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12 July 2018
EMA/612747/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products Active substance: paroxetine
Procedure no.: PSUSA/00002319/201712
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact An agency of the European Union
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
List of nationally authorised medicinal products EMA/608623/2018 Page 2/12
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
Парикс 40 mg таблетки not available 20150151 MEDOCHEMIE LTD. BG paroxedura 40 mg Tabletten NL/H/0450/004 66370.00.00 MYLAN DURA GMBH DE Paroxetine 10 mg Film-Coated Tablets not available PL 42357/0223 AMNEAL PHARMA EUROPE
LIMITED UK
SEROXAT 20 mg comprimate filmate not available 601/2008/01 SMITHKLINE BEECHAM LTD RO SEROXAT 20 mg comprimate filmate not available 601/2008/02 SMITHKLINE BEECHAM LTD RO SEREUPIN 20 mg compresse rivestite con film
not available 027965033 GLAXOSMITHKLINE S.P.A. IT
SEREUPIN 20 mg/10 ml sospensione orale
not available 027965021 GLAXOSMITHKLINE S.P.A. IT
СЕРОКСАТ 20 mg филмирани таблетки
not available 20000014 SMITHKLINE BEECHAM LTD BG
ПАРОКСАТ 20 mg филмирани таблетки
not available 20030653 GLAXOSMITHKLINE EOOD BG
SEROXAT 20 mg filmom obložene tablete
not available HR-H-051250245 GLAXOSMITHKLINE D.O.O. HR
SEROXAT 30 mg filmom obložene tablete
not available HR-H-284734421 GLAXOSMITHKLINE D.O.O. HR
Paroxetina STADAGEN 40 mg comprimidos
not available 76.032 LABORATORIO STADA, S.L. ES
Paroxetine EG 40 mg comprimés NL/H/0449/004 2010050086 EUROGENERICS N.V./S.A. LU Paroxetine EG 40 mg tabletten NL/H/0449/004 BE316197 EUROGENERICS N.V./S.A. BE Paroxetine EG 40 mg Tabletten NL/H/0449/004 BE316197 EUROGENERICS N.V./S.A. BE Paroxetine EG 40 mg comprimés NL/H/0449/004 BE316197 EUROGENERICS N.V./S.A. BE Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/002 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/029 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/031 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/034 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/032 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/033 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/036 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
List of nationally authorised medicinal products EMA/608623/2018 Page 3/12
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
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/037 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/039 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/038 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/040 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/041 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/043 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/046 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/045 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/044 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/047 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/050 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/049 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/051 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/048 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/053 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/035 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/042 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/030 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/052 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
List of nationally authorised medicinal products EMA/608623/2018 Page 4/12
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
Paluxon 40 mg filmsko obložene tablete
DK/H/0234/002 H/10/01211/054 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/02 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/03 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/04 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/05 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/06 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/07 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/08 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/09 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/10 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/11 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/12 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/13 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/14 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/15 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/16 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/17 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/19 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/20 