC UK
Citalopram 40 mg Tablets
not available PL 06464/1974 WAYMADE PLC UK
SEROR 20mg επικαλυμμένα με λεπτό υμένιο δισκία.
not available 20301/17-10-2012 SPECIFAR S.A. GR
SEROR 40mg επικαλυμμένα με λεπτό υμένιο δισκία
not available 72413/17-10-2012 SPECIFAR S.A. GR
ZECLICID f.c.tabs 20 mg/tab
not available 43642/12 VERISFIELD (UK) LTD GR
ZECLICID not available 43643/12 VERISFIELD (UK) LTD GR ZECLICID not available 43641/12 VERISFIELD (UK) LTD GR Citalopram 10mg Film-coated Tablets
not available PA688/8/1 CHANELLE MEDICAL IE
Citalopram 20mg Film-coated Tablets
not available PA688/8/2 CHANELLE MEDICAL IE
List of nationally authorised medicinal products EMA/583896/2017 Page 8/93
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
Citalopram 40mg Film-coated Tablets
not available PA688/8/3 CHANELLE MEDICAL IE
Citalopram Genericon 40 mg Filmtabletten
not available 1-24726 GENERICON PHARMA GESELLSCHAFT M.B.H.
AT
SEREGRA 20 mg comprimidos recubiertos con película EFG
not available 69163 ARAFARMA GROUP, S.A ES
SEREGRA 30 mg comprimidos recubiertos con película EFG
not available 69164 ARAFARMA GROUP, S.A ES
Citalopram 40mg/ml Oral drops, Solution
not available PL 00289/1460 TEVA UK LIMITED UK
Citalopram Hennig® 10 mg Filmtabletten
not available 54076.00.00 HENNIG ARZNEIMITTEL GMBH & CO. KG
DE
Citalopram Ranbaxy Italia 40 mg/ml gocce orali, soluzione
not available 036651014 RANBAXY ITALIA S.P.A. IT
CITALOPRAM EG 20 mg, comprimé pelliculé sécable
not available NL29726 EG LABO - LABORATOIRES EUROGENERICS
FR
Citalopram TARBIS 20 mg comprimidos recubiertos con película EFG
not available 66.347 TARBIS FARMA, S.L. ES
Citaxin, 20 mg, tabletki powlekane
not available 16319 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
Citalopram "Orifarm", filmovertrukne tabletter
DK/H/1007/001 35254 ORIFARM GENERICS A/S DK
Citalopram "Orifarm", filmovertrukne tabletter
DK/H/1007/002 35255 ORIFARM GENERICS A/S DK
Citalopram "Orifarm", filmovertrukne tabletter
DK/H/1007/003 35256 ORIFARM GENERICS A/S DK
Citalopram "Orifarm", filmovertrukne tabletter
DK/H/1007/004 35257 ORIFARM GENERICS A/S DK
VAROM ® not available 41595/12/18-02-2013 LYOFIN LTD, GREECE GR
List of nationally authorised medicinal products EMA/583896/2017 Page 9/93
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
VAROM ® not available 41596/12/18-02-2013 LYOFIN LTD, GREECE GR CILOPRESS not available 56706/14-09-2011 SJA PHARM LTD GR Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 5619960 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 5619978 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 5620000 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 5620018 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 10/93
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
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
CITALOPRAM AUROBINDO ITALIA 40 mg/ml gocce orali, soluzione
not available 036660037 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
CITALOPRAM ALTER 20 mg, comprimé pelliculé sécable
not available 6 284 571 3 LABORATOIRES ALTER FR
Citalopram Bluefish 10 mg filmomhulde tabletten
NL/H/1601/001 RVG 29755 BLUEFISH PHARMACEUTICALS AB
NL
List of nationally authorised medicinal products EMA/583896/2017 Page 11/93
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
Citalopram Bluefish 20 mg filmomhulde tabletten
NL/H/1601/002 RVG 29756 BLUEFISH PHARMACEUTICALS AB
NL
Citalopram Bluefish 40 mg filmomhulde tabletten
NL/H/1601/003 RVG 29757 BLUEFISH PHARMACEUTICALS AB
NL
Citalopram Bluefish 10 mg Filmtabletten
NL/H/1601/001 1-28965 BLUEFISH PHARMACEUTICALS AB
AT
Citalopram Bluefish 20 mg Filmtabletten
NL/H/1601/002 1-28966 BLUEFISH PHARMACEUTICALS AB
AT
Citalopram Bluefish 40 mg Filmtabletten
NL/H/1601/003 1-28967 BLUEFISH PHARMACEUTICALS AB
AT
CITALOPRAM BLUEFISH 20 mg, comprimé pelliculé sécable
NL/H/1601/002 217 217-1 OU 34009 217 217 1 3 BLUEFISH PHARMACEUTICALS AB
FR
Citalopram Bluefish 10 mg film-coated tablets
NL/H/1601/001 PA 1436/18/1 BLUEFISH PHARMACEUTICALS AB
IE
Citalopram Bluefish 20 mg film-coated tablets
NL/H/1601/002 PA 1436/18/2 BLUEFISH PHARMACEUTICALS AB
IE
Citalopram Bluefish 40 mg film-coated tablets
NL/H/1601/003 PA 1436/18/3 BLUEFISH PHARMACEUTICALS AB
IE
Citalopram Bluefish 10 mg filmdragerade tabletter
NL/H/1601/001 42877 BLUEFISH PHARMACEUTICALS AB
SE
Citalopram Bluefish 20 mg filmdragerade tabletter
NL/H/1601/002 42878 BLUEFISH PHARMACEUTICALS AB
SE
Citalopram Bluefish 40 mg filmdragerade tabletter
NL/H/1601/003 42879 BLUEFISH PHARMACEUTICALS AB
SE
CITALOPRAM BLUEFISH 20 mg, comprimé pelliculé sécable
NL/H/1601/002 34009 217 218 8 1 BLUEFISH PHARMACEUTICALS AB
FR
List of nationally authorised medicinal products EMA/583896/2017 Page 12/93
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
CITALOPRAM BLUEFISH 20 mg, comprimé pelliculé sécable
NL/H/1601/002 34009 217 219 4 2 BLUEFISH PHARMACEUTICALS AB
FR
CITALOPRAM BLUEFISH 20 mg, comprimé pelliculé sécable
NL/H/1601/002 34009 217 220 2 4 BLUEFISH PHARMACEUTICALS AB
FR
CITALOPRAM BLUEFISH 20 mg, comprimé pelliculé sécable
NL/H/1601/002 34009 580 858 6 4 BLUEFISH PHARMACEUTICALS AB
FR
Citalopram Bluefish 10 mg filmuhúðaðar töflur
NL/H/1601/001 IS/1/12/070/01 BLUEFISH PHARMACEUTICALS AB
IS
Citalopram Bluefish 20 mg filmuhúðaðar töflur
NL/H/1601/002 IS/1/12/070/02 BLUEFISH PHARMACEUTICALS AB
IS
Citalopram Bluefish 40 mg filmuhúðaðar töflur
NL/H/1601/003 IS/1/12/070/03 BLUEFISH PHARMACEUTICALS AB
IS
Pram 10 mg apvalkotās tabletes
not available 03-0197 G.L. PHARMA GMBH LV
Pram 20 mg apvalkotas tabletes
not available 03-0198 G.L. PHARMA GMBH LV
Pram 40 mg apvalkotas tabletes
not available 03-0199 G.L. PHARMA GMBH LV
CITALOPRAM DOC Generici 20 mg compresse rivestite con film
not available 036266017 DOC GENERICI S.R.L. IT
CITALOPRAM DOC Generici 40 mg compresse rivestite con film
not available 036266029 DOC GENERICI S.R.L. IT
PERCITALE 20 mg compresse rivestite con film
not available 036302026 PIAM FARMACEUTICI S.P.A. IT
PERCITALE 40 mg compresse rivestite con film
not available 036302038 PIAM FARMACEUTICI S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 13/93
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
PERCITALE 40 mg/ml gocce orali, soluzione
not available 036302014 PIAM FARMACEUTICI S.P.A. IT
Citalopram Actavis 10 mg filmdragerade tabletter
not available 17718 ACTAVIS NORDIC A/S SE
Citalopram Actavis 20 mg filmdragerade tabletter
not available 17719 ACTAVIS NORDIC A/S SE
Citalopram Actavis 40 mg filmdragerade tabletter
not available 17720 ACTAVIS NORDIC A/S SE
LOPRAXER®, επικαλυμμένa με λεπτό υμένιο δισκία, 20mg/tab
not available 2814/18-07-2013 HELP ABEE GR
LOPRAXER®, επικαλυμμένa με λεπτό υμένιο δισκία, 30mg/tab
not available 47337/18-07-2013 HELP ABEE GR
LOPRAXER®, επικαλυμμένa με λεπτό υμένιο δισκία, 40mg/tab
not available 47336/18-07-2013 HELP ABEE GR
LOPRAXER®, πόσιμες σταγόνες, διάλυμα, 40mg/ml
not available 2812/18-07-2013 HELP ABEE GR
CITALOPRAM EUROGENERICI 40 mg/ml gocce orali, soluzione
not available 036869016 EG S.P.A. IT
Zanipram: 40mg/ml πόσιμες σταγόνες, διάλυμα
not available 17537 VOCATE ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ GR
Zanipram: 20mg/Tab επικαλυμμένα με λεπτό υμένιο δισκία
not available 73556/12 VOCATE ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ GR
List of nationally authorised medicinal products EMA/583896/2017 Page 14/93
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
Zanipram: 40mg/Tab επικαλυμμένα με λεπτό υμένιο δισκία
not available 43383 VOCATE ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ GR
Zitolex 10 mg comprimidos revestidos por película
not available 5166202 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 10 mg comprimidos revestidos por película
not available 5166210 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 10 mg comprimidos revestidos por película
not available 5166228 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 10 mg comprimidos revestidos por película
not available 5166236 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 20 mg comprimidos revestidos por película
not available 5166251 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 20 mg comprimidos revestidos por película
not available 5166269 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 20 mg comprimidos revestidos por película
not available 5166277 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 20 mg comprimidos revestidos por película
not available 5166301 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 40 mg comprimidos revestidos por película
not available 5166327 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 40 mg comprimidos revestidos por película
not available 5166335 DECOMED FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 15/93
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
Zitolex 40 mg comprimidos revestidos por película
not available 5166343 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 40 mg comprimidos revestidos por película
not available 5166350 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 10 mg comprimidos revestidos por película
not available 5166178 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 20 mg comprimidos revestidos por película
not available 5166244 DECOMED FARMACÊUTICA, S.A.
PT
Zitolex 40 mg comprimidos revestidos por película
not available 5166319 DECOMED FARMACÊUTICA, S.A.
PT
Citalopram AbZ 10 mg Filmtabletten
DK/H/0752/001 62585.00.00 ABZ-PHARMA GMBH DE
Loxopram, filmovertrukne tabletter
DK/H/0752/001 34364 RATIOPHARM GMBH DK
Loxopram, filmovertrukne tabletter
DK/H/0752/002 34365 RATIOPHARM GMBH DK
Citalopram-ratiopharm 40 mg Filmtabletten
DK/H/0752/003 1-26033 RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH
AT
Loxopram, filmovertrukne tabletter
DK/H/0752/003 34366 RATIOPHARM GMBH DK
Citalopram-ratiopharm 20 mg filmomhulde tabletten
NL/H/0311/002 BE422021 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram-ratiopharm 20 mg Filmtabletten
NL/H/0311/002 BE422021 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram-ratiopharm 20 mg comprimés pelliculés
NL/H/0311/002 BE422021 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram-ratiopharm 20 mg Filmtabletten
NL/H/0311/002 BE239626 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/583896/2017 Page 16/93
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
Citalopram-ratiopharm 20 mg comprimés pelliculés
NL/H/0311/002 BE239626 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram-ratiopharm 20 mg Filmtabletten
NL/H/0311/002 BE239635 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram-ratiopharm 20 mg comprimés pelliculés
NL/H/0311/002 BE239635 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram-ratiopharm 40 mg filmdragerade tabletter
NL/H/0311/003 16863 RATIOPHARM GMBH FI
Citalopram-ratiopharm 20 mg filmdragerade tabletter
NL/H/0311/002 16862 RATIOPHARM GMBH FI
Citalopram-ratiopharm 10 mg filmdragerade tabletter
NL/H/0311/001 16861 RATIOPHARM GMBH FI
Citalopram-ratiopharm® 20 mg Filmtabletten
NL/H/0311/002 53072.01.00 RATIOPHARM GMBH DE
Citalopram-ratiopharm 20 mg Filmtabletten
NL/H/0311/002 1-24578 RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH
AT
Citalopram-ratiopharm 20 mg tabletti, kalvopäällysteinen
NL/H/0311/002 16862 RATIOPHARM GMBH FI
Citalopram-ratiopharm 10 mg tabletti, Kalvopäällysteinen
NL/H/0311/001 16861 RATIOPHARM GMBH FI
Citalopram-ratiopharm 40 mg tabletti, kalvopäällysteinen
NL/H/0311/003 16863 RATIOPHARM GMBH FI
Citalopram-ratiopharm 20 mg filmomhulde tabletten
NL/H/0311/002 BE239635 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram-ratiopharm® 10 mg Filmtabletten
NL/H/0311/001 53072.00.00 RATIOPHARM GMBH DE
List of nationally authorised medicinal products EMA/583896/2017 Page 17/93
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
Citalopram-ratiopharm® 40 mg Filmtabletten
NL/H/0311/003 53072.02.00 RATIOPHARM GMBH DE
Citalopram-ratiopharm 10 mg Filmtabletten
NL/H/0311/001 1-24577 RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH
AT
Citalopram-ratiopharm 20 mg filmomhulde tabletten
NL/H/0311/002 BE239626 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram ratiopharm 40 mg, filmomhulde tabletten
NL/H/0311/003 RVG 25152 RATIOPHARM NEDERLAND B.V
NL
Citalopram ratiopharm 20 mg, filmomhulde tabletten
NL/H/0311/002 RVG 25151 RATIOPHARM NEDERLAND B.V
NL
Citalopram ratiopharm 10 mg, filmomhulde tabletten
NL/H/0311/001 RVG 25150 RATIOPHARM NEDERLAND B.V
NL
Citalopram LAREQ 30 mg comprimidos recubiertos con película EFG
not available 66.279 APOTEX ESPAÑA, S.L. ES
Citalostad 10 mg Filmtabletten
not available 1-25315 STADA ARZNEIMITTEL GMBH
AT
Citalopram Davur 20 mg comprimidos recubiertos con película EFG
not available 66505 LABORATORIOS DAVUR S.L ES
Citalopram-CT 20 mg Filmtabletten
NL/H/0460/002 58938.01.00 ABZ-PHARMA GMBH DE
Citalopram 40 ct NL/H/0460/003 RVG 27620 TEVA PHARMA B.V. NL Citalopram-CT 40 mg Filmtabletten
NL/H/0460/003 58938.02.00 ABZ-PHARMA GMBH DE
Citalopram 20 ct, filmomhulde tabletten
NL/H/0460/002 RVG 27619 TEVA PHARMA B.V. NL
KAIDOR 40 mg/ml gocce orali, soluzione
not available 036246015 FARTO S.R.L. FARMACO BIOCHIMICO TOSCANO
IT
List of nationally authorised medicinal products EMA/583896/2017 Page 18/93
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
Citalopram Orifarm 10 mg filmdragerade tabletter
not available 19631 ORIFARM GENERICS A/S SE
Citalopram Orifarm 20 mg filmdragerade tabletter
not available 19632 ORIFARM GENERICS A/S SE
Citalopram Orifarm 30 mg filmdragerade tabletter
not available 19633 ORIFARM GENERICS A/S SE
Citalopram Orifarm 40 mg filmdragerade tabletter
not available 19634 ORIFARM GENERICS A/S SE
LINISAN 10 mg comprimate filmate
not available 7778/2006/01 GEDEON RICHTER ROMÂNIA S.A.
