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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.

paroxetine: list of nationally authorised medicinal ... · PALUXETIL 40 mg comprimate filmate DK/H/0234/002 4181/2012/18 S.C. SANDOZ S.R.L. RO Paroxetin Sandoz 40 mg Filmtabletten

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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