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/21 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/22 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/23 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/24 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/25 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/26 S.C. SANDOZ S.R.L. RO Paluxetil 40 mg comprimate filmate DK/H/0234/002 4181/2012/01 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/28 S.C. SANDOZ S.R.L. RO PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/18 S.C. SANDOZ S.R.L. RO Paroxetin Sandoz 40 mg Filmtabletten DK/H/0234/002 51398.01.00 HEXAL AG DE Paroxetin - 1 A Pharma®40 mg Filmtabletten
DK/H/0236/002 51402.01.00 1 A PHARMA GMBH DE
Paroxetine Sandoz 40 mg filmomhulde tabletten
DK/H/0237/002 BE232285 SANDOZ N.V. BE
Paroxetine Sandoz 40 mg filmomhulde tabletten
DK/H/0237/002 BE232294 SANDOZ N.V. BE
Paroxetin - 1 A Pharma® 30 mg DK/H/0237/004 64768.00.00 1 A PHARMA GMBH DE
List of nationally authorised medicinal products EMA/608623/2018 Page 5/12
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
Filmtabletten Paroxetin - 1 A Pharma® 10 mg Filmtabletten
DK/H/0237/003 64767.00.00 1 A PHARMA GMBH DE
Paroxetin Sandoz® 30 mg Filmtabletten
DK/H/0234/004 64770.00.00 HEXAL AG DE
Paroc, filmovertrukne tabletter DK/H/0234/002 31771 HEXAL A/S DK Paroxetin ”1A Farma”, filmovertrukne tabletter
DK/H/0236/002 31775 1A FARMA A/S DK
Optipar DK/H/0237/002 31777 HEXAL A/S DK Paroc, filmovertrukne tabletter DK/H/0234/003 35319 HEXAL A/S DK Optipar DK/H/0237/003 35323 HEXAL A/S DK Optipar 40 mg tabletti, kalvopäällysteinen
DK/H/0237/002 16398 HEXAL A/S FI
PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/01 S.C. SANDOZ S.R.L. RO Paroxetina Pensa 20 mg comprimidos recubiertos con película EFG
not available 68.937 PENSA PHARMA, S.A ES
Paroxat®40 mg Filmtabletten DK/H/0233/002 51396.01.00 HEXAL AG DE Paroxat® 30 mg Filmtabletten DK/H/0233/004 64766.00.00 HEXAL AG DE Paroxat® 10 mg Filmtabletten DK/H/0233/003 64765.00.00 HEXAL AG DE Paroxat Hexal 40 mg - Filmtabletten DK/H/0233/002 1-24136 HEXAL PHARMA GMBH AT Paroxat Hexal 30 mg - Filmtabletten DK/H/0233/004 1-26609 HEXAL PHARMA GMBH AT Paroxat Hexal 10 mg - Filmtabletten DK/H/0233/003 1-26608 HEXAL PHARMA GMBH AT Paroxetin ”HEXAL”, filmovertrukne tabletter
DK/H/0233/002 31632 HEXAL A/S DK
Paroxetin ”HEXAL”, filmovertrukne tabletter
DK/H/0233/003 35317 HEXAL A/S DK
Paroxetina Aurovitas 30 mg comprimidos recubiertos con película
PT/H/1559/002 81.512 AUROVITAS SPAIN,S.A.U. ES
Paroxetine Aurobindo 30 mg film-coated tablets
PT/H/1559/002 MA807/09902 AUROBINDO PHARMA (MALTA) LIMITED
MT
Paroxetina STADAGEN 30 mg comprimidos
not available 76.031 LABORATORIO STADA, S.L. ES
Paroxetin beta 10 mg Tabletten DE/H/3070/001 66634.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Paroxetin beta 30 mg Tabletten DE/H/3070/003 66636.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Paroxetin beta 40 mg Tabletten DE/H/3070/004 66637.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/608623/2018 Page 6/12
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
Paroxetin-Hormosan 33,1 mg/ml Tropfen zum Einnehmen, Lösung
NL/H/0877/001 67595.00.00 HORMOSAN PHARMA GMBH DE
Парикс 40 mg таблетки not available 20150151 MEDOCHEMIE LTD. BG Paroxetine 10 mg Film-coated Tablets not available PL 30322/0025 ALISSA HEALTHCARE
RESEARCH LIMITED UK
Paroxetine 20 mg Film-coated Tablets not available PL 30322/0026 ALISSA HEALTHCARE RESEARCH LIMITED
UK
Paroxetine 30 mg Film-coated Tablets not available PL 30322/0027 ALISSA HEALTHCARE RESEARCH LIMITED
UK
Paroxetine 40 mg Film-coated Tablets not available PL 30322/0028 ALISSA HEALTHCARE RESEARCH LIMITED
UK
Seroxat 20 mg filmtabletta NL/H/0566/001 OGYI-T-4107/01 GLAXOSMITHKLINE KFT. HU Seroxat 20 mg filmtabletta NL/H/0566/001 OGYI-T-4107/03 GLAXOSMITHKLINE KFT. HU Seroxat 20 mg tablet, filmomhulde tabletten
NL/H/0566/01 RVG 14668 GLAXOSMITHKLINE B.V. NL
Seroxat 30 mg tablet, filmomhulde tabletten
NL/H/0566/02 RVG 27135 GLAXOSMITHKLINE B.V. NL
Seroxat Suspensie 2 mg/ml, suspensie voor oraal gebruik
NL/H/0566/003 RVG 20557 GLAXOSMITHKLINE B.V. NL
SEROXAT 20 mg film-coated tablets NL/H/0566/01 MA 172/00201 SMITHKLINE BEECHAM LTD MT Seroxat 20 mg filmdragerad tablett NL/H/0566/01 10814 SMITHKLINE BEECHAM LTD FI SEROXAT 20 mg, Filmtabletten NL/H/0566/001 BE159774 GLAXOSMITHKLINE
PHARMACEUTICALS SA BE