RO
LINISAN 20 mg comprimate filmate
not available 7779/2006/01 GEDEON RICHTER ROMÂNIA S.A.
RO
Pram 10 mg-Filmtabletten
not available 1-24597 G.L. PHARMA GMBH AT
Pram 20 mg-Filmtabletten
not available 1-24598 G.L. PHARMA GMBH AT
Pram 40 mg-Filmtabletten
not available 1-24599 G.L. PHARMA GMBH AT
CITALOPRAM NORMON 20 mg Comprimidos recubiertos con película EFG
not available 66795 LABORATORIOS NORMON, S.A.
ES
CITALOPRAM NORMON 30 mg Comprimidos recubiertos con película EFG
not available 66794 LABORATORIOS NORMON, S.A.
ES
Citalopram Ritisca 10 mg comprimidos revestidos por película
not available 5641840 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 19/93
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
Citalopram Ritisca 10 mg comprimidos revestidos por película
not available 5641857 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Ritisca 20 mg comprimidos revestidos por película
not available 5641865 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Ritisca 40 mg comprimidos revestidos por película
not available 5641873 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 5136460 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 5136478 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 5136502 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 5136510 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 5136544 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 5137633 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 5136551 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 20/93
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
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 DE/H/1164/001 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 21/93
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
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 DE/H/1164/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 DE/H/1164/04 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 DE/H/1164/04 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 DE/H/1164/04 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 DE/H/1164/04 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 DE/H/1164/04 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 DE/H/1164/04 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 DE/H/1164/04 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 22/93
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
Citalopram Ritisca 40 mg comprimidos revestidos por película
not available 14/H/0172/003 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Ritisca 40 mg comprimidos revestidos por película
not available 14/H/0172/003 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Ritisca 20 mg comprimidos revestidos por película
not available 14/H/0172/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Ritisca 20 mg comprimidos revestidos por película
not available 14/H/0172/002 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Ritisca 10 mg comprimidos revestidos por película
not available 14/H/0172/001 AUROVITAS UNIPESSOAL, LDA.
PT
CITALOPRAM AUROBINDO 40 mg/ml gocce orali, soluzione
not available 036675039 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
CITALOPRAM AUROBINDO 40 mg/ml gocce orali, soluzione
not available 036675039 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Citalopram Wynn 20 mg comprimidos revestidos por película
not available 5016803 AXONE, LDA. PT
Citalopram Wynn 40 mg comprimidos revestidos por película
not available 5016811 AXONE, LDA. PT
Citalopram Wynn 40 mg comprimidos revestidos por película
not available 5053830 AXONE, LDA. PT
Citalopram Wynn 20 mg comprimidos revestidos por película
not available 5016779 AXONE, LDA. PT
List of nationally authorised medicinal products EMA/583896/2017 Page 23/93
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
CITALOPRAM AUROBINDO ITALIA 20 mg compresse rivestite con film
not available 036660013 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
CITALOPRAM AUROBINDO ITALIA 40 mg compresse rivestite con film
not available 036660025 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
CITALOPRAM RANBAXY 20 mg, comprimé pelliculé sécable
not available NL 33233 RANBAXY PHARMACIE GENERIQUES
FR
VERUS® Αναβράζον δισκίο 20mg/tab
not available 42754/10 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
VERUS® Αναβράζον δισκίο 40mg/tab
not available 42745/10 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
VERUS® Επικαλυμμένα με λεπτό υμένιο δισκία 20mg/tab
not available 42746/10 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
VERUS® Επικαλυμμένο με λεπτό υμένιο δισκίο 40mg/tab
not available 42748/10 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
VERUS® Πόσιμες σταγόνες, διάλυμα 40mg/ml
not available 42762/10 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
VERUS® Πόσιμο διάλυμα σε συσκευασία μιας δόσης 16mg/5ml
not available 42743/10 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
CITALOPRAM EVOLUGEN 20 mg, comprimé pelliculé sécable
not available 34009 491 798 8 6 EVOLUPHARM FR
CITALOPRAM EVOLUGEN 20 mg, comprimé pelliculé sécable
not available 34009 498 910 8 5 EVOLUPHARM FR
List of nationally authorised medicinal products EMA/583896/2017 Page 24/93
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
CITALOPRAM EVOLUGEN 20 mg, comprimé pelliculé sécable
not available 34009 577 621 9 3 EVOLUPHARM FR
CITALOPRAM EVOLUGEN 20 mg, comprimé pelliculé sécable
not available 34009 578 944 6 7 EVOLUPHARM FR
Citalon® 20 mg Filmtabletten
DE/H/2904/001 55457.00.00 KREWEL MEUSELBACH GMBH
DE
Citalon® 40 mg Filmtabletten
DE/H/2904/002 55457.02.00 KREWEL MEUSELBACH GMBH
DE
Malicon® not available 34107/12/08-03-2013 NORMA HELLAS S.A. GR Malicon® not available 19169/08-03-2013 NORMA HELLAS S.A. GR Citalopram GERMED Pharma 20 mg compresse rivestite con film
not available 036482014 GERMED PHARMA S.R.L. IT
Citalopram GERMED PHARMA 40 mg compresse rivestite con film
not available 036482026 GERMED PHARMA S.R.L. IT
Citalopram GERMED PHARMA 40 mg/ml concentrato per soluzione per infusione
not available 036482038 GERMED PHARMA S.R.L. IT
Citalopram GERMED Pharma 40 mg/ml gocce orali, soluzione
not available 036482040 GERMED PHARMA S.R.L. IT
Citalopram MABO 10 mg comprimidos recubiertos con película
not available 66.249 MABO-FARMA, S.A. ES
Citalopram MABO 20 mg comprimidos recubiertos con película EFG
not available 66.251 MABO-FARMA, S.A. ES
List of nationally authorised medicinal products EMA/583896/2017 Page 25/93
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
Citalopram ARISTO 20 mg comprimidos recubiertos con película EFG
not available 66231 ARISTO PHARMA IBERIA, S.L.
ES
Citalopram Aristo 30 mg comprimidos recubiertos con película EFG
not available 66229 ARISTO PHARMA IBERIA, S.L.
ES
Citalopram Farmalider 10 mg comprimidos recubiertos con película
not available 66.346 FARMALIDER, S.A. ES
PRALOTAM not available 106197/14/06-04-2015 VENIFAR LTD GR PRALOTAM not available 21927/06-04-2015 VENIFAR LTD GR Citalopram Kern Pharma 20 mg comprimidos recubiertos con película EFG
not available 65.977 KERN PHARMA, S.L. ES
Citalopram Kern Pharma 30 mg comprimidos recubiertos con película EFG
not available 65.993 KERN PHARMA, S.L. ES
Cital, 20 mg, tabletki powlekane
not available 8955 GLENMARK PHARMACEUTICALS S.R.O.
PL
Citalopram Ranbaxygen 20 mg comprimidos recubiertos con película
UK/H/0672/002 67107 LABORATORIOS RANBAXY S.L.
ES
CITALOPRAM BASICS 10 mg Filmtabletten
UK/H/0672/001 60782.00.00 BASICS GMBH DE
CITALOPRAM BASICS 20 mg Filmtabletten
UK/H/0672/002 60782.01.00 BASICS GMBH DE
CITALOPRAM BASICS 40 mg Filmtabletten
UK/H/0672/003 60782.02.00 BASICS GMBH DE
Citalopram EG 20 mg Filmtabletten
NL/H/0310/002 BE239513 EUROGENERICS N.V./S.A. BE
Citalopram EG 20 mg Filmtabletten
NL/H/0310/002 BE239522 EUROGENERICS N.V./S.A. BE
List of nationally authorised medicinal products EMA/583896/2017 Page 26/93
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
Citalopram EG 20 mg filmomhulde tabletten
NL/H/0310/002 BE239513 EUROGENERICS N.V./S.A. BE
Citalopram EG 20 mg filmomhulde tabletten
NL/H/0310/002 BE239522 EUROGENERICS N.V./S.A. BE
Citalopram EG 20 mg comprimés pelliculés
NL/H/0310/002 BE239522 EUROGENERICS N.V./S.A. BE
Citalopram EG 20 mg comprimés pelliculés
NL/H/0310/002 BE239513 EUROGENERICS N.V./S.A. BE
Citalopram CF 40 mg, filmomhulde tabletten
NL/H/0310/003 RVG 25149 CENTRAFARM B.V. NL
Citalopram CF 20 mg, filmomhulde tabletten
NL/H/0310/002 RVG 25148 CENTRAFARM B.V. NL
Citalopram CF 10 mg, filmomhulde tabletten
NL/H/0310/001 RVG 25147 CENTRAFARM B.V. NL
Citalopram CF 30 mg, filmomhulde tabletten
NL/H/0310/004 RVG 31114 CENTRAFARM B.V. NL
APO-CITAL 20 mg potahované tablety
CZ/H/0182/001 30/210/07-C APOTEX EUROPE BV CZ
Citalopram Apotex 20 mg, filmomhulde tabletten
CZ/H/0182/001 RVG 34746 APOTEX EUROPE B.V. NL
Citalopram Apotex 40 mg, filmomhulde tabletten
CZ/H/0182/002 RVG 34747 APOTEX EUROPE B.V. NL
Citalopram Apotex 20 mg comprimidos recubiertos con película EFG
CZ/H/0182/001 70250 APOTEX EUROPE BV ES
Citalopram Apotex 40 mg comprimidos recubiertos con película EFG
CZ/H/0182/002 70249 APOTEX EUROPE BV ES
SEROR 20mg επικαλυμμένα με λεπτό υμένιο δισκία.
not available 20301/17-10-2012 SPECIFAR S.A. GR
List of nationally authorised medicinal products EMA/583896/2017 Page 27/93
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
SEROR 40mg επικαλυμμένα με λεπτό υμένιο δισκία
not available 72413/17-10-2012 SPECIFAR S.A. GR
CITALOPRAM ACTAVIS 20 mg, comprimé pelliculé sécable
not available NL 38302 ACTAVIS GROUP PTC EHF. FR
Citalopram PENSA 20 mg compresse rivestite con film
not available 036392013 PENSA PHARMA S.P.A. IT
Citalopram Pensa 20 mg compresse rivestite con film
not available 036392025 PENSA PHARMA S.P.A. IT
Citalopram Pensa Pharma 40 mg/ml gocce orali, soluzione
not available 038199016 PENSA PHARMA S.P.A. IT
Citalopram PENSA 40 mg compresse rivestite con film
not available 036392037 PENSA PHARMA S.P.A. IT
CITALOPRAM PENSA 10 mg comprimidos recubiertos con película
not available 68.394 PENSA PHARMA, S.A ES
CITALOPRAM PENSA 20 mg Comprimidos recubiertos con película EFG
not available 68.395 PENSA PHARMA, S.A ES
CITALOPRAM PENSA 30 mg Comprimidos recubiertos con película EFG
not available 68.396 PENSA PHARMA, S.A ES
Citalopram Hennig® 20 mg Filmtabletten
not available 54076.01.00 HENNIG ARZNEIMITTEL GMBH & CO. KG
DE
Citacip, filmovertrukne tabletter
DK/H/0750/003 34363 STADA ARZNEIMITTEL AG DK
Citacip, filmovertrukne tabletter
DK/H/0750/002 34362 STADA ARZNEIMITTEL AG DK
List of nationally authorised medicinal products EMA/583896/2017 Page 28/93
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
Citacip, filmovertrukne tabletter
DK/H/0750/001 34361 STADA ARZNEIMITTEL AG DK
Citalopram STADA 10 mg filmtabletta
DK/H/0750/001 OGYI-T-10391/01 STADA ARZNEIMITTEL AG HU
Citalopram STADA® 20 mg Filmtabletten
DK/H/0750/002 62579.01.00 STADAPHARM GMBH DE
Citalopram STADA® 40 mg Filmtabletten
DK/H/0750/003 62579.02.00 STADAPHARM GMBH DE
Citalopram STADA® 10 mg Filmtabletten
DK/H/0750/001 62579.00.00 STADAPHARM GMBH DE
Citalopram STADA 20 mg filmtabletta
DK/H/0750/002 OGYI-T-10391/02 STADA ARZNEIMITTEL AG HU
Citalopram STADA 40 mg filmtabletta
DK/H/0750/003 OGYI-T-10391/03 STADA ARZNEIMITTEL AG HU
CITALOPRAM MOLTENI 40 mg compresse rivestite con film
not available 035976036 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
CITALOPRAM MOLTENI 20 mg compresse rivestite con film
not available 035976012 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
CITALOPRAM MOLTENI 20 mg compresse rivestite con film
not available 035976024 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Citalopram Alternova, filmovertrukne tabletter
not available 36152 ALTERNOVA A/S DK
ОРОПРАМ 20 MG ФИЛМИРАНИ ТАБЛЕТКИ
not available 20030535 ACTAVIS EAD BG
Citalopram 40 mg film-coated tablets
not available PL 20532/0043 AUROBINDO PHARMA LIMITED
UK
Citalopram 10 mg film-coated tablets
not available PL 20532/0041 AUROBINDO PHARMA LIMITED
UK
Citalopram 20 mg film-coated tablets
not available PL 20532/0042 AUROBINDO PHARMA LIMITED
UK
List of nationally authorised medicinal products EMA/583896/2017 Page 29/93
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
CITALOPRAM TEVA SANTE 20 mg, comprimé pelliculé sécable
not available FR NL27598 TEVA SANTÉ DE
Citalopram beta 20 mg Filmtabletten
not available 66055.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Citalopram beta 30 mg Filmtabletten
not available 70754.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Citalopram beta 40 mg Filmtabletten
not available 66056.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Citalopram Aristo® 10 mg Filmtabletten
not available 66057.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Citalopram Aristo® 20 mg Filmtabletten
not available 66058.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Citalopram Aristo® 30 mg Filmtabletten
not available 70629.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Citalopram Aristo® 40 mg Filmtabletten
not available 66059.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Acelopam Πόσιμες σταγόνες, διάλυμα 40mg/ml
not available 53774 PHERAKON PC GR
Citalopram ratiopharm 30 mg comprimidos recubiertos con película EFG
not available 66.267 RATIOPHARM ESPANA SA ES
Citalopram ratiopharm 10 mg comprimidos recubiertos con película
not available 66264 RATIOPHARM ESPANA SA ES
Unstress, Oral solution 40mg / ml
not available 41683/12 HEREMCO GR
Zyloram tablety 20 mg filmom obalené tablety
not available 30/0122/04-S RANBAXY (UK) LIMITED SK
Citalopram STADA® 30 mg Filmtabletten
not available 70627.00.00 STADAPHARM GMBH DE
Citalopram 40mg Tablets not available PL 44041/0010 NOUMED LIFE SCIENCES UK Citalopram 20mg Tablets not available PL 44041/0009 NOUMED LIFE SCIENCES UK
List of nationally authorised medicinal products EMA/583896/2017 Page 30/93
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
Citalopram 10mg Tablets not available PL 44041/0008 NOUMED LIFE SCIENCES UK CIPRANED Επικαλυμμένο με λεπτό υμένιο δισκίο, 20 mg/tab
not available 74530/14/06-05-2015 MEDICAL PHARMAQUALITY PHARMACEUTICALS S.A.