SEROXAT 20 mg filmomhulde tabletten NL/H/0566/001 BE285354 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 20 mg, Filmtabletten NL/H/0566/001 BE285354 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 30 mg filmomhulde tabletten NL/H/0566/002 BE285363 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 30 mg, Filmtabletten NL/H/0566/002 BE285363 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 30 mg filmomhulde tabletten NL/H/0566/002 BE285372 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 30 mg, Filmtabletten NL/H/0566/002 BE285372 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 30 mg, Filmtabletten Paroxetin (als Hydrochlorid-Hemihydrat)
NL/H/0566/002 2011 04 1084 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
List of nationally authorised medicinal products EMA/608623/2018 Page 7/12
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
SEROXAT 20 mg, Filmtabletten Paroxetin (als Hydrochlorid-Hemihydrat)
NL/H/0566/001 2011 04 1083 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/002 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/003 GLAXOSMITHKLINE D.O.O. SI
SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/004 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/005 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/006 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/007 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/008 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/009 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/010 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/011 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/012 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/013 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/014 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/029 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/030 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/031 GLAXOSMITHKLINE D.O.O. SI
SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/01 H/00/01408/032 GLAXOSMITHKLINE D.O.O. SI
SEROXAT 20 mg filmsko obložene NL/H/0566/01 H/00/01408/033 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products EMA/608623/2018 Page 8/12
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
tablete SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/01 H/00/01408/034 GLAXOSMITHKLINE D.O.O. SI
SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/01 H/00/01408/035 GLAXOSMITHKLINE D.O.O. SI
SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/01 H/00/01408/036 GLAXOSMITHKLINE D.O.O. SI
SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/01 H/00/01408/037 GLAXOSMITHKLINE D.O.O. SI
SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/01 H/00/01408/038 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/039 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/040 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmsko obložene tablete
NL/H/0566/001 H/00/01408/041 GLAXOSMITHKLINE D.O.O. SI
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/002 H/00/01408/043 GLAXOSMITHKLINE D.O.O. SI
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/002 H/00/01408/044 GLAXOSMITHKLINE D.O.O. SI
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/002 H/00/01408/045 GLAXOSMITHKLINE D.O.O. SI
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/002 H/00/01408/050 GLAXOSMITHKLINE D.O.O. SI
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/002 H/00/01408/051 GLAXOSMITHKLINE D.O.O. SI
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/002 H/00/01408/052 GLAXOSMITHKLINE D.O.O. SI
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/02 H/00/01408/053 GLAXOSMITHKLINE D.O.O. SI
Seroxat 2 mg/ml – Suspension zum Einnehmen
NL/H/0566/003 1-22309 GLAXOSMITHKLINE PHARMA GMBH.
AT
DEROXAT 20 mg/10 ml, suspension buvable
NL/H/0566/03 NL22372 LABORATOIRE GLAXOSMITHKLINE
FR
Seroxat® 2 mg/ml Suspension zum Einnehmen
NL/H/0566/003 44028.00.01 GLAXOSMITHKLINE GMBH & CO. KG
DE
SEROXAT 20 mg/10ml πόσιμο NL/H/0566/003 2017403 GLAXOSMITHKLINE AEBE GR
List of nationally authorised medicinal products EMA/608623/2018 Page 9/12
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
εναιώρημα SEROXAT 20 mg/10 ml oral suspension NL/H/0566/003 PA 1077/97/1 GLAXOSMITHKLINE
(IRELAND) LIMITED IE
SEROXAT 2 mg/ml sospensione orale NL/H/0566/003 027963026 GLAXOSMITHKLINE S.P.A. IT Seroxat Suspensie 2 mg/ml, suspensie voor oraal gebruik
NL/H/0566/003 RVG20557 GLAXOSMITHKLINE B.V. NL
Seroxat® 20 mg/10 ml oral suspension NL/H/0566/003 10592/0092 SMITHKLINE BEECHAM LTD UK Seroxat 10 mg filmuhúðaðar töflur NL/H/0566/004 IS/1/05/011/01 GLAXOSMITHKLINE PHARMA
A/S IS
SEROXAT 10 mg film-coated tablets NL/H/0566/004 PA 1077/97/4 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Seroxat 10 mg plėvele dengtos tabletės
NL/H/0566/004 LT/1/06/0597/027 GLAXOSMITHKLINE LIETUVA UAB
LT
Seroxat 10 mg plėvele dengtos tabletės
NL/H/0566/004 LT/1/06/0597/028 GLAXOSMITHKLINE LIETUVA UAB
LT
Seroxat 10 mg tablet, filmomhulde tabletten
NL/H/0566/004 RVG 29433 GLAXOSMITHKLINE B.V. NL