GR
CIPRANED Επικαλυμμένο με λεπτό υμένιο δισκίο, 40 mg/tab
not available 30791/06-05-2015 MEDICAL PHARMAQUALITY PHARMACEUTICALS S.A.
GR
VESEMA® not available 47382/11 PHARMEX S.A. GR VESEMA® not available 47383/11 PHARMEX S.A. GR RENEVIL not available 26687/12 PHARMANEL COMMERCIAL
PHARMACEUTICAL S.A. GR
RENEVIL not available 43377/04-06-2013 PHARMANEL COMMERCIAL PHARMACEUTICAL S.A.
GR
RENEVIL not available 43377/04-06-2013 PHARMANEL COMMERCIAL PHARMACEUTICAL S.A.
GR
RETURN 20 mg compresse rivestite con film
not available 036792012 EURO-PHARMA S.R.L. IT
RETURN 40 mg/ml gocce orali, soluzione
not available 036792036 EURO-PHARMA S.R.L. IT
SOTOVON 40mg/ML not available 37619/10 BROS LTD GR CITALOPRAM ZYDUS 20 mg, comprimé pelliculé sécable
not available 34009 388 171 6 4 ZYDUS FRANCE FR
PRAM 20 mg Potahované tablety
not available 30/109/04-C G.L. PHARMA GMBH CZ
Oropram 10mg filmuhúðaðar töflur
not available 990322 ACTAVIS HF. IS
Oropram 20 mg filmuhúðaðar töflur
not available 990323 ACTAVIS HF. IS
Oropram 40mg filmuhúðaðar töflur
not available 990324 ACTAVIS HF. IS
Citalonte, filmovertrukne tabletter
DK/H/0751/001 34358 STADA ARZNEIMITTEL AG DK
List of nationally authorised medicinal products EMA/583896/2017 Page 31/93
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
Citalonte, filmovertrukne tabletter
DK/H/0751/002 34359 STADA ARZNEIMITTEL AG DK
Citalonte, filmovertrukne tabletter
DK/H/0751/003 34360 STADA ARZNEIMITTEL AG DK
Citalopram AL 40 mg Filmtabletten
DK/H/0751/003 62582.02.00 ALIUD PHARMA GMBH DE
Citalopram AL 20 mg Filmtabletten
DK/H/0751/002 62582.01.00 ALIUD PHARMA GMBH DE
Citalopram AL 10 mg Filmtabletten
DK/H/0751/001 62582.00.00 ALIUD PHARMA GMBH DE
Citalopram Davur 30 mg comprimidos recubiertos con película EFG
not available 67581 LABORATORIOS DAVUR S.L ES
Citalopram EG 40 mg comprimés pelliculés
NL/H/0465/003 0019/06010040 EUROGENERICS SA LU
Citalopram EG 10 mg comprimés pelliculés
NL/H/0465/001 0019/06010038 EUROGENERICS SA LU
Citalopram EG 20 mg comprimés pelliculés
NL/H/0465/002 0019/07069352 EUROGENERICS SA LU
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503112 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503175 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503201 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503098 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503213 EG S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 32/93
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
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503011 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503249 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503163 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503050 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503136 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503187 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503047 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503062 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503124 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503148 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503074 EG S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 33/93
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
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503086 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503100 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503237 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503035 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503151 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503225 EG S.P.A. IT
CITALOPRAM EG 40 mg compresse rivestite con film
NL/H/0465/003 036503199 EG S.P.A. IT
CITALOPRAM EG 20 mg compresse rivestite con film
NL/H/0465/002 036503023 EG S.P.A. IT
Citalopram ”PCD”, filmovertrukne tabletter
NL/H/0465/001 35967 PHARMACODANE APS DK
Citalopram ”PCD”, filmovertrukne tabletter
NL/H/0465/002 35968 PHARMACODANE APS DK
CITALOPRAM STADA 20 mg, filmomhulde tabletten
NL/H/0465/002 RVG 27634 STADA ARZNEIMITTEL AG NL
Citalopram ”PCD”, filmovertrukne tabletter
NL/H/0465/003 35969 PHARMACODANE APS DK
List of nationally authorised medicinal products EMA/583896/2017 Page 34/93
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
Citalopram STADA 40 mg, filmomhulde tabletten
NL/H/0465/003 RVG 27635 STADA ARZNEIMITTEL AG NL
Ciprotan 10 mg film-coated tablets
NL/H/0465/001 PA0126/131/001 CLONMEL HEALTHCARE LTD. IE
CITALOPRAM STADA 10 mg, filmomhulde tabletten
NL/H/0465/001 RVG 27633 STADA ARZNEIMITTEL AG NL
Citalopram STADA 30 mg, filmomhulde tabletten
NL/H/0465/004 RVG 31380 STADA ARZNEIMITTEL AG NL
Ciprotan 20 mg film-coated tablets
NL/H/0465/002 PA0126/131/002 CLONMEL HEALTHCARE LTD. IE
Citalopram +pharma 20 mg Filmtabletten
AT/H/0436/002 1-26447 +PHARMA ARZNEIMITTEL GMBH
AT
Citalopram +pharma 40 mg Filmtabletten
AT/H/0436/003 1-26448 +PHARMA ARZNEIMITTEL GMBH
AT
Citalopram Actavis 10 mg Film-coated Tablets
not available PA 1380/27/1 ACTAVIS GROUP PTC EHF. IE
Citalopram Actavis 20 mg Film-coated Tablets
not available PA 1380/27/2 ACTAVIS GROUP PTC EHF. IE
Citalopram 10mg Tablets not available PL 04077/0214 M&A PHARMACHEM LTD UK CITALOPRAM 20MG TABLETS
not available PL 04077/0215 M&A PHARMACHEM LTD UK
Citalopram 40mg Tablets not available PL 04077/0216 M&A PHARMACHEM LTD UK Citalopram-ratiopharm® 30 mg Filmtabletten
DE/H/2421/001 64641.00.00 RATIOPHARM GMBH DE
SINTOPRAM 40 mg/ml gocce orali, soluzione
not available 036327017 BIOMEDICA FOSCAMA GROUP S.P.A.
IT
citalopram cinfa 20 mg comprimidos recubiertos con película EFG
not available 67.804 LABORATORIOS CINFA, S.A. ES
GALOPRAN not available 24190/13 GALENUS PHARMACEUTICALS SA
GR
List of nationally authorised medicinal products EMA/583896/2017 Page 35/93
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
GALOPRAN not available 24191/13 GALENUS PHARMACEUTICALS SA
GR
PRAMITAL not available 19412 ANFARM HELLAS SA GR PRAMITAL not available 59181/12 ANFARM HELLAS SA GR Citalopram-neuraxpharm 10 mg Filmtabletten
DE/H/0776/001 53078.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Citalopram-neuraxpharm 20 mg Filmtabletten
DE/H/0776/002 53078.01.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Citalopram-neuraxpharm 40 mg Filmtabletten
DE/H/0776/003 53078.02.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
PRICITAL not available 40060/11-9-2008 LAVIPHARM HELLAS AE GR CITALOPRAM ALMUS 20 mg, comprimé pelliculé sécable
not available 3400936477131 BIOGARAN FR
CITALOPRAM ABC 20 mg compresse rivestite con film
not available 036043026 ABC FARMACEUTICI S.P.A. IT
CITALOPRAM ABC 40 mg compresse rivestite con film
not available 036043038 ABC FARMACEUTICI S.P.A. IT
CITALOPRAM ABC 40 mg/ml gocce orali, soluzione
not available 036043014 ABC FARMACEUTICI S.P.A. IT
Citalopram 10mg Tablets not available PL 21880/0060 MEDREICH PLC UK Citalopram 20mg Tablets not available PL 21880/0061 MEDREICH PLC UK Citalopram 40mg Tablets not available PL 21880/0062 MEDREICH PLC UK Citalopram Sandoz 10 mg tabletter, filmdrasjerte
DK/H/0575/001 04-2675 SANDOZ A/S NO
Citalopram Sandoz 40 mg tabletter, filmdrasjerte
DK/H/0575/004 04-2678 SANDOZ A/S NO
List of nationally authorised medicinal products EMA/583896/2017 Page 36/93
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
Citalopram Sandoz 20 mg tabletter, filmdrasjerte
DK/H/0575/002 04-2676 SANDOZ A/S NO
Citalon 20 mg filmom obložene tablete
HR-H-322905718 SANDOZ D.O.O. HR
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/013 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/014 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/015 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/016 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/017 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/018 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/019 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/020 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/024 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/023 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/021 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/025 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/026 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/027 SANDOZ GMBH SI
List of nationally authorised medicinal products EMA/583896/2017 Page 37/93
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
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/028 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/029 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/030 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/031 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/032 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/033 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/034 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/035 SANDOZ GMBH SI
Citalon 40 mg filmsko obložene tablete
NL/H/0308/003 H/04/00394/036 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/001 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/002 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/003 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/004 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/005 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/006 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/007 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/008 SANDOZ GMBH SI
List of nationally authorised medicinal products EMA/583896/2017 Page 38/93
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
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/009 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/010 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/011 SANDOZ GMBH SI
Citalon 10 mg filmsko obložene tablete
NL/H/0308/001 H/04/00394/012 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/022 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/013 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/014 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/015 SANDOZ GMBH SI
Citalon 20 mg filmsko obložene tablete
NL/H/0308/002 H/04/00394/016 SANDOZ GMBH SI
Citalon 10 mg NL/H/0308/001 30/018/05-C SANDOZ GMBH CZ Citalon 20 mg NL/H/0308/002 30/019/05-C SANDOZ GMBH CZ CITALOPRAM HEXAL AG 036662 036662017 HEXAL AG IT CITALOPRAM Sandoz GmbH 40 mg/ml gocce orali, soluzione
not available 036039016 SANDOZ GMBH IT
Citalopram 10 mg Tablets
NL/H/0308/001 PL 04416/0419 SANDOZ LTD UK
Citalopram 20 mg Tablets
NL/H/0308/002 PL 04416/0420 SANDOZ LTD UK
Citalopram 40 mg Tablets
NL/H/0308/003 PL 04416/0421 SANDOZ LTD UK
Citalopram Sandoz 20 mg Filmtabletten
DK/H/0576/002 59370.00.00 HEXAL AG DE
List of nationally authorised medicinal products EMA/583896/2017 Page 39/93
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
Citalopram - 1 A Pharma® 20 mg Filmtabletten
DK/H/0577/002 59374.01.00 1 A PHARMA GMBH DE
AUREX 40 40 MG, TABLETKI POWLEKANE
10535 10535 SANDOZ GMBH PL
Citalopram HEXAL® 10 mg Filmtabletten
DK/H/0575/001 59364.00.00 HEXAL AG DE
Citalopram HEXAL® 30 mg Filmtabletten
DK/H/0575/003 59364.02.00 HEXAL AG DE
Citalopram HEXAL 30 mg Filmtabletten
DK/H/0575/003 0715/06030002 HEXAL AG LU
Citalopram HEXAL 40 mg Filmtabletten
DK/H/0575/004 59364.03.00 HEXAL AG LU
Citalopram Sandoz 30 mg Filmtabletten
DK/H/0576/003 59370.01.00 HEXAL AG DE
Citalopram Sandoz 10 mg Filmtabletten
DK/H/0576/001 59369.00.00 HEXAL AG DE
Citalopram - 1 A Pharma® 30 mg Filmtabletten
DK/H/0577/003 59374.02.00 1 A PHARMA GMBH DE
Citalopram - 1 A Pharma® 40 mg Filmtabletten
DK/H/0577/004 59374.03.00 1 A PHARMA GMBH DE
AUREX 20 20 mg, tabletki powlekane
not available 10534 SANDOZ GMBH PL
Citalopram - 1 A Pharma® 10 mg Filmtabletten
DK/H/0577/001 59374.00.00 1 A PHARMA GMBH DE
Citalopram Sandoz 20 mg - Filmtabletten
NL/H/0308/002 1-24563 SANDOZ GMBH AT
Citalopram Sandoz 10 mg - Filmtabletten
NL/H/0308/001 1-24561 SANDOZ GMBH AT
Citalopram 1A Pharma 20 mg - Filmtabletten
945.527 1-24735 1A PHARMA GMBH AT
List of nationally authorised medicinal products EMA/583896/2017 Page 40/93
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
CITALOPRAM SANDOZ 20 mg, comprimé pelliculé sécable
not available 363 943-5 SANDOZ FR
CITALOPRAM SANDOZ 20 mg, comprimé pelliculé sécable
not available 363 944-1 SANDOZ FR
CITALOPRAM SANDOZ 20 mg, comprimé pelliculé sécable
NL 27809 363 945-8 SANDOZ FR
CITALOPRAM SANDOZ 20 mg, comprimé pelliculé sécable
not available 363 946-4 SANDOZ FR
CITALOPRAM SANDOZ 20 mg, comprimé pelliculé sécable
not available 565 175-9 SANDOZ FR