Seroxat 10 mg tablett, filmdrasjert NL/H/0566/004 03-1911 GLAXOSMITHKLINE AS NO Seroxat 10 mg filmom obalené tablety NL/H/0566/004 30/0477/07-S GLAXOSMITHKLINE
SLOVAKIA S.R.O. SK
Seroxat® 10 mg film-coated tablets NL/H/0566/04 10592/0218 SMITHKLINE BEECHAM LTD UK Seroxat 20 mg - Filmtabletten NL/H/0566/001 1-19931 GLAXOSMITHKLINE PHARMA
GMBH. AT
SEROXAT 20 mg comprimés pelliculés NL/H/0566/001 BE159774 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 20 mg comprimés pelliculés NL/H/0566/001 BE285354 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
SEROXAT 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
NL/H/0566/01 14178 SMITHKLINE BEECHAM LTD CY
Seroxat 20 mg potahované tablety NL/H/0566/001 30/490/96-A/C SMITHKLINE BEECHAM LTD CZ Seroxat NL/H/0566/001 13893 GLAXOSMITHKLINE PHARMA
A/S DK
SEROXAT, 20 mg õhukese polümeerikattega tabletid
NL/H/0566/001 161197 SMITHKLINE BEECHAM LTD EE
Seroxat 20 mg tabletti, kalvopäällysteinen
NL/H/0566/01 10814 SMITHKLINE BEECHAM LTD FI
DEROXAT 20 mg, comprimé pelliculé sécable
NL/H/0566/01 NL16996 LABORATOIRE GLAXOSMITHKLINE
FR
List of nationally authorised medicinal products EMA/608623/2018 Page 10/12
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
Seroxat® 20 mg Filmtabletten NL/H/0566/001 44028.00.00 GLAXOSMITHKLINE GMBH & CO. KG
DE
SEROXAT 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
NL/H/0566/01 2017401 GLAXOSMITHKLINE AEBE GR
SEROXAT 20 mg film-coated tablets NL/H/0566/001 PA 1077/97/2 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Seroxat 20 mg filmuhúðaðar töflur NL/H/0566/001 900044 GLAXOSMITHKLINE PHARMA A/S
IS
SEROXAT 20 mg compresse rivestite con film
NL/H/0566/001 027963014 GLAXOSMITHKLINE S.P.A. IT
SEROXAT 20 mg compresse rivestite con film
NL/H/0566/001 027963038 GLAXOSMITHKLINE S.P.A. IT
SEROXAT 20 mg compresse rivestite con film
NL/H/0566/001 027963040 GLAXOSMITHKLINE S.P.A. IT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/001 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/002 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/003 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/004 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/005 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/006 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/007 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/008 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/009 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/010 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/011 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/012 SMITHKLINE BEECHAM LTD LT
List of nationally authorised medicinal products EMA/608623/2018 Page 11/12
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
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/013 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/029 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/030 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/031 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/032 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/033 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/034 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/035 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/036 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/037 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/038 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/039 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/040 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/041 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/042 SMITHKLINE BEECHAM LTD LT
Seroxat 20 mg plėvele dengtos tabletės
NL/H/0566/001 LT/1/06/0597/043 SMITHKLINE BEECHAM LTD LT
SEROXAT 20 mg comprimés pelliculés NL/H/0566/001 2011 04 1083 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
SEROXAT 20 mg apvalkotās tabletes NL/H/0566/01 99-1041 GLAXOSMITHKLINE LATVIA SIA
LV
Seroxat 20 mg tablett, filmdrasjert NL/H/0566/001 00-7840 GLAXOSMITHKLINE AS NO Seroxat, 20 mg, tabletki powlekane NL/H/0566/001 R/6405 GLAXOSMITHKLINE EXPORT PL
List of nationally authorised medicinal products EMA/608623/2018 Page 12/12
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
LTD SEROXAT 20 mg comprimidos revestidos por película
NL/H/0566/001 2313484 GLAXOSMITHKLINE - PRODUTOS FARMACEUTICOS, LIMITADA
PT
SEROXAT 20 mg comprimidos revestidos por película
NL/H/0566/001 2313385 GLAXOSMITHKLINE - PRODUTOS FARMACEUTICOS, LDA
PT
SEROXAT 20 mg comprimidos revestidos por película
NL/H/0566/001 5053780 GLAXOSMITHKLINE - PRODUTOS FARMACEUTICOS, LIMITADA
PT
Seroxat 20 mg comprimidos recubiertos con película
NL/H/0566/01 59.468 GLAXOSMITHKLINE, S.A. ES
Seroxat 20 mg filmom obalené tablety NL/H/0566/001 30/0859/95-S GLAXOSMITHKLINE SLOVAKIA S.R.O.