CITALOPRAM SANDOZ 20 mg, comprimé pelliculé sécable
not available 565 176-5 SANDOZ FR
Citapram 20 mg filmtabletta
NOT APPLICABLE OGYI-T-8976/01 SANDOZ HUNGÁRIA KFT HU
Citapram 30 mg filmtabletta
NOT APPLICABLE OGYI-T-8976/02 SANDOZ HUNGÁRIA KFT HU
Citapram 40 mg filmtabletta
NOT APPLICABLE OGYI-T-8976/03 SANDOZ HUNGÁRIA KFT HU
Citalopram Hexal 30 mg - Filmtabletten
NL/H/0366/002 1-24900 HEXAL PHARMA GMBH AT
Citalopram Hexal 40 mg - Filmtabletten
NL/H/0366/003 1-24901 HEXAL PHARMA GMBH AT
Citalopram Hexal 20 mg - Filmtabletten
NL/H/0366/001 1-24899 HEXAL PHARMA GMBH AT
CITALON 20 mg NL/H/0308/002 30/0254/04-S SANDOZ GMBH SK Ciral 20 mg NOT APPLICABLE 417503 SANDOZ PHARMACEUTICALS
D.D. EE
List of nationally authorised medicinal products EMA/583896/2017 Page 41/93
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
CITALOPRAM SANDOZ 20, filmomhulde tabletten 20 mg
NL/H/0308/002 RVG 25142 SANDOZ B.V. NL
CITALOPRAM SANDOZ 10, filmomhulde tabletten 10 mg
NL/H/0308/001 RVG 25141 SANDOZ B.V. NL
CITALOPRAM SANDOZ 40, filmomhulde tabletten 40 mg
NL/H/0308/003 RVG 25143 SANDOZ B.V. NL
Citalopram Sandoz 20 mg, filmomhulde tabletten
NL/H/0366/001 RVG 26734 SANDOZ B.V. NL
Citalopram Sandoz 30 mg, filmomhulde tabletten
NL/H/0366/002 RVG 26735 SANDOZ B.V. NL
Citalopram Sandoz 40 mg, filmomhulde tabletten
NL/H/0366/003 RVG 26736 SANDOZ B.V. NL
Citalopram ”Sandoz”, filmovertrukne tabletter
DK/H/0576/003 34596 SANDOZ A/S DK
Citalopram ”Sandoz”, filmovertrukne tabletter
DK/H/0576/002 34595 SANDOZ A/S DK
Citalopram "1A Farma" DK/H/0577/001 34425 1A FARMA A/S DK Citalopram ”Sandoz”, filmovertrukne tabletter
DK/H/0576/004 34597 SANDOZ A/S DK
Citalopram ”Sandoz”, filmovertrukne tabletter
DK/H/0576/001 34424 SANDOZ A/S DK
Citalopram "1A Farma", filmovertrukne tabletter
DK/H/0577/003 32868 1A FARMA A/S DK
Citalopram "1A Farma", filmovertrukne tabletter
DK/H/0577/004 32869 1A FARMA A/S DK
Citalopram "1A Farma", filmovertrukne tabletter
DK/H/0577/002 32867 1A FARMA A/S DK
List of nationally authorised medicinal products EMA/583896/2017 Page 42/93
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
Citalopram Sandoz 10 mg filmdragerade tabletter
DK/H/0575/001 21044 SANDOZ A/S SE
Citalopram Sandoz 20 mg filmdragerade tabletter
DK/H/0575/002 21045 SANDOZ A/S SE
Citalopram Sandoz 30 mg filmdragerade tabletter
DK/H/0575/003 21046 SANDOZ A/S SE
Citalopram Sandoz 40 mg filmdragerade tabletter
DK/H/0575/004 21047 SANDOZ A/S SE
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238198 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238200 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238236 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238251 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238275 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238299 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238301 SANDOZ B.V. IT
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367340/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367353/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367365/M SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 43/93
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
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367377/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367415/M SANDOZ S.P.A. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238212 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238174 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238186 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238224 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238287 SANDOZ B.V. IT
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367403/M SANDOZ S.P.A. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238263 SANDOZ B.V. IT
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367389/M SANDOZ S.P.A. IT
CITALOPRAM SANDOZ BV
SE/H/1641/004 038238248 SANDOZ B.V. IT
CITALOPRAM HEXAL 40 mg, compresse rivestite con film
NL/H/0366/003 036367391/M SANDOZ S.P.A. IT
Citalopram Sandoz 20 mg, filmomhulde tabletten
NL/H/0366/001 BE 255936 SANDOZ N.V. BE
Citalopram Sandoz 20 mg, filmomhulde tabletten
NL/H/0366/001 BE 363054 SANDOZ N.V. BE
List of nationally authorised medicinal products EMA/583896/2017 Page 44/93
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
Citalopram Sandoz 40 mg, filmomhulde tabletten
NL/H/0366/003 BE363063 SANDOZ N.V. BE
Citalopram Sandoz 30 mg, filmomhulde tabletten
NL/H/0366/002 BE255911 SANDOZ N.V. BE
Citalopram Sandoz 40 mg, filmomhulde tabletten
NL/H/0366/003 BE255945 SANDOZ N.V. BE
Citalopram HEXAL® 20 mg Filmtabletten
DK/H/0575/002 59364.01.00 HEXAL AG DE
Citalopram HEXAL® 40 mg Filmtabletten
DK/H/0575/004 59364.03.00 HEXAL AG DE
Citalopram Sandoz 40 mg Filmtabletten
DK/H/0576/004 59370.02.00 HEXAL AG DE
Ciral 20 mg plėvele dengtos tabletės
not available LT/1/03/2246/002 SANDOZ PHARMACEUTICALS D.D.
LT
Ciral 20 mg plėvele dengtos tabletės
not available LT/1/03/2246/001 SANDOZ PHARMACEUTICALS D.D.
LT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238022 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238010 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238059 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238034 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238061 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238109 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238046 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238073 SANDOZ B.V. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 45/93
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
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238085 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238097 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238123 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238111 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238150 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238135 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238147 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238313 SANDOZ B.V. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367124/M SANDOZ S.P.A. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238162 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238325 SANDOZ B.V. IT
CITALOPRAM SANDOZ BV
SE/H/1641/002 038238337 SANDOZ B.V. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367148/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367136/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367163/M SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 46/93
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
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367175/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367151/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367187/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367225/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367201/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367199/M SANDOZ S.P.A. IT
CITALOPRAM HEXAL 20 mg, compresse rivestite con film
NL/H/0366/001 036367213/M SANDOZ S.P.A. IT
Citalopram HEXAL 20 mg Filmtabletten
DK/H/0575/002 0715/06030001 HEXAL AG LU
Citalopram Sandoz 40 mg - Filmtabletten
NL/H/0308/003 1-25730 SANDOZ GMBH AT
Ciral 40 mg plėvele dengtos tabletės
not available LT/1/03/2246/003 SANDOZ PHARMACEUTICALS D.D.
LT
Citalopram 20mg Tablets NL/H/0366/001 PL 04416/0914 SANDOZ LTD UK Citalopram 10mg Tablets DK/H/0575/001 PL 04416/0913 SANDOZ LTD UK Citalopram 40mg Tablets NL/H/0366/003 PL 04416/0978 SANDOZ LTD UK CITALOPRAM BEXAL 20 mg comprimidos recubiertos con película EFG
NOT APPLICABLE 66.483 BEXAL FARMACÉUTICA S.A. ES
List of nationally authorised medicinal products EMA/583896/2017 Page 47/93
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
CITALOPRAM BEXAL 30 mg comprimidos recubiertos con película EFG
NOT APPLICABLE 65.994 BEXAL FARMACÉUTICA S.A. ES
Citalopram Sandoz 30 mg comprimidos recubiertos con película EFG
not available 66.119 SANDOZ FARMACÉUTICA, S.A.
ES
Citalopram Sandoz 20 mg comprimidos recubiertos con película EFG
NOT APPLICABLE 66.120 SANDOZ FARMACÉUTICA, S.A.
ES
CITROL 10mg Film-Coated Tablets
DK/H/0575/001 PA 711/64/1 ROWEX LTD IE
CITROL 20mg Film-Coated Tablets
DK/H/0575/002 PA 711/64/2 ROWEX LTD IE
CITROL 30mg Film-Coated Tablets
DK/H/0575/003 PA 711/64/3 ROWEX LTD IE
APO-CITAL 20 mg potahované tablety
CZ/H/0182/001 30/210/07-C APOTEX EUROPE BV CZ
Citalopram Apotex 20 mg, filmomhulde tabletten
CZ/H/0182/001 RVG 34746 APOTEX EUROPE B.V. NL
Citalopram Apotex 40 mg, filmomhulde tabletten
CZ/H/0182/002 RVG 34747 APOTEX EUROPE B.V. NL
Citalopram Apotex 20 mg comprimidos recubiertos con película EFG
CZ/H/0182/001 70250 APOTEX EUROPE BV ES
Citalopram Apotex 40 mg comprimidos recubiertos con película EFG
CZ/H/0182/002 70249 APOTEX EUROPE BV ES
List of nationally authorised medicinal products EMA/583896/2017 Page 48/93
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
OROPRAM 20MG FILM-COATED TABLETS.
not available MA155/01401 ACTAVIS HF. MT
Citalopram Heumann 10 mg Filmtabletten
- 59743.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Citalopram Heumann 20 mg Filmtabletten
- 78443.00.00
HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Citalopram Heumann 30 mg Filmtabletten
- 70625.00.00
HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Citalopram Heumann 40 mg Filmtabletten
- 78444.00.00
HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Citalopram 20 mg Holsten
not available 59744.00.00 HOLSTEN PHARMA GMBH DE
FELIPRAM 20 mg compresse rivestite con film
not available 036125019 S.F. GROUP SRL IT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/034 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/031 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/032 TEVA PHARMA B.V. LT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/033 TEVA PHARMA B.V. LT
Citalopram Teva 20 mg filmomhulde tabletten
NL/H/0692/002 BE292311 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram Teva 40 mg filmomhulde tabletten
NL/H/0692/003 BE292327 TEVA PHARMA BELGIUM N.V./S.A
BE
CITALOPRAM TEVA 10 mg FILMTABLETTEN
NL/H/0692/001 BE292302 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram Teva 40 mg Filmtabletten
NL/H/0692/003 BE292327 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram Teva 10 mg filmomhulde tabletten
NL/H/0692/001 BE292302 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/583896/2017 Page 49/93
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
CITALOPRAM TEVA 20 mg FILMTABLETTEN
NL/H/0692/002 BE292311 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram - Teva 40 mg NL/H/0692/003 30/0181/06-S TEVA PHARMACEUTICALS CR, S.R.O.
SK
Citalopram Teva 40 mg filmdrasjerte tabletter
NL/H/0692/003 05-3732 TEVA SWEDEN AB NO
Citalopram Teva 10 mg filmdrasjerte tabletter
NL/H/0692/001 05-3730 TEVA SWEDEN AB NO
Citalopram Teva 20 mg filmdrasjerte tabletter
NL/H/0692/002 05-3731 TEVA SWEDEN AB NO
Citalopram ”Teva”, filmovertrukne tabletter
NL/H/0692/002 38639 TEVA DENMARK A/S DK
Citalopram-Teva 40 mg potahované tablet
NL/H/0692/003 30/123/06-C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
Citalopram ”Teva”, filmovertrukne tabletter
NL/H/0692/003 38640 TEVA DENMARK A/S DK
Citalopram Teva 20 mg comprimés pelliculés
NL/H/0692/002 BE292311 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram Teva 40 mg comprimés pelliculés
NL/H/0692/003 BE292327 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram Teva 40mg Film-coated Tablets
NL/H/0692/003 PA 749/19/3 TEVA PHARMA B.V. IE
Citalopram 20mg film-coated tablets
NL/H/0692/002 PL 00289/0928 TEVA UK LIMITED UK
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/026 TEVA PHARMA B.V. LT
Citalopram 40mg film-coated tablets
NL/H/0692/003 PL 00289/0929 TEVA UK LIMITED UK
Citalopram-Teva 40 mg, õhukese polümeerikattega tabletid
NL/H/0692/003 512906 TEVA PHARMA B.V. EE
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/021 TEVA PHARMA B.V. LT
List of nationally authorised medicinal products EMA/583896/2017 Page 50/93
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
Citalopram Teva 10 mg comprimés pelliculés
NL/H/0692/001 BE292302 TEVA PHARMA BELGIUM N.V./S.A
BE
Citalopram Teva 40 mg filmdragerade tabletter
NL/H/0692/003 23002 TEVA SWEDEN AB SE
Citalopram - Teva 10 mg NL/H/0692/001 30/0179/06-S TEVA PHARMACEUTICALS CR, S.R.O.
SK
Citalopram Teva 20 mg filmdragerade tabletter
NL/H/0692/002 23001 TEVA SWEDEN AB SE
Citalopram - Teva 20 mg NL/H/0692/002 30/0180/06-S TEVA PHARMACEUTICALS CR, S.R.O.