SK
SEROXAT 20 mg filmsko obložene tablete
NL/H/0566/01 H/00/01408/001 GLAXOSMITHKLINE D.O.O. SI
Seroxat 20 mg filmdragerad tablett NL/H/0566/01 11376 GLAXOSMITHKLINE AB SE Seroxat® 20 mg film-coated tablets NL/H/0566/001 10592/0001 SMITHKLINE BEECHAM LTD UK SEROXAT 30 mg comprimés pelliculés NL/H/0566/002 BE285363 GLAXOSMITHKLINE
PHARMACEUTICALS SA BE
SEROXAT 30 mg comprimés pelliculés NL/H/0566/002 BE285372 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Seroxat 30 mg potahované tablety NL/H/0566/02 30/490/96-B/C SMITHKLINE BEECHAM LTD CZ Seroxat NL/H/0566/002 33651 GLAXOSMITHKLINE PHARMA
A/S DK
SEROXAT 30 mg επικαλυμμένα με λεπτό υμένιο δισκία
NL/H/0566/002 2017402 GLAXOSMITHKLINE AEBE GR
SEROXAT 30 mg film-coated tablets NL/H/0566/002 PA 1077/97/3 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Seroxat 30 mg plėvele dengtos tabletės
NL/H/0566/002 LT/1/06/0597/018 SMITHKLINE BEECHAM LTD LT
Seroxat 30 mg plėvele dengtos tabletės
NL/H/0566/002 LT/1/06/0597/019 SMITHKLINE BEECHAM LTD LT
Seroxat 30 mg plėvele dengtos tabletės
NL/H/0566/002 LT/1/06/0597/021 SMITHKLINE BEECHAM LTD LT
Seroxat 30 mg plėvele dengtos tabletės
NL/H/0566/002 LT/1/06/0597/022 SMITHKLINE BEECHAM LTD LT
Seroxat 30 mg plėvele dengtos NL/H/0566/002 LT/1/06/0597/044 SMITHKLINE BEECHAM LTD LT
List of nationally authorised medicinal products EMA/608623/2018 Page 13/12
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
tabletės Seroxat 30 mg plėvele dengtos tabletės
NL/H/0566/002 LT/1/06/0597/045 SMITHKLINE BEECHAM LTD LT
Seroxat 30 mg plėvele dengtos tabletės
NL/H/0566/002 LT/1/06/0597/046 SMITHKLINE BEECHAM LTD LT
Seroxat 30 mg plėvele dengtos tabletės
NL/H/0566/002 LT/1/06/0597/047 SMITHKLINE BEECHAM LTD LT
SEROXAT 30 mg comprimés pelliculés NL/H/0566/002 2011 04 1084 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Seroxat 30 mg filmom obalené tablety NL/H/0566/002 30/0339/06-S GLAXOSMITHKLINE SLOVAKIA S.R.O.
SK
Seroxat 30 mg filmsko obložene tablete
NL/H/0566/002 H/00/01408/042 GLAXOSMITHKLINE D.O.O. SI
Seroxat® 30 mg film-coated tablets NL/H/0566/002 10592/0002 SMITHKLINE BEECHAM LTD UK SOLBEN 40mg δισκία NL/H/0450/004 32477/8-4-2014 GAP S.A. GR Paroxetine 40 mg, tabletten NL/H/0450/004 RVG 33137 ICC B.V. NL Paroxetine GSK 20 mg tablet, filmomhulde tabletten
NL/H/0568/01 RVG 30169 GLAXOSMITHKLINE B.V. NL
Motivan 20 mg comprimidos recubiertos con película
NL/H/0568/01 59.535 GLAXOSMITHKLINE, S.A. ES
Daparox 20 mg comprimidos recubiertos con película
ES/H/0406/001 65.259 ANGELINI FARMACEUTICA, S.A.
ES
Paroxetine 20 mg Tablets not available PL 40378/0101 APTIL PHARMA LIMITED UK Paroxetine 30 mg Tablets not available PL 40378/0102 APTIL PHARMA LIMITED UK Paroxetina Mabo 30 mg, comprimidos NL/H/0831/003 68508 MABO-FARMA, S.A. ES Paroxetina Mabo 40 mg, comprimidos NL/H/0831/004 68509 MABO-FARMA, S.A. ES Paroxetine 40 mg, tabletten NL/H/0831/004 RVG 33148 ICC B.V. NL Syntopar 10 mg, δισκία NL/H/0831/001 20195 CODAL SYNTO LTD CY Syntopar 40 mg, δισκία NL/H/0831/004 20198 CODAL SYNTO LTD CY Paroxetin-neuraxpharm 10 mg Tabletten
not available 61351.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Paroxetin-neuraxpharm 30 mg Tabletten
not available 61353.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Paroxetin-neuraxpharm 40 mg Tabletten
not available 61354.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Paroxetin Aurobindo 30 mg Filmtabletten
DK/H/1135/002 68269.00.00 AUROBINDO PHARMA GMBH DE
Paroxetina Aurobindo 30 mg DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA PT
List of nationally authorised medicinal products EMA/608623/2018 Page 14/12
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
comprimidos revestidos por película (PORTUGAL), UNIPESSOAL LDA
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Paroxetina Aurobindo 30 mg comprimidos revestidos por película
DK/H/1135/002 DK/H/1135/002 AUROBINDO PHARMA (PORTUGAL), UNIPESSOAL LDA
PT
Парикс 40 mg таблетки not available 20150151 MEDOCHEMIE LTD. BG Parogen 20 mg filmsko obložene tablete
not available H/04/01232/002 GENERICS [UK] LIMITED SI
Parogen 20 mg filmsko obložene not available H/04/01232/001 GENERICS [UK] LIMITED SI
List of nationally authorised medicinal products EMA/608623/2018 Page 15/12
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
tablete paroxetina cinfa 20 mg comprimidos recubiertos con película EFG
not available 66.932 LABORATORIOS CINFA, S.A. ES
Paroxetine EG 20 mg filmomhulde tabletten
DK/H/0240/001 BE227717 EUROGENERICS N.V./S.A. BE
Paroxetine EG 20 mg filmomhulde tabletten
DK/H/0240/001 BE227701 EUROGENERICS N.V./S.A. BE
Paroxetine EG 20 mg filmomhulde tabletten
DK/H/0240/001 BE269062 EUROGENERICS N.V./S.A. BE
Paroxetine EG 20 mg Filmtabletten DK/H/0240/001 BE227717 EUROGENERICS N.V./S.A. BE Paroxetine EG 20 mg Filmtabletten DK/H/0240/001 BE227701 EUROGENERICS N.V./S.A. BE Paroxetine EG 20 mg Filmtabletten DK/H/0240/001 BE269062 EUROGENERICS N.V./S.A. BE Paroxetine EG 20 mg comprimés pelliculés
DK/H/0240/001 BE269062 EUROGENERICS N.V./S.A. BE
Paroxetine EG 20 mg comprimés pelliculés
DK/H/0240/001 BE227701 EUROGENERICS N.V./S.A. BE
Paroxetine EG 20 mg comprimés pelliculés
DK/H/0240/001 BE227717 EUROGENERICS N.V./S.A. BE
Ennos 20 mg-Filmtabletten DK/H/0240/001 1-24116 G.L. PHARMA GMBH AT DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444138 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444126 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444025 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444037 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444049 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444052 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444064 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444076 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444088 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite DK/H/0240/001 035444090 SYNTHON BV IT
List of nationally authorised medicinal products EMA/608623/2018 Page 16/12
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
con film DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444102 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444114 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444153 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444165 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444140 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444189 SYNTHON BV IT
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444177 SYNTHON BV IT
Daparox 33,1 mg/ml, gocce orali, soluzione
DK/H/0240/002 035444203 SYNTHON BV IT
Daparox 33,1 mg/ml, gocce orali, soluzione
DK/H/0240/002 035444191 SYNTHON BV IT
Euplix, orale dråber, opløsning DK/H/0240/002 38097 SYNTHON BV DK Paroxetine 20 mg, Filmomhulde tabletten
DK/H/0240/001 RVG 26382 GENTHON BV NL
DAPAROX 20 mg compresse rivestite con film
DK/H/0240/001 035444013 SYNTHON BV IT
Euplix 20 mg Filmtabletten DK/H/0240/001 51352.00.00 SYNTHON BV DE Euplix 20 mg filmovertrukne tabletter DK/H/0240/001 31126 (D.SP.NR. 20241) SYNTHON BV DK Paroxetin ratiopharm 40 mg Tabletten NL/H/0453/001 1-26740 TEVA B.V AT Paroxetin-ratiopharm® 40 mg Tabletten
NL/H/0453/001 66377.00.00 RATIOPHARM GMBH DE
Paroxetine 40 mg, tabletten NL/H/0453/001 RVG 33151 RATIOPHARM GMBH NL Paroxetine 20 mg tablet GSK, filmomhulde tabletten
NL/H/0569/001 RVG 30172 GLAXOSMITHKLINE B.V. NL
DIVARIUS 20 mg, comprimé pelliculé sécable
not available 360 795-5 CHIESI S.A.S. FR
DIVARIUS 20 mg, comprimé pelliculé sécable
not available 360 796-1 CHIESI S.A.S. FR
DIVARIUS 20 mg, comprimé pelliculé sécable