SK
Citalopram-Teva 10 mg potahované tablety
NL/H/0692/001 30/121/06-C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
Citalopram-Teva 10 mg apvalkotās tabletes
NL/H/0692/001 06-0095 TEVA PHARMA B.V. LV
Citalopram Teva 20mg Film-coated Tablets
NL/H/0692/002 PA 749/19/2 TEVA PHARMA B.V. IE
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/015 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg potahované tablety
NL/H/0692/002 30/122/06-C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/019 TEVA PHARMA B.V. LT
Citalopram 10mg film-coated tablets
NL/H/0692/001 PL 00289/0927 TEVA UK LIMITED UK
Citalopram 40 PCH, filmomhulde tabletten 40 mg
NL/H/0692/003 RVG 31127 PHARMACHEMIE B.V NL
Citalopram 20 PCH, filmomhulde tabletten 20 mg
NL/H/0692/002 RVG 31126 PHARMACHEMIE B.V NL
Citalopram-Teva 10 mg, õhukese polümeerikattega tabletid
NL/H/0692/001 513006 TEVA PHARMA B.V. EE
List of nationally authorised medicinal products EMA/583896/2017 Page 51/93
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
Citalopram-Teva 20 mg apvalkotās tabletes
NL/H/0692/002 06-0096 TEVA PHARMA B.V. LV
Citalopram Teva 10 mg filmdragerade tabletter
NL/H/0692/001 23000 TEVA SWEDEN AB SE
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/023 TEVA PHARMA B.V. LT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/022 TEVA PHARMA B.V. LT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/030 TEVA PHARMA B.V. LT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/025 TEVA PHARMA B.V. LT
Citalopram Teva 10mg Film-coated Tablets
NL/H/0692/001 PA 749/19/1 TEVA PHARMA B.V. IE
Citalopram-Teva 20 mg, õhukese polümeerikattega tabletid
NL/H/0692/002 512806 TEVA PHARMA B.V. EE
Citalopram 10 PCH, filmomhulde tabletten 10 mg
NL/H/0692/001 RVG 31125 PHARMACHEMIE B.V NL
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/029 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/018 TEVA PHARMA B.V. LT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/020 TEVA PHARMA B.V. LT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/003 LT/1/06/0576/024 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/012 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/017 TEVA B.V LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/013 TEVA PHARMA B.V. LT
List of nationally authorised medicinal products EMA/583896/2017 Page 52/93
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
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/011 TEVA PHARMA B.V. LT
Citalopram-Teva 40 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/027 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/014 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/010 TEVA PHARMA B.V. LT
Citalopram-Teva 20 mg plėvele dengtos tabletės
NL/H/0692/002 LT/1/06/0576/016 TEVA PHARMA B.V. LT
PRAM 20 mg Potahované tablety
not available 30/109/04-C G.L. PHARMA GMBH CZ
PRAM 20 mg Potahované tablety
not available 30/109/04-C G.L. PHARMA GMBH CZ
RICAP 40 mg/ml gocce orali, soluzione
not available 036056012 I.B.N. SAVIO S.R.L. IT
RICAP 20 mg compresse rivestite con film
not available 036056024 I.B.N. SAVIO S.R.L. IT
RICAP 40 mg compresse rivestite con film
not available 036056036 I.B.N. SAVIO S.R.L. IT
Oropram 20 mg, tabletki powlekane
DK/H/0762/002 12040 +PHARMA ARZNEIMITTEL GMBH
PL
Citalopram +pharma 20 mg potahované tablety
DK/H/0762/002 30/379/05-C +PHARMA ARZNEIMITTEL GMBH
CZ
CITALOPRAM ACTAVIS 20 mg apvalkotās tabletes
DK/H/0762/002 05-0462 ACTAVIS NORDIC A/S LV
Citalopram Actavis 10 mg film-coated tablets
DK/H/0762/001 21105 ACTAVIS NORDIC A/S FI
Citalopram ”Actavis”, filmovertrukne tabletter
DK/H/0762/001 32806 ACTAVIS NORDIC A/S DK
Citalopram Actavis 10 mg plévele dengtos tabletés
DK/H/0762/001 LT/1/05/0397/001-015 ACTAVIS NORDIC A/S LT
List of nationally authorised medicinal products EMA/583896/2017 Page 53/93
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
CITALOPRAM ACTAVIS 20 MG TABLETTI, KALVOPÄÄLLYSTEINEN
DK/H/0762/002 21106 ACTAVIS NORDIC A/S FI
Citalopram ”Actavis”, filmovertrukne tabletter
DK/H/0762/002 32807 ACTAVIS NORDIC A/S DK
Citalopram Actavis, 20 mg õhukese polümeerikattega tabletid
DK/H/0762/002 491305 ACTAVIS NORDIC A/S EE
Citalopram Actavis 20 mg plévele dengtos tabletés
DK/H/0762/002 LT/1/05/0397/016-030 ACTAVIS NORDIC A/S LT
Citalopram Actavis 40 mg film-coated tablets
DK/H/0762/003 21107 ACTAVIS NORDIC A/S FI
Citalopram ”Actavis”, filmovertrukne tabletter
DK/H/0762/003 32808 ACTAVIS NORDIC A/S DK
Citalopram Actavis, 40 mg õhukese polümeerikattega tabletid
DK/H/0762/003 491605 ACTAVIS NORDIC A/S EE
Citalopram Actavis 40 mg plévele dengtos tabletés
DK/H/0762/003 LT/1/05/0397/031-040 ACTAVIS NORDIC A/S LT
Citalopram Actavis 40 mg plévele dengtos tabletés
DK/H/0762/003 LT/1/05/0397/041-045 ACTAVIS NORDIC A/S LT
Citalopram 20 mg Film-coated tablets
UK/H/0531/002 PL 04569/0480 GENERICS [UK] LIMITED UK
Ciprager 20 mg Film-coated tablets
UK/H/0531/002 PA0577/047/002 MCDERMOTT LABORATORIES LTD
IE
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046441 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 54/93
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
Citalopram Mylan 20 mg Filmtabletten
UK/H/0531 BE242566 MYLAN DURA GMBH BE
Citalopram Mylan 20 mg filmomhulde tabletten
UK/H/0531/002 BE242566 MYLAN DURA GMBH BE
Citalopram Mylan 20 mg filmomhulde tabletten
UK/H/0531/002 BE242557 MYLAN DURA GMBH BE
Citalopram dura 20 mg Filmtabletten
UK/H/0531/002 55313.01.00 MYLAN DURA GMBH DE
Citalopram Mylan Generics 20 mg compresse rivestite con film
UK/H/0531/002 36046249 MYLAN S.P.A. IT
Citalopram Mylan Generics 20 mg compresse rivestite con film
UK/H/0531/002 36046237 MYLAN S.P.A. IT
Citalopram Mylan Generics 20 mg compresse rivestite con film
UK/H/0531/002 36046225 MYLAN S.P.A. IT
Citalopram Mylan Generics 20 mg compresse rivestite con film
UK/H/0531/002 36046213 MYLAN S.P.A. IT
Citalopram Mylan Generics 20 mg compresse rivestite con film
UK/H/0531/002 36046201 MYLAN S.P.A. IT
Citalopram Arcana 10 mg – Filmtabletten
UK/H/0531/001 1-24781 ARCANA ARZNEIMITTEL GMBH
AT
Citalopram dura 10 mg Filmtabletten
UK/H/0531/001 55313.00.00 MYLAN DURA GMBH DE
Ciprager 10 mg Film-coated tablets
UK/H/0531/001 PA0577/047/001 MCDERMOTT LABORATORIES LTD
IE
List of nationally authorised medicinal products EMA/583896/2017 Page 55/93
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
Citalopram 10 mg Film-coated tablets
UK/H/0531/001 PL 04569/0479 GENERICS [UK] LIMITED UK
Citalopram Arcana 20 mg – Filmtabletten
UK/H/0531/002 1-24782 ARCANA ARZNEIMITTEL GMBH
AT
Citalopram Mylan 20 mg comprimés pelliculés
UK/H/0531/002 2003020049 MYLAN BVBA/SPRL LU
Citalopram Mylan 10 mg filmdragerade tabletter
SE/H/0303/001 17748 MYLAN AB SE
Citalopram ”Mylan”, filmovertrukne tabletter
SE/H/0303/001 34311 MYLAN AB DK
Citalopram Mylan 20 mg filmdragerade tabletter
SE/H/0303/002 17749 MYLAN AB SE
Citalopram ”Mylan”, filmovertrukne tabletter
SE/H/0303/002 34312 MYLAN AB DK
Citalopram Mylan 30 mg filmdragerade tabletter
SE/H/0303/003 18825 MYLAN AB SE
Citalopram ”Mylan”, filmovertrukne tabletter
SE/H/0303/003 35533 MYLAN AB DK
Citalopram Mylan 40 mg filmdragerade tabletter
SE/H/0303/004 18826 MYLAN AB SE
Citalopram ”Mylan”, filmovertrukne tabletter
SE/H/0303/004 35534 MYLAN AB DK
Citalopram Arcana 40 mg – Filmtabletten
UK/H/0531/003 1-24783 ARCANA ARZNEIMITTEL GMBH
AT
Citalopram dura 40 mg Filmtabletten
UK/H/0531/003 55313.02.00 MYLAN DURA GMBH DE
Ciprager 40 mg Film-coated tablets
UK/H/0531/003 PA0577/047/03 MCDERMOTT LABORATORIES LTD
IE
Citalopram 40 mg Film-coated tablets
UK/H/0531/003 PL 04569/0481 GENERICS [UK] LIMITED UK
Citagen 10 mg filmtabletta
not available OGYI-T-9357/01 GENERICS [UK] LIMITED HU
Citagen 10 mg filmtabletta
not available OGYI-T-9357/02 GENERICS [UK] LIMITED HU
List of nationally authorised medicinal products EMA/583896/2017 Page 56/93
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
Citagen 10 mg filmtabletta
not available OGYI-T-9357/03 GENERICS [UK] LIMITED HU
Citagen 10 mg filmtabletta
not available OGYI-T-9357/04 GENERICS [UK] LIMITED HU
Citagen 20 mg filmtabletta
not available OGYI-T-9357/05 GENERICS [UK] LIMITED HU
Citagen 20 mg filmtabletta
not available OGYI-T-9357/06 GENERICS [UK] LIMITED HU
Citagen 20 mg filmtabletta
not available OGYI-T-9357/07 GENERICS [UK] LIMITED HU
Citagen 20 mg filmtabletta
not available OGYI-T-9357/08 GENERICS [UK] LIMITED HU
Citalopram Mylan Generics Italia 40 mg/ml gocce orali, soluzione
not available 036657017 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046288 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046290 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046302 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046314 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046326 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 57/93
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
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046338 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046340 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046353 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046365 MYLAN S.P.A. IT
Citalopram Mylan 40 mg Filmtabletten
UK/H/0531/003 BE265833 MYLAN BVBA/SPRL BE
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046011 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046023 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046035 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046047 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 58/93
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
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046050 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046062 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046074 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046086 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046098 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046100 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046112 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046124 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 59/93
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
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046187 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046199 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046136 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046148 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046151 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046163 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 20 mg compresse rivestite con film
UK/H/0531/002 036046175 MYLAN S.P.A. IT
Citalopram Mylan Generics 20 mg compresse rivestite con film
UK/H/0531/002 036046264 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 60/93
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
Citalopram Mylan Generics 20 mg compresse rivestite con film
UK/H/0531/002 036046276 MYLAN S.P.A. IT
Citalopram Mylan 20 mg comprimés pelliculés
UK/H/0531/002 BE242541 MYLAN BVBA/SPRL BE
Citalopram Mylan 20 mg comprimés pelliculés
UK/H/0531/002 BE242557 MYLAN BVBA/SPRL BE
Citalopram Mylan 20 mg comprimés pelliculés
UK/H/0531/002 BE242566 MYLAN BVBA/SPRL BE
Citalopram MYLAN 20 mg comprimidos recubiertos con película EFG
not available 66095 MYLAN PHARMACEUTICALS S.L.
ES
Citalopram MYLAN 30 mg comprimidos recubiertos con película EFG
not available 67521 MYLAN PHARMACEUTICALS S.L.
ES
Citalox 20 mg filmsko obložene tablete
not available 5363-I-620/10 GENERICS [UK] LIMITED SI
Citalopram dura 30 mg Filmtabletten
not available 67589.00.00 MYLAN DURA GMBH DE
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046377 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046389 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046391 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 61/93
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
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046403 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046415 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046427 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046439 MYLAN S.P.A. IT
CITALOPRAM MYLAN GENERICS 40 mg compresse rivestite con film
UK/H/0531/003 036046454 MYLAN S.P.A. IT
Citalopram Mylan 40 mg Filmtabletten
UK/H/0531/003 BE265815 MYLAN BVBA/SPRL BE
Citalopram Mylan 40 mg Filmtabletten
UK/H/0531/003 BE265824 MYLAN BVBA/SPRL BE
Citalopram Mylan 20 mg, filmomhulde tabletten
not available RVG 28672 MYLAN B.V. NL
Citalopram Mylan 40 mg, filmomhulde tabletten
not available RVG 28673 MYLAN B.V. NL
Cilodral 10 mg Δισκία επικαλυμμένα με υμένιο
not available 20434 REMEDICA LTD CY
Cilodral 20 mg Δισκία επικαλυμμένα με υμένιο
not available 20435 REMEDICA LTD CY
Cilodral 40 mg Δισκία επικαλυμμένα με υμένιο
not available 20436 REMEDICA LTD CY
List of nationally authorised medicinal products EMA/583896/2017 Page 62/93
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
ADEPRENAL not available 24597/14/18-09-2015 ADELCO CHROMATOURGIA ATHINON E COLOCOTRONIS BROS SA
GR
Citalopram Alter 30 mg comprimidos recubiertos con película
not available 66.018 LABORATORIOS ALTER, S.A. ES
Citalopram Alter 20 mg comprimidos recubiertos con película
not available 66.017 LABORATORIOS ALTER, S.A. ES
Citalopram ”STADA” 30mg, filmovertrukne tabletter
not available 38263 STADA ARZNEIMITTEL AG DK
Citalopram 20 mg film-coated tablets
not available PL 11311/0416 TILLOMED LABORATORIES LTD
UK
Citalopram 40mg film-coated tablets
not available PL 11311/0418 TILLOMED LABORATORIES LTD
UK
Citalopram 10mg film-coated Tablets
not available PL 11311/0415 TILLOMED LABORATORIES LTD
UK
citalopram cinfa 30 mg comprimidos recubiertos con película EFG
not available 67.805 LABORATORIOS CINFA, S.A. ES
CITALOPRAM ARROW 20 mg, comprimé pelliculé sécable
not available 27291 ARROW GENERIQUES FR
CITALOPRAM ratiopharm Italia 40 mg/ml gocce orali, soluzione
not available 036038014 RATIOPHARM ITALIA S.R.L. IT
Citalopram ratiopharm 20 mg compresse rivestite con film
not available 035892013 RATIOPHARM GMBH IT
Citalopram-Teva 20 mg filmtabletta
not available OGYI-T-9474/01 TEVA MAGYARORSZÁG ZRT HU
Citalopram ratiopharm 40 mg compresse rivestite con film
not available 035892052 RATIOPHARM GMBH IT
List of nationally authorised medicinal products EMA/583896/2017 Page 63/93
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
Citalopram ratiopharm 40 mg compresse rivestite con film
not available 035892064 RATIOPHARM GMBH IT
Citalopram ratiopharm 20 mg compresse rivestite con film
not available 035892049 RATIOPHARM GMBH IT
Citalopram ratiopharm 20 mg compresse rivestite con film
not available 035892037 RATIOPHARM GMBH IT
Citalopram ratiopharm 20 mg compresse rivestite con film
not available 035892025 RATIOPHARM GMBH IT
CITESINT 20 mg compresse rivestite con film
not available 036484018 GENETIC SPA IT
CITESINT 40 mg compresse rivestite con film
not available 036484020 GENETIC SPA IT
CITESINT 40 mg/ml gocce orali, soluzione
not available 036484032 GENETIC SPA IT
CINAVOL 20 mg compresse rivestite con film
not available 036483016 GENETIC SPA IT
CINAVOL 40 mg compresse rivestite con film
not available 036483028 GENETIC SPA IT
CINAVOL 40 mg/ml gocce orali, soluzione
not available 036483030 GENETIC SPA IT
CINAVOL 40 mg/ml concentrato per soluzione per infusione
not available 036483042 GENETIC SPA IT
CITALOPRAM ALMUS 20 mg, comprimé pelliculé sécable
not available 3400936477131 BIOGARAN FR
List of nationally authorised medicinal products EMA/583896/2017 Page 64/93
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
CITALOPRAM AUROBINDO 20 mg compresse rivestite con film
not available 036675015 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Citalopram Hennig® 40 mg Filmtabletten
not available 54076.02.00 HENNIG ARZNEIMITTEL GMBH & CO. KG
DE
Pram 10 mg, õhukese polümeerikattega tabletid
not available 421803 G.L. PHARMA GMBH EE
Pram 20 mg, õhukese polümeerikattega tabletid
not available 422003 G.L. PHARMA GMBH EE
Pram 40 mg, õhukese polümeerikattega tabletid
not available 421903 G.L. PHARMA GMBH EE
Citalopram Jubilant 10 mg filmdragerade tabletter
NL/H/2919/001 49278 JUBILANT PHARMACEUTICALS NV
SE
Citalopram Jubilant 20 mg filmdragerade tabletter
NL/H/2919/002 49279 JUBILANT PHARMACEUTICALS NV
SE
Citalopram Jubilant 30 mg filmdragerade tabletter
NL/H/2919/003 49280 JUBILANT PHARMACEUTICALS NV
SE
Citalopram Jubilant 40 mg filmdragerade tabletter
NL/H/2919/004 49281 JUBILANT PHARMACEUTICALS NV
SE
Citalopram ”Jubilant”, filmovertrukne tabletter
NL/H/2919/001 52337 JUBILANT PHARMACEUTICALS NV
DK
Citalopram ”Jubilant”, filmovertrukne tabletter
NL/H/2919/002 52338 JUBILANT PHARMACEUTICALS NV
DK
Citalopram ”Jubilant”, filmovertrukne tabletter
NL/H/2919/003 52339 JUBILANT PHARMACEUTICALS NV
DK
Citalopram ”Jubilant”, filmovertrukne tabletter
NL/H/2919/004 52340 JUBILANT PHARMACEUTICALS NV
DK
List of nationally authorised medicinal products EMA/583896/2017 Page 65/93
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
CITALVIR 10 mg comprimidos recubiertos con película
not available 66.402 ABABOR PHARMACEUTICALS, S.L.