not available 564 273-7 CHIESI S.A.S. FR
List of nationally authorised medicinal products EMA/608623/2018 Page 17/12
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
DIVARIUS 20 mg, comprimé pelliculé sécable
not available 360 112-5 CHIESI S.A.S. FR
DIVARIUS 20 mg, comprimé pelliculé sécable
not available 360 113-1 CHIESI S.A.S. FR
DIVARIUS 20 mg, comprimé pelliculé sécable
not available 564 272-0 CHIESI S.A.S. FR
Paroxat 20 mg filmtabletta NL/H/0567/001 OGYI-T-8263/01 GLAXOSMITHKLINE KFT. HU Paroxat 20 mg filmtabletta NL/H/0567/01 OGYI-T-8263/03 GLAXOSMITHKLINE KFT. HU Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/002 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/003 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/004 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/005 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/006 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/007 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/008 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/009 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/010 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/011 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/012 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/013 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/027 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/028 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/029 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/030 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/031 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/032 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/033 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/01 H/04/01234/034 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/035 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/036 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/037 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/038 GLAXOSMITHKLINE D.O.O. SI Paroxat 20 mg filmsko obložene tablete NL/H/0567/001 H/04/01234/039 GLAXOSMITHKLINE D.O.O. SI Paroxat 30 mg filmsko obložene tablete NL/H/0567/02 H/04/01234/041 GLAXOSMITHKLINE D.O.O. SI Paroxat 30 mg filmsko obložene tablete NL/H/0567/02 H/04/01234/042 GLAXOSMITHKLINE D.O.O. SI Paroxat 30 mg filmsko obložene tablete NL/H/0567/02 H/04/01234/043 GLAXOSMITHKLINE D.O.O. SI Paroxat 30 mg filmsko obložene tablete NL/H/0567/02 H/04/01234/048 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products EMA/608623/2018 Page 18/12
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
Paroxat 30 mg filmsko obložene tablete NL/H/0567/02 H/04/01234/049 GLAXOSMITHKLINE D.O.O. SI Paroxat 30 mg filmsko obložene tablete NL/H/0567/02 H/04/01234/050 GLAXOSMITHKLINE D.O.O. SI Paroxat 30 mg filmsko obložene tablete NL/H/0567/02 H/04/01234/051 GLAXOSMITHKLINE D.O.O. SI PAROXETINE BIOGARAN 20 mg, comprimé pelliculé sécable
NL/H/0567/01 NL16997 LABORATOIRE GLAXOSMITHKLINE
FR
EUTIMIL 20 mg compresse rivestite con film
NL/H/0567/001 027964016 GLAXOSMITHKLINE S.P.A. IT
EUTIMIL 20 mg compresse rivestite con film
NL/H/0567/001 027964030 GLAXOSMITHKLINE S.P.A. IT
EUTIMIL 20 mg compresse rivestite con film
NL/H/0567/001 027964042 GLAXOSMITHKLINE S.P.A. IT
Paroxetine GSK 20 mg, filmomhulde tabletten
NL/H/0567/01 RVG 30166 GLAXOSMITHKLINE B.V. NL
Paroxat 20 mg filmsko obložene tablete NL/H/0567/01 H/04/01234/001 GLAXOSMITHKLINE D.O.O. SI Frosinor 20 mg comprimidos recubiertos con película
NL/H/0567/001 59.466 GLAXOSMITHKLINE, S.A. ES
Paroxetine GSK 30 mg, filmomhulde tabletten
NL/H/0567/02 RVG 30167 GLAXOSMITHKLINE B.V. NL
PAROXAT 30 mg filmsko obložene tablete
NL/H/0567/02 H/04/01234/040 GLAXOSMITHKLINE D.O.O. SI
Paroxetine GSK suspensie 2 mg/ml, suspensie voor oraal gebruik
NL/H/0567/03 RVG 30168 GLAXOSMITHKLINE B.V. NL
EUTIMIL 2 mg/ml sospensione orale NL/H/0567/03 027964028 GLAXOSMITHKLINE S.P.A. IT Paroxetine GSK 10 mg, filmomhulde tabletten
NL/H/0567/004 RVG 31988 GLAXOSMITHKLINE B.V. NL
PAROXAT 20 mg filmsko obložene tablete
NL/H/0567/01 H/04/01234/052 GLAXOSMITHKLINE D.O.O. SI
Paroxetin-ratiopharm® 40 mg Tabletten
not available 2012050049 RATIOPHARM GMBH LU
SOLBEN 40mg δισκία NL/H/0450/004 32477/8-4-2014 GAP S.A. GR Paroxetine 40 mg, tabletten NL/H/0450/004 RVG 33137 ICC B.V. NL Paroxetine 20 mg Film-Coated Tablets not available PL 20416/0355 CRESCENT PHARMA LIMITED UK Paroxetine 40 mg Film-Coated Tablets not available PL 20416/0363 CRESCENT PHARMA LIMITED UK Dropax 10mg/ml gotas orais, solução IT/H/0136/001 5928486 ITALFARMACO - PRODUTOS
FARMACÊUTICOS, LDA. PT
Paroxetine 40 mg Tablets not available PL11311/0403 TILLOMED LABORATORIES LTD
UK
Paroxia 40 mg, δισκία NL/H/0449/004 45309/1-7-2015 MEDOCHEMIE HELLAS SA GR
List of nationally authorised medicinal products EMA/608623/2018 Page 19/12
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