ES
CITALVIR 20 mg comprimidos recubiertos con película EFG
not available 66.401 ABABOR PHARMACEUTICALS, S.L.
ES
DALSAN 10 mg filmtabletta
HU/H/0109/001/MR OGYI-T-9985/01 EGIS PHARMACEUTICALS PLC
HU
Dalsan 10 mg apvalkotās tabletes
HU/H/0109/001-003/DC
06-0054 EGIS PHARMACEUTICALS PLC
LV
DALSAN 20 mg filmtabletta
HU/H/0109/002/MR OGYI-T-9985/02 EGIS PHARMACEUTICALS PLC
HU
Dalsan 20 mg apvalkotās tabletes
HU/H/0109/001-003/MR
06-0055 EGIS PHARMACEUTICALS PLC
LV
DALSAN 40 mg filmtabletta
HU/H/0109/003/MR OGYI-T-9985/03 EGIS PHARMACEUTICALS PLC
HU
Dalsan 40 mg apvalkotās tabletes
HU/H/0109/001-003/MR
06-0056 EGIS PHARMACEUTICALS PLC
LV
CITALOPRAM 10MG FILM-COATED TABLETS
not available PL 30306/0618 ACTAVIS GROUP PTC EHF. UK
CITALOPRAM 20MG FILM-COATED TABLETS
not available PL 30306/0619 ACTAVIS GROUP PTC EHF. UK
CITALOPRAM 40MG FILM-COATED TABLETS
not available PL 30306/0620 ACTAVIS GROUP PTC EHF. UK
Citalopram 40 mg/ml oral drops, solution
not available PL 28176/0164 STRIDES ARCOLAB INTERNATIONAL LIMITED
UK
Citalopram ratiopharm 20 mg comprimidos recubiertos con película EFG
not available 64.738 RATIOPHARM ESPAÑA, S.A ES
citalopram-biomo® 10 mg Filmtabletten
not available 50941.00.00 BIOMO PHARMA GMBH DE
citalopram-biomo® 20 mg Filmtabletten
not available 50941.01.00 BIOMO PHARMA GMBH DE
List of nationally authorised medicinal products EMA/583896/2017 Page 66/93
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
citalopram-biomo® 40 mg Filmtabletten
not available 50941.02.00 BIOMO PHARMA GMBH DE
citalopram-biomo® 30 mg Filmtabletten
not available 62359.00.00 BIOMO PHARMA GMBH DE
Xadorek 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
not available 65424/15-7-2014 MINERVA PHARMACEUTICAL S.A
GR
Xadorek 40 mg επικαλυμμένα με λεπτό υμένιο δισκία
not available 64572/15-7-2014 MINERVA PHARMACEUTICAL S.A
GR
Citalopram Wynn 10 mg comprimidos revestidos por película
not available 5427265 AXONE, LDA. PT
Citalopram Wynn 10 mg comprimidos revestidos por película
not available 5427257 AXONE, LDA. PT
CITALOPRAM ALMUS 20 mg comprimidos recubiertos con película EFG
ES/H/0146/002 70369 ALMUS FARMACEUTICA S.A ES
CITALOPRAM ALMUS 30 mg comprimidos recubiertos con película EFG
ES/H/0146/003 70370 ALMUS FARMACEUTICA S.A ES
CITALOPRAM STADA 20 mg comprimidos recubiertos con película EFG
not available 66.035 LABORATORIO STADA, S.L. ES
Citalopram 10mg Film-coated Tablets
not available PL 17907/0089 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
Citalopram 20mg Film-coated Tablets
not available PL 17907/0090 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
Citalopram 40mg Film-coated Tablets
not available PL 17907/0091 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
List of nationally authorised medicinal products EMA/583896/2017 Page 67/93
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
Citalopram EDIGEN 10 mg comprimidos recubiertos con película
not available 66.278 ARISTO PHARMA IBERIA, S.L.
ES
Citalopram EDIGEN 20 mg comprimidos recubiertos con película EFG
not available 66.277 ARISTO PHARMA IBERIA, S.L.
ES
Citalopram EDIGEN 40 mg comprimidos recubiertos con película EFG
not available 66.280 ARISTO PHARMA IBERIA, S.L.
ES
CITALOPRAM TecniGen 40 mg/ml gocce orali, soluzione
not available 036057014 TECNIGEN S.R.L. IT
CITALOPRAM MYLAN 20 mg, comprimé pelliculé sécable
not available NL 27 236 MYLAN S.A.S FR
Citalopram Q-Pharm 10 mg Filmtabletten
not available 90967.00.00 JUTA PHARMA GMBH DE
Citalopram Q-Pharm 20 mg Filmtabletten
not available 90968.00.00 JUTA PHARMA GMBH DE
Citalopram Q-Pharm 40 mg Filmtabletten
not available 90969.00.00 JUTA PHARMA GMBH DE
FRIMAIND 20 mg compresse rivestite con film
not available 036143016 SO.SE.PHARM S.R.L. IT
FRIMAIND 40 mg compresse rivestite con film
not available 036143028 SO.SE.PHARM S.R.L. IT
FRIMAIND 40 mg/ml gocce orali, soluzione
not available 036143055 SO.SE.PHARM S.R.L. IT
Citalostad 40 mg Filmtabletten
not available 1-25316 STADA ARZNEIMITTEL GMBH
AT
List of nationally authorised medicinal products EMA/583896/2017 Page 68/93
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
Citalopram Teva-Rimafar 30 mg comprimidos recubiertos con pelicula EFG
not available 67579 TEVA PHARMA S.L.U ES
Citabax 10, 10 mg, tabletki powlekane
not available 10915 RANBAXY POLAND SP. ZO.O PL
Citabax 20, 20 mg, tabletki powlekane
not available 10916 RANBAXY POLAND SP. ZO.O PL
Citabax 40, 40 mg, tabletki powlekane
not available 10917 RANBAXY POLAND SP. ZO.O PL
CITALOPRAM DOC 40 mg/ml gocce orali, soluzione
not available 036653018 DOC GENERICI S.R.L. IT
Citalopram Genericon 10 mg Filmtabletten
NL/H/0312/001 1-24570 GENERICON PHARMA GESELLSCHAFT M.B.H.
AT
Citalopram Genericon 20 mg Filmtabletten
NL/H/0312/002 1-24571 GENERICON PHARMA GESELLSCHAFT M.B.H.
AT
CITALOPRAM ACTAVIS 10 MG, FILMOMHULDE TABLETTEN
NL/H/0312/001 RVG 25419 ACTAVIS GROUP PTC EHF. NL
CITALOPRAM ACTAVIS 20 MG, FILMOMHULDE TABLETTEN
NL/H/0312/002 RVG 25420 ACTAVIS GROUP PTC EHF. NL
CITALOPRAM ACTAVIS 40 MG, FILMOMHULDE TABLETTEN
NL/H/0312/003 RVG 25421 ACTAVIS GROUP PTC EHF. NL
Citalopram 10mg Film-Coated Tablets
NL/H/0312/001-003/MR
0142/0543 ACTAVIS UK LTD. UK
Citalopram 20mg Film-Coated Tablets
NL/H/0312/001-003/MR
0142/0544 ACTAVIS UK LTD. UK
Citalopram 40mg Film-Coated Tablets
NL/H/0312/001-003/MR
0142/0545 ACTAVIS UK LTD. UK
Exenadil® 20 mg Eπικαλυμμένα με λεπτό υμένιο δισκία
not available 43899/12 TARGET PHARMA SINGLE MEMBER PRIVATE LTD
GR
List of nationally authorised medicinal products EMA/583896/2017 Page 69/93
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
Exenadil® 40 mg Eπικαλυμμένα με λεπτό υμένιο δισκία
not available 43900/12 TARGET PHARMA SINGLE MEMBER PRIVATE LTD
GR
Exenadil® 40 mg/ml Πόσιμες σταγόνες, διάλυμα
not available 65428/15 TARGET PHARMA SINGLE MEMBER PRIVATE LTD
GR
Citalopram 10 mg Tablets
not available PL 36390/0024 CIPLA (EU) LIMITED UK
Citalopram 20 mg Tablets
not available PL 36390/0025 CIPLA (EU) LIMITED UK
Citalopram 40 mg Tablets
not available PL 36390/0026 CIPLA (EU) LIMITED UK
PREFUCET not available 13959 RAFARM SA. GR PREFUCET not available 13960 RAFARM SA. GR PREFUCET not available 7784 RAFARM SA. GR Citalopram PENSA 20 mg compresse rivestite con film
not available 036392013 PENSA PHARMA S.P.A. IT
Citalopram Pensa 20 mg compresse rivestite con film
not available 036392025 PENSA PHARMA S.P.A. IT
Citalopram Pensa Pharma 40 mg/ml gocce orali, soluzione
not available 038199016 PENSA PHARMA S.P.A. IT
Citalopram PENSA 40 mg compresse rivestite con film
not available 036392037 PENSA PHARMA S.P.A. IT
Citalopram AL 30 mg Filmtabletten
not available 67591.00.00 ALIUD PHARMA GMBH DE
CITALOPRAM ZENTIVA 40 MG/ML GOCCE ORALI, SOLUZIONE
not available 036254011 ZENTIVA ITALIA SRL IT
CITALEC 10 Zentiva potahované tablety
CZ/H/0127/001 30/552/05-C ZENTIVA, A.S. CZ
List of nationally authorised medicinal products EMA/583896/2017 Page 70/93
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
CITALEC 20 Zentiva potahované tablety
CZ/H/0127/002 30/553/05-C ZENTIVA, A.S. CZ
CITALEC 10 Zentiva filmom obalené tablety
CZ/H/0127/001 30/0357/06-S ZENTIVA, A.S. SK
CITALEC 10 Zentiva filmom obalené tablety
CZ/H/0127/001 30/0357/06-S ZENTIVA, A.S. SK
CITALEC 10 Zentiva filmom obalené tablety
CZ/H/0127/001 30/0357/06-S ZENTIVA, A.S. SK
CITALEC 20 Zentiva filmom obalené tablety
CZ/H/0127/002 30/0358/06-S ZENTIVA, A.S. SK
CITALEC 10 Zentiva filmom obalené tablety
CZ/H/0127/001 30/0357/06-S ZENTIVA, A.S. SK
CITALEC 10 Zentiva filmom obalené tablety
CZ/H/0127/001 30/0357/06-S ZENTIVA, A.S. SK
CITALEC 20 Zentiva filmom obalené tablety
CZ/H/0127/002 30/0358/06-S ZENTIVA, A.S. SK
CITALEC 20 Zentiva filmom obalené tablety
CZ/H/0127/002 30/0358/06-S ZENTIVA, A.S. SK
CITALEC 20 Zentiva filmom obalené tablety
CZ/H/0127/002 30/0358/06-S ZENTIVA, A.S. SK
CITALEC 20 Zentiva filmom obalené tablety
CZ/H/0127/002 30/0358/06-S ZENTIVA, A.S. SK
CITALEC 20, 20 mg õhukese polümeerikattega tabletid
CZ/H/0127/002 403202 ZENTIVA, A.S. EE
CITALEC 20 Zentiva potahované tablety
CZ/H/0127/002 30/553/05-C ZENTIVA, A.S. CZ
CITALEC 20 Zentiva potahované tablety
CZ/H/0127/002 30/553/05-C ZENTIVA, A.S. CZ
CITALEC 20 Zentiva potahované tablety
CZ/H/0127/002 30/553/05-C ZENTIVA, A.S. CZ
CITALEC 20 Zentiva potahované tablety
CZ/H/0127/002 30/553/05-C ZENTIVA, A.S. CZ
List of nationally authorised medicinal products EMA/583896/2017 Page 71/93
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
CITALEC 10 Zentiva potahované tablety
CZ/H/0127/001 30/552/05-C ZENTIVA, A.S. CZ
CITALEC 10 Zentiva potahované tablety
CZ/H/0127/001 30/552/05-C ZENTIVA, A.S. CZ
CITALEC 10 Zentiva potahované tablety
CZ/H/0127/001 30/552/05-C ZENTIVA, A.S. CZ
CITALEC 10 Zentiva potahované tablety
CZ/H/0127/001 30/552/05-C ZENTIVA, A.S. CZ
CITALEC 20, 20 mg õhukese polümeerikattega tabletid
CZ/H/0127/002 403202 ZENTIVA, A.S. EE
CITALEC 20, 20 mg õhukese polümeerikattega tabletid
CZ/H/0127/002 403202 ZENTIVA, A.S. EE
CITALEC 20, 20 mg õhukese polümeerikattega tabletid
CZ/H/0127/002 403202 ZENTIVA, A.S. EE
CITALEC 20, 20 mg õhukese polümeerikattega tabletid
CZ/H/0127/002 403202 ZENTIVA, A.S. EE
CITALOPRAM ZENTIVA 20 mg, comprimé pelliculé sécable
not available 367 432-5 SANOFI-AVENTIS FRANCE FR
CITALOPRAM ZENTIVA 20 mg, comprimé pelliculé sécable
not available 565 603-0 SANOFI-AVENTIS FRANCE FR
Citalopram 40mg Tablets not available PL 17780/0038 WINTHROP PHARMACEUTICALS UK LTD
UK
Citalopram 20mg Tablets not available PL 17780/0037 WINTHROP PHARMACEUTICALS UK LTD
UK
List of nationally authorised medicinal products EMA/583896/2017 Page 72/93
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
Citalopram 10mg Tablets not available PL 17780/0036 WINTHROP PHARMACEUTICALS UK LTD
UK
CitaLich® 10 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/001 58944.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 10 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/001 58944.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 10 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/001 58944.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 40 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/003 58944.02.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 40 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/003 58944.02.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 40 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/003 58944.02.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 40 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/003 58944.02.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 10 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/001 58944.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 20 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/002 58944.01.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 20 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/002 58944.01.00 WINTHROP ARZNEIMITTEL GMBH
DE
CitaLich® 20 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/002 58944.01.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/583896/2017 Page 73/93
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
CitaLich® 20 mg Filmtabletten Wirkstoff: Citalopram
DE/H/1319/002 58944.01.00 WINTHROP ARZNEIMITTEL GMBH
DE
CITALEC 10 Zentiva potahované tablety
CZ/H/0127/001 30/552/05-C ZENTIVA, A.S. CZ
CITALEC 10 Zentiva filmom obalené tablety
CZ/H/0127/001 30/0357/06-S ZENTIVA, A.S. SK
CITALEC 20, 20 mg õhukese polümeerikattega tabletid
CZ/H/0127/002 403202 ZENTIVA, A.S. EE
CITALEC 20 Zentiva potahované tablety
CZ/H/0127/002 30/553/05-C ZENTIVA, A.S. CZ
CITALEC 20 Zentiva filmom obalené tablety
CZ/H/0127/002 30/0358/06-S ZENTIVA, A.S. SK
Citalopram-Zentiva 20 mg filmtabletta
DE/H/1319/002 OGYI-T-10046/01 ZENTIVA HU KFT HU
Citalopram-Zentiva 40 mg filmtabletta
DE/H/1319/003 OGYI-T-10046/02 ZENTIVA HU KFT HU
CITALOPRAM ZENTIVA ITALIA 20 mg compresse rivestite con film
not available 036656015 ZENTIVA ITALIA SRL IT
Citalopram Zentiva 30 mg comprimidos recubiertos con película EFG
not available 67545 ZENTIVA, K.S. ES
Citalopram Zentiva 20 mg comprimidos recubiertos con película EFG
not available 67544 ZENTIVA, K.S. ES
Citalopram Zentiva 20 mg comprimidos recubiertos con película EFG
not available 67544 ZENTIVA, K.S. ES
List of nationally authorised medicinal products EMA/583896/2017 Page 74/93
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
Pram 10 mg plėvele dengtos tabletės
not available LT/1/03/2944/001 G.L. PHARMA GMBH LT
Pram 20 mg plevele dengtos tabletes
not available LT/1/03/2944/002 G.L. PHARMA GMBH LT
Pram 40 mg plėvele dengtos tabletės
not available LT/1/03/2944/003 G.L. PHARMA GMBH LT
TALOSIN 20 mg, Επικαλυμμένα με λεπτό υμένιο δισκία
not available 21091/13/05-06-2014 BENNETT PHARMACEUTICALS SA
GR
TALOSIN 40 mg, Επικαλυμμένα με λεπτό υμένιο δισκία
not available 21092/13/05-06-2014 BENNETT PHARMACEUTICALS SA
GR
CITALOPRAM CRISTERS 20 mg, comprimé pelliculé sécable
not available 34009 366 508 8 6 CRISTERS FR
CITALOPRAM CRISTERS 20 mg, comprimé pelliculé sécable
not available 34009 366 509 4 7 CRISTERS FR
CITALOPRAM CRISTERS 20 mg, comprimé pelliculé sécable
not available 34009 565 999 1 2 CRISTERS FR
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 5619960 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 5619978 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 5620000 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 5620018 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 75/93
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
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 10 mg comprimidos revestidos por película
not available 10/H/0124/001 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 20 mg comprimidos revestidos por película
not available 10/H/0124/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
List of nationally authorised medicinal products EMA/583896/2017 Page 76/93
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
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Citalopram Aurobindo 40 mg comprimidos revestidos por película
not available 10/H/0124/003 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
CITALOPRAM ZYDUS 20 mg, comprimé pelliculé sécable
not available 34009 388 171 6 4 ZYDUS FRANCE FR
LOPRACIL®, πόσιμες σταγόνες, διάλυμα, 40mg/ml
not available 43228/11/4-5-2012 MEDICUS A.E GR
LOPRACIL®, επικαλυμμένa με λεπτό υμένιο δισκία, 40mg/tab
not available 43225/11/4-5-2012 MEDICUS A.E GR
LOPRACIL®, επικαλυμμένa με λεπτό υμένιο δισκία, 20mg/tab
not available 43224/11/4-5-2012 MEDICUS A.E GR
CITALOPRAM STADA 30 mg comprimidos recubiertos con película EFG
not available 66.034 LABORATORIO STADA, S.L. ES
Citalopram 10mg Film-Coated Tablets
not available PL 20416/0301 CRESCENT PHARMA LIMITED UK
Citalopram 20mg Film-Coated Tablets
not available PL 20416/0302 CRESCENT PHARMA LIMITED UK
Citalopram 40mg Film-Coated Tablets
not available PL 20416/0303 CRESCENT PHARMA LIMITED UK
List of nationally authorised medicinal products EMA/583896/2017 Page 77/93
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
CITALOPRAM TecniGen 20 mg compresse rivestite con film
not available 036057040 TECNIGEN S.R.L. IT
CITALOPRAM TecniGen 40 mg compresse rivestite con film
not available 036057053 TECNIGEN S.R.L. IT
CITALOPRAM ISOMED 20 mg, comprimé pelliculé sécable
not available NL27608 TEVA SANTÉ FR
Citalopram Vitabalans 20 mg kalvopäällysteiset tabletit
SE/H/0818/001 28206 VITABALANS OY FI
Citalopram Vitabalans 40 mg kalvopäällysteiset tabletit
SE/H/0818/002 28207 VITABALANS OY FI
Citalopram ”Vitabalans”, filmovertrukne tabletter
SE/H/0818/001 46084 VITABALANS OY DK
Citalopram ”Vitabalans”, filmovertrukne tabletter
SE/H/0818/002 46085 VITABALANS OY DK
Citalopram Vitabalans 20 mg fildragerade tabletter
SE/H/0818/001 43373 VITABALANS OY SE
Citalopram Vitabalans 40 mg fildragerade tabletter
SE/H/0818/002 43374 VITABALANS OY SE
Citalopram Vitabalans 20 mg filmdrasjerte tabletter
SE/H/818/001-002/DC 09-7212 VITABALANS OY NO
Citalopram Vitabalans 40 mg filmdrasjerte tabletter
SE/H/818/001-002/DC 09-7213 VITABALANS OY NO
Citalopram Vitabalans, 20 mg õhukese polümeerikattega tabletid
SE/H/0818/001 732311 VITABALANS OY EE
List of nationally authorised medicinal products EMA/583896/2017 Page 78/93
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
Citalopram Vitabalans, 40 mg õhukese polümeerikattega tabletid
SE/H/0818/002 732411 VITABALANS OY EE
Citalopram Vitabalans 20 mg apvalkotas tabletes
SE/H/0818/001 11-0174 VITABALANS OY LV
Citalopram Vitabalans 40 mg apvalkotās tabletes
SE/H/0818/002 11-0175 VITABALANS OY LV
Citalopram Vitabalans 20 mg Filmtabletten
SE/H/0818/001 80483.00.00 VITABALANS OY DE
Citalopram Vitabalans 40 mg Filmtabletten
SE/H/0818/002 80484.00.00 VITABALANS OY DE
Citalopram Vitabalans 20 mg filmom obalené tablety
SE/H/0818/001 30/0306/11-S VITABALANS OY SK
Citalopram Vitabalans 40 mg filmom obalené tablety
SE/H/0818/002 30/0307/11-S VITABALANS OY SK
Citalopram Vitabalans 20 mg potahované tablety
SE/H/0818/001 30/111/11-C VITABALANS OY CZ
Citalopram Vitabalans 40 mg potahované tablety
SE/H/0818/002 30/112/11-C VITABALANS OY CZ
Citalopram Vitabalans 20 mg plėvele dengtos tabletės
SE/H/0818/001 LT/1/11/2417/001 VITABALANS OY LT
Citalopram Vitabalans 40 mg plėvele dengtos tabletės
SE/H/0818/002 LT/1/11/2417/007 VITABALANS OY LT
Citalopram Vitabalans 20 mg plėvele dengtos tabletės
SE/H/0818/001 LT/1/11/2417/002 VITABALANS OY LT
Citalopram Vitabalans 20 mg plėvele dengtos tabletės
SE/H/0818/001 LT/1/11/2417/003 VITABALANS OY LT
List of nationally authorised medicinal products EMA/583896/2017 Page 79/93
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
Citalopram Vitabalans 20 mg plėvele dengtos tabletės
SE/H/0818/001 LT/1/11/2417/004 VITABALANS OY LT
Citalopram Vitabalans 20 mg plėvele dengtos tabletės
SE/H/0818/001 LT/1/11/2417/005 VITABALANS OY LT
Citalopram Vitabalans 20 mg plėvele dengtos tabletės
SE/H/0818/001 LT/1/11/2417/006 VITABALANS OY LT
Citalopram Vitabalans 40 mg plėvele dengtos tabletės
SE/H/0818/002 LT/1/11/2417/008 VITABALANS OY LT
Citalopram Vitabalans 40 mg plėvele dengtos tabletės
SE/H/0818/002 LT/1/11/2417/009 VITABALANS OY LT
Citalopram Vitabalans 40 mg plėvele dengtos tabletės
SE/H/0818/002 LT/1/11/2417/010 VITABALANS OY LT
Citalopram Vitabalans 40 mg plėvele dengtos tabletės
SE/H/0818/002 LT/1/11/2417/011 VITABALANS OY LT
Citalopram Vitabalans 40 mg plėvele dengtos tabletės
SE/H/0818/002 LT/1/11/2417/012 VITABALANS OY LT
Citalopram Vitabalans 20 mg filmtabletta
SE/H/0818/001 OGYI-T-21674/01 VITABALANS OY HU
Citalopram Vitabalans 40 mg filmtabletta
SE/H/0818/002 OGYI-T-21674/07 VITABALANS OY HU
Citalopram Vitabalans 20 mg filmtabletta
SE/H/0818/001 OGYI-T-21674/02 VITABALANS OY HU
Citalopram Vitabalans 20 mg filmtabletta
SE/H/0818/001 OGYI-T-21674/03 VITABALANS OY HU
Citalopram Vitabalans 20 mg filmtabletta
SE/H/0818/001 OGYI-T-21674/04 VITABALANS OY HU
List of nationally authorised medicinal products EMA/583896/2017 Page 80/93
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
Citalopram Vitabalans 20 mg filmtabletta
SE/H/0818/001 OGYI-T-21674/05 VITABALANS OY HU
Citalopram Vitabalans 20 mg filmtabletta
SE/H/0818/001 OGYI-T-21674/06 VITABALANS OY HU
Citalopram Vitabalans 40 mg filmtabletta
SE/H/0818/002 OGYI-T-21674/08 VITABALANS OY HU
Citalopram Vitabalans 40 mg filmtabletta
SE/H/0818/002 OGYI-T-21674/09 VITABALANS OY HU
Citalopram Vitabalans 40 mg filmtabletta
SE/H/0818/002 OGYI-T-21674/10 VITABALANS OY HU
Citalopram Vitabalans 40 mg filmtabletta
SE/H/0818/002 OGYI-T-21674/11 VITABALANS OY HU
Citalopram Vitabalans 40 mg filmtabletta
SE/H/0818/002 OGYI-T-21674/12 VITABALANS OY HU
Citalopram Vitabalans 20 mg filmsko obložene tablete
SE/H/0818/001 H/12/00395/001 VITABALANS OY SI
Citalopram Vitabalans 40 mg filmsko obložene tablete
SE/H/0818/002 H/12/00395/007 VITABALANS OY SI
Citalopram Vitabalans 20 mg filmsko obložene tablete
SE/H/0818/001 H/12/00395/002 VITABALANS OY SI
Citalopram Vitabalans 20 mg filmsko obložene tablete
SE/H/0818/001 H/12/00395/003 VITABALANS OY SI
Citalopram Vitabalans 40 mg filmsko obložene tablete
SE/H/0818/002 H/12/00395/008 VITABALANS OY SI
Citalopram Vitabalans 40 mg filmsko obložene tablete
SE/H/0818/002 H/12/00395/009 VITABALANS OY SI
Citalopram Vitabalans, 20 mg, tabletki powlekane
SE/H/0818/001 20322 VITABALANS OY PL
List of nationally authorised medicinal products EMA/583896/2017 Page 81/93
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
Citalopram Vitabalans, 40 mg, tabletki powlekane
SE/H/0818/002 20323 VITABALANS OY PL
Citalopram G.L. 10 mg - Filmtabletten
not available 1-24775 G.L. PHARMA GMBH AT
Citalopram G.L. 20 mg - Filmtabletten
not available 1-24774 G.L. PHARMA GMBH AT
Citalopram G.L. 40 mg - Filmtabletten
not available 1-24776 G.L. PHARMA GMBH AT
Citalopram Qualigen 20 mg comprimidos recubiertos con película
not available 70.893 QUALIGEN, S.L. ES
Citalopram Qualigen 30 mg comprimidos recubiertos con película
not available 70.894 QUALIGEN, S.L. ES
Citalopram 10 mg Tablets
not available PL 20075/0272 ACCORD HEALTHCARE LIMITED
UK
Citalopram 20 mg Tablets
not available PL 20075/0273 ACCORD HEALTHCARE LIMITED
UK
Citalopram 40 mg Tablets
not available PL 20075/0274 ACCORD HEALTHCARE LIMITED
UK
CITALOPRAM BIOGARAN 20 mg, comprimé pelliculé sécable
not available 3400958178528 BIOGARAN FR
CITALOPRAM BIOGARAN 20 mg, comprimé pelliculé sécable
not available 3400949179718 BIOGARAN FR
CITALOPRAM BIOGARAN 20 mg, comprimé pelliculé sécable
not available 3400930031353 BIOGARAN FR
CITALOPRAM BIOGARAN 20 mg, comprimé pelliculé sécable
not available 3400955011026 BIOGARAN FR
List of nationally authorised medicinal products EMA/583896/2017 Page 82/93
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
CITALOPRAM BIOGARAN 20 mg, comprimé pelliculé sécable
not available 3400930031360 BIOGARAN FR
CITALOPRAM BIOGARAN 20 mg, comprimé pelliculé sécable
not available 3400957762025 BIOGARAN FR
CITALOPRAM BIOGARAN 20 mg, comprimé pelliculé sécable
not available 3400922033167 BIOGARAN FR
Citalopram Q-Pharm 10 mg Filmtabletten
not available 90967.00.00 JUTA PHARMA GMBH DE
Citalopram Q-Pharm 20 mg Filmtabletten
not available 90968.00.00 JUTA PHARMA GMBH DE
Citalopram Q-Pharm 40 mg Filmtabletten
not available 90969.00.00 JUTA PHARMA GMBH DE
Citalopram 40mg/ml Oral Drops, solution
UK/H/1238/001 PL 20046/0053 FOCUS PHARMACEUTICALS LIMITED
UK
Citalopram 40mg/ml Oral Drops, solution
UK/H/1238/001 PA 1338/003/001 FOCUS PHARMACEUTICALS LIMITED
IE
Citalopram 10mg Tablets not available PL 06453/0056 ATHLONE LABORATORIES LIMITED
UK
Citalopram 20mg Tablets not available PL 06453/0057 ATHLONE LABORATORIES LIMITED
UK
Citalopram 40mg Tablets not available PL 06453/0058 ATHLONE LABORATORIES LIMITED
UK
Pram 20 mg-Konzentrat zur Herstellung einer Infusionslösung
not available 1-29270 G.L. PHARMA GMBH AT
Pram 40 mg-Konzentrat zur Herstellung einer Infusionslösung
not available 1-29271 G.L. PHARMA GMBH AT
Cipramil 10 mg filmuhúðaðar töflur
not available 970141 H. LUNDBECK A/S IS
Cipramil 20 mg filmuhúðaðar töflur
not available 920052 H. LUNDBECK A/S IS
List of nationally authorised medicinal products EMA/583896/2017 Page 83/93
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
ELOPRAM 20 mg compresse rivestite con film
not available 028681017 LUNDBECK ITALIA SPA, IT IT
ELOPRAM 20 mg compresse rivestite con film
not available 028681031 LUNDBECK ITALIA SPA, IT IT
ELOPRAM 40 mg compresse rivestite con film
not available 028681029 LUNDBECK ITALIA SPA, IT IT
ELOPRAM 40 mg/ml concentrato per soluzione per infusione
not available 028681043 LUNDBECK ITALIA SPA, IT IT
ELOPRAM 40 mg/ml gocce orali, soluzione
not available 028681056 LUNDBECK ITALIA SPA, IT IT
Cipramil 40 mg/ml Oral drops, solution.