Paroxetine 40 mg, tabletten NL/H/0449/004 RVG 31774 ICC B.V. NL Arketis 10 mg, δισκία NL/H/0449/001 20185 MEDOCHEMIE LTD. CY Arketis 40 mg, δισκία NL/H/0449/004 20190 MEDOCHEMIE LTD. CY ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/001 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/002 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/003 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/004 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/005 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/006 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/007 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/008 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/009 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/010 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/021 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/022 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/023 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/024 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/025 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/026 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/027 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/028 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/029 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/030 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/031 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/032 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/033 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/034 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/035 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/036 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/037 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/038 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/039 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/040 MEDOCHEMIE LTD. LT Arketis 10 mg, tablets NL/H/0449/001 MA032/06601 MEDOCHEMIE LTD. MT Arketis 30 mg, tablets NL/H/0449/003 MA032/06603 MEDOCHEMIE LTD. MT Arketis 40 mg, tablets NL/H/0449/004 MA032/06604 MEDOCHEMIE LTD. MT Paroxetine 20 mg Tablets not available PL11311/0402 TILLOMED LABORATORIES UK
List of nationally authorised medicinal products EMA/608623/2018 Page 20/12
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
LTD Paroxetine 20 mg film-coated tablets not available PL21880/0056 MEDREICH PLC UK Paroxetine 30 mg film-coated tablets not available PL21880/0057 MEDREICH PLC UK Paroxia 40 mg, δισκία NL/H/0449/004 45309/1-7-2015 MEDOCHEMIE HELLAS SA GR Paroxetine 40 mg, tabletten NL/H/0449/004 RVG 31774 ICC B.V. NL Arketis 10 mg, δισκία NL/H/0449/001 20185 MEDOCHEMIE LTD. CY Arketis 40 mg, δισκία NL/H/0449/004 20190 MEDOCHEMIE LTD. CY ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/001 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/002 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/003 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/004 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/005 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/006 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/007 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/008 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/009 MEDOCHEMIE LTD. LT ARKETIS 10 mg tabletės NL/H/0449/001 LT/1/07/0679/010 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/021 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/022 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/023 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/024 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/025 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/026 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/027 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/028 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/029 MEDOCHEMIE LTD. LT ARKETIS 30 mg tabletes NL/H/0449/003 LT/1/07/0679/030 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/031 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/032 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/033 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/034 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/035 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/036 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/037 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/038 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/039 MEDOCHEMIE LTD. LT ARKETIS 40 mg tabletės NL/H/0449/004 LT/1/07/0679/040 MEDOCHEMIE LTD. LT
List of nationally authorised medicinal products EMA/608623/2018 Page 21/12
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
Arketis 10 mg, tablets NL/H/0449/001 MA032/06601 MEDOCHEMIE LTD. MT Arketis 30 mg, tablets NL/H/0449/003 MA032/06603 MEDOCHEMIE LTD. MT Arketis 40 mg, tablets NL/H/0449/004 MA032/06604 MEDOCHEMIE LTD. MT Paroxetine ICC 40 mg, tabletten not available RVG 100091 ICC B.V. NL Paroxetina Aurobindo 30 mg comprimidos recubiertos con película
not available 73471 LABORATORIOS AUROBINDO S.L.U.
ES
Paroxetine GlaxoSmithKline 20 mg, filmomhulde tabletten
NL/H/0592/001 RVG 32173 GLAXOSMITHKLINE B.V. NL