not available PA 776/1/4 LUNDBECK LTD., IE IE
Cipramil, 20 mg, tabletki powlekane
not available 8015 H. LUNDBECK A/S PL
Cipramil 10 mg film-coated tablets
not available PA 776/1/1 LUNDBECK LTD., IE IE
Cipramil 20 mg film-coated tablets
not available PA 776/1/2 LUNDBECK LTD., IE IE
PRISDAL 20 mg comprimidos recubiertos con película
not available 60.884 LUNDBECK ESPANA, ES ES
PRISDAL 30 mg comprimidos recubiertos con película
not available 63.627 LUNDBECK ESPANA, ES ES
SEROPRAM 20 mg comprimidos recubiertos con película
not available 60.885 LUNDBECK ESPANA, ES ES
SEROPRAM 30 mg comprimidos recubiertos con película
not available 63.564 LUNDBECK ESPANA, ES ES
List of nationally authorised medicinal products EMA/583896/2017 Page 84/93
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
SEROPRAM 20 mg potahované tablety
not available 30/122/91-C H. LUNDBECK A/S CZ
SEROPRAM 40 mg/ml perorální kapky, roztok
not available 30/209/99-C H. LUNDBECK A/S CZ
Seropram 10mg - Filmtabletten
not available 1-19871 LUNDBECK AUSTRIA GMBH AT
Seropram 20mg - Filmtabletten
not available 1-19326 LUNDBECK AUSTRIA GMBH AT
Seropram 20 mg – Konzentrat zur Infusionsbereitung
not available 1-19815 LUNDBECK AUSTRIA GMBH AT
Seropram 40 mg – Konzentrat zur Infusionsbereitung
not available 1-19396 LUNDBECK AUSTRIA GMBH AT
Cipramil not available 13248 H. LUNDBECK A/S DK Cipramil not available 13249 H. LUNDBECK A/S DK Cipramil not available 19168 H. LUNDBECK A/S DK Cipramil not available 13250 H. LUNDBECK A/S DK SEROPRAM koncentrát pro přípravu infuzního roztoku
not available 30/794/92-C H. LUNDBECK A/S CZ
Cipramil 10 mg tabletter, filmdrasjerte
not available 8150 H. LUNDBECK A/S NO
Cipramil 20 mg tabletter, filmdrasjerte
not available 8151 H. LUNDBECK A/S NO
Cipramil 30 mg tabletter, filmdrasjerte
not available 97-2985 H. LUNDBECK A/S NO
Cipramil 40 mg tabletter, filmdrasjerte
not available 8152 H. LUNDBECK A/S NO
Cipramil® Drops 40 mg/ml, oral drops solution
not available PL 0458/0071 LUNDBECK LTD. GB UK
Cipramil® 20 mg, Filmtabletten
not available 43145.01.00 LUNDBECK GMBH, DE DE
List of nationally authorised medicinal products EMA/583896/2017 Page 85/93
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
Cipramil® 40 mg, Filmtabletten
not available 43145.02.00 LUNDBECK GMBH, DE DE
Cipramil® Infusionslösungskonzentrat 20 mg, Konzentrat zur Herstellung einer Infusionslösung
not available 43451.00.00 LUNDBECK GMBH, DE DE
Cipramil 20 mg apvalkotās tablets
not available 01-0421 H. LUNDBECK A/S LV
Cipramil 20 mg, õhukese polümeerikattega tabletid
not available 227098 H. LUNDBECK A/S EE
CIPRAMIL 20 mg filmomhulde tabletten
not available BE151261 LUNDBECK SA, BE BE
CIPRAMIL 40 mg/ml concentraat voor oplossing voor infusie
not available BE151164 LUNDBECK SA, BE BE
CIPRAMIL 20 mg comprimés pelliculés
not available BE151261 LUNDBECK SA - N.V. BE
CIPRAMIL 40 mg/ml solution à diluer pour perfusion
not available BE151164 LUNDBECK SA - N.V. BE
Citalopram Lundbeck 10 mg filmdragerade tabletter
not available 14271 H. LUNDBECK A/S SE
Citalopram Lundbeck 20 mg filmdragerade tabletter
not available 14272 H. LUNDBECK A/S SE
Cipramil 10 mg filmdragerade tabletter
not available 11660 H. LUNDBECK A/S SE
Cipramil 20 mg filmdragerade tabletter
not available 11661 H. LUNDBECK A/S SE
CIPRAMIL 20 mg comprimés pelliculés
not available BE151261 LUNDBECK SA, BE LU
List of nationally authorised medicinal products EMA/583896/2017 Page 86/93
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
CIPRAMIL 40 mg/ml solution à diluer pour perfusion
not available BE151164 LUNDBECK SA, BE LU
Cipramil 20 mg, filmomhulde tabletten 20 mg
not available RVG 19593 LUNDBECK B.V., NL NL
Cipramil 40 mg, filmomhulde tabletten 40 mg
not available RVG 19594 LUNDBECK B.V., NL NL
Cipramil 40 mg/ml druppels voor oraal gebruik, oplossing
not available RVG 22687 LUNDBECK B.V., NL NL
Sepram 10 mg tabletti, kalvopäällysteinen
not available 13378 H. LUNDBECK A/S FI
Sepram 20 mg tabletti, kalvopäällysteinen
not available 13379 H. LUNDBECK A/S FI
Sepram 30 mg tabletti, kalvopäällysteinen
not available 15871 H. LUNDBECK A/S FI
Sepram 40 mg tabletti, kalvopäällysteinen
not available 13380 H. LUNDBECK A/S FI
SEROPRAM 40 mg/ml gocce orali, soluzione
not available 028759049 LUNDBECK ITALIA SPA, IT IT
SEROPRAM 20 mg compresse rivestite con film
not available 028759013 LUNDBECK ITALIA SPA, IT IT
SEROPRAM 20 mg compresse rivestite con film
not available 028759037 LUNDBECK ITALIA SPA, IT IT
SEROPRAM 40 mg compresse rivestite con film
not available 028759025 LUNDBECK ITALIA SPA, IT IT
SEROPRAM 40 mg/ml concentrato per soluzione per infusione
not available 028759052 LUNDBECK ITALIA SPA, IT IT
List of nationally authorised medicinal products EMA/583896/2017 Page 87/93
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
SEROPRAM 20 mg/0,5 ml, solution à diluer pour perfusion
not available 561 558-0 LUNDBECK SAS FR
SEROPRAM 40 mg/1 ml, solution à diluer pour perfusion
not available 561 559-7 LUNDBECK SAS FR
SEROPRAM 40 mg/ml, solution buvable
not available 346 537-2 LUNDBECK SAS FR
Seropram 10 mg επικαλυμμένα με λεπτό υμένιο δισκία
not available 45651/23-12-2004 LUNDBECK HELLAS, GR GR
Seropram 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
not available 73634/23-12-2004 LUNDBECK HELLAS, GR GR
Seropram 40 mg επικαλυμμένα με λεπτό υμένιο δισκία
not available 73635/23-12-2004 LUNDBECK HELLAS, GR GR
Seropram 40 mg/ml Πόσιμες σταγόνες διάλυμα
not available 45649/23-12-2004 LUNDBECK HELLAS, GR GR
Seropram 40 mg/ml πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
not available 19734/21-5-2001 LUNDBECK HELLAS, GR GR
SEROPRAM 20 mg, comprimé pelliculé sécable
not available 338 336 -1 LUNDBECK SAS FR
SEROPRAM 20 mg, comprimé pelliculé sécable
not available 570 510 - 7 LUNDBECK SAS FR
Seropram not available 16117 H. LUNDBECK A/S CY Cipramil® 10 mg film-coated tablets
not available PL 0458/0057 LUNDBECK LTD. GB UK
Cipramil® 20 mg film-coated tablets
not available PL 0458/0058 LUNDBECK LTD. GB UK
List of nationally authorised medicinal products EMA/583896/2017 Page 88/93
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
Cipramil® 40 mg film-coated tablets
not available PL 0458/0059 LUNDBECK LTD. GB UK
Seropram 40 mg/ml koncentrátum oldatos infúzióhoz
not available OGYI-T-2100/03 LUNDBECK HUNGARIA KFT. HU
Seropram 20 mg filmtabletta
not available OGYI-T-2100/01 LUNDBECK HUNGARIA KFT. HU
Cipramil 20 mg filmsko obložene tablete
not available 5363-I-537/09 LUNDBECK PHARMA D.O.O SI
Серопрам 20 mg филмирани таблетки
not available 9600121 H. LUNDBECK A/S BG
Citalopram esparma 10 mg Filmtabletten
DE/H/1980/001 58947.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Citalopram esparma 20 mg Filmtabletten
DE/H/1980/002 58947.01.00 ARISTO PHARMA GMBH (ART 57)
DE
Citalopram esparma 40 mg Filmtabletten
DE/H/1980/003 58947.02.00 ARISTO PHARMA GMBH (ART 57)
DE
Pram, 20 mg, tabletki powlekane
not available 11052 G.L. PHARMA GMBH PL
CITALOPRAM ALMUS PHARMA 40 mg/ml gocce orali, soluzione
not available 036971012 ALMUS S.R.L IT
CITALOPRAM ALMUS 20 mg compresse rivestite con film
not available 036434013 ALMUS S.R.L IT
Далсан 20 mg филмирани таблетки
not available 20060570 EGIS PHARMACEUTICALS PLC
BG
Далсан 10 mg филмирани таблетки
not available 20060569 EGIS PHARMACEUTICALS PLC
BG
Далсан 40 mg филмирани таблетки
not available 20060571 EGIS PHARMACEUTICALS PLC
BG
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111147 RANBAXY ITALIA S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 89/93
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
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111186 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111198 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111200 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111174 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111111 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111135 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111123 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111162 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 20 mg compresse rivestite con film
UK/H/806/02/MR 037111150 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111034 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111251 RANBAXY ITALIA S.P.A. IT
Citalopram10 mg Film-coated Tablets
UK/H/0806/001 PL 14894 / 0163 RANBAXY UK LTD UK
List of nationally authorised medicinal products EMA/583896/2017 Page 90/93
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
Citalopram 20 mg Film-coated Tablets
UK/H/0806/002 PL 14894/0164 RANBAXY UK LTD UK
Citalopram 40 mg Film-coated Tablets
UK/H/0806/003 PL 14894/0165 RANBAXY UK LTD UK
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111046 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111085 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111061 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111109 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111073 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111097 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111022 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111059 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 10 mg compresse rivestite con film
UK/H/0806/001 037111010 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111212 RANBAXY ITALIA S.P.A. IT
List of nationally authorised medicinal products EMA/583896/2017 Page 91/93
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
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111224 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111236 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111248 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111263 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111287 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111301 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111275 RANBAXY ITALIA S.P.A. IT
Citalopram Ranbaxy 40 mg compresse rivestite con film
UK/H/806/03/MR 037111299 RANBAXY ITALIA S.P.A. IT
PRICITAL not available 40060/11-9-2008 LAVIPHARM HELLAS AE GR Citalopram Teva-Rimafar 20 mg comprimidos recubiertos con película EFG
not available 66508 TEVA PHARMA S.L.U ES
Citalopram Actavis 30 mg comprimidos revestidos por película
DE/H/1164/003 5136536 ACTAVIS GROUP PTC EHF. PT
List of nationally authorised medicinal products EMA/583896/2017 Page 92/93
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
Citalopram Aurovitas Spain 20 mg comprimidos recubiertos con película EFG
DE/H/1164/002 70440 AUROVITAS SPAIN,S.A.U. ES
Citalopram Aurovitas Spain 40 mg comprimidos recubiertos con película EFG
DE/H/1164/004 70438 AUROVITAS SPAIN,S.A.U. ES
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 5136460 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 10 mg comprimidos revestidos por película
DE/H/1164/001 5136478 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 5136502 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 20 mg comprimidos revestidos por película
DE/H/1164/002 5136510 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 5136544 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Aurovitas 40 mg comprimidos revestidos por película
DE/H/1164/004 5136551 AUROVITAS UNIPESSOAL, LDA.
PT
Citalopram Actavis 10 mg Filmtabletten
DE/H/1164/001 1-28112 ACTAVIS GROUP PTC EHF. AT
Citalopram-Actavis 10 mg Filmtabletten
DE/H/1164/001 69808.00.00 ACTAVIS GROUP PTC EHF. DE
Citalopram Actavis 20 mg Filmtabletten
DE/H/1164/002 1-28113 ACTAVIS GROUP PTC EHF. AT
Citalopram-Actavis 20 mg Filmtabletten
DE/H/1164/002 69809.00.00 ACTAVIS GROUP PTC EHF. DE
List of nationally authorised medicinal products EMA/583896/2017 Page 93/93
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
Citalopram Actavis 40 mg Filmtabletten
DE/H/1164/003 1-28115 ACTAVIS GROUP PTC EHF. AT
Citalopram-Actavis 40 mg Filmtabletten
DE/H/1164/004 69811.00.00 ACTAVIS GROUP PTC EHF. DE
Oropram 10 mg filmsko obloiene tablete
DE/H/1164/001 H/09/01191/001 ACTAVIS GROUP PTC EHF. SI
Oropram 20 mg filmsko obloiene tablete
DE/H/1164/002 H/09/01191/011 ACTAVIS GROUP PTC EHF. SI
Oropram 40 mg filmsko obloiene tablete
DE/H/1164/003 H/09/01191/022 ACTAVIS GROUP PTC EHF. SI
SELON not available 41577 GENEPHARM S.A. GR Selon not available 41578/20-10-2009 GENEPHARM S.A. GR Citalopram Farmaprojects 20 mg comprimidos recubiertos con película EFG
NOT APPLICABLE 66266 Farmaprojects S.A.U.
ES