# C_2005118EN.01000101.xml

| 19.5.2005 | EN | Official Journal of the European Union | C 118/1 |
| --- | --- | --- | --- |

19.5.2005

EN

Official Journal of the European Union

C 118/1

---

SUMMARY OF COMMUNITY DECISIONS ON MARKETING AUTHORISATIONS IN RESPECT OF MEDICINAL PRODUCTS FROM15.3.2005TO15.4.2005

SUMMARY OF COMMUNITY DECISIONS ON MARKETING AUTHORISATIONS IN RESPECT OF MEDICINAL PRODUCTS FROM

TO

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1

2

(2005/C 118/01)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 29.3.2005 | Paroxetine | See Annex I | See Annex I | 31.3.2005 |
| 29.3.2005 | Doramectin | See Annex II | See Annex II | 1.4.2005 |
| 29.3.2005 | Artirem | See Annex III | See Annex III | 1.4.2005 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

29.3.2005

Paroxetine

See Annex I

See Annex I

31.3.2005

29.3.2005

Doramectin

See Annex II

See Annex II

1.4.2005

29.3.2005

Artirem

See Annex III

See Annex III

1.4.2005

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(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

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ANNEX I

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AUSTRIA | Gerot Pharmazeutika GesmbH
  Arnethgasse 3
  A-1160 Wien | Allenopar 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Allen Pharmazeutika GesmbH
  Albert Schweitzer Gasse 6
  A-1140 Wien | Paroxetin ‘Allen’ 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Arcana Arzneimittel GmbH
  Zimbagasse 5
  A-1147 Wien | Paroxetin ‘Arcana’ 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Sandoz GmbH
  Biochemiestraße 10
  A-6250 Kundl/Tirol | Paluxetil 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Pharma GmbH
  Albert Schweitzer Gasse 6
  A-1140 Wien | Seroxat 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Pharma GmbH
  Albert Schweitzer Gasse 6
  A-1140 Wien | Seroxat 2 mg/ml — oral suspension | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline Pharma GmbH
  Albert Schweitzer Gasse 6
  A-1140 Wien | Glaxopar 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Pharma GmbH
  Albert Schweitzer Gasse 6
  A-1140 Wien | Paroglax 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Pharma GmbH
  Albert Schweitzer Gasse 6
  A-1140 Wien | Paroxetin ‘GSK’ 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Hexal Pharma GmbH
  Wilhelminestraße 91/IIf/3
  A-1160 Wien | Paroxat 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Hexal Pharma GmbH
  Wilhelminestraße 91/IIf/3
  A-1160 Wien | Paroxat 40 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Interpharm Produktions GmbH
  Effingergasse 21
  A-1160 Wien | Paroxetin ‘Interpharm’ Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Lannacher Heilmittel GmbH
  Schlossplatz 1
  A-8502 Lannach | Ennos 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm Arzneimittel Vertriebs — GmbH
  Albert Schweitzer Gasse 3
  A-1140 Wien | Paroxetin ‘Merckle’ 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm Arzneimittel Vertriebs — GmbH
  Albert Schweitzer Gasse 3
  A-1140 Wien | Paroxetin ‘ratiopharm’ 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Stada Arzneimittel GmbH
  Heiligenstädter Str. 52
  A-1190 Wien | Parocetan 20 mg — Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| BELGIUM | Bexal
  Av J. Bordet 168
  B-1140 Brussels | Paroxetine Bexal 20 mg | 20 mg | Film-coated tablet | Oral use |
| Bexal
  Av J. Bordet 168
  B-1140 Brussels | Paroxetine Bexal 40 mg | 40 mg | Film-coated tablet | Oral use |
| Eurogenerics NV
  Heizel Esplanade Heysel B 22
  B-1020 Brussel | Paroxetine EG 20 mg | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline SA/NV
  Rue du Tilleul 13
  B-1332 Genval | Aropax | 20 mg | Tablet | Oral use |
| GlaxoSmithKline SA/NV
  Rue du Tilleul 13
  B-1332 Genval | Aropax | 30 mg | Tablet | Oral use |
| GlaxoSmithKline SA/NV
  Rue du Tilleul 13
  B-1332 Genval | Aropax
  Suspension orale | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline SA/NV
  Rue du Tilleul 13
  B-1332 Genval | Seroxat | 20 mg | Tablet | Oral use |
| GlaxoSmithKline SA/NV
  Rue du Tilleul 13
  B-1332 Genval | Seroxat | 30 mg | Tablet | Oral use |
| GlaxoSmithKline SA/NV
  Rue du Tilleul 13
  B-1332 Genval | Seroxat Suspension orale | 2 mg/ml | Oral suspension | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Parocetan 20 mg | 20 mg | Film-coated tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Paroxetiphar 20 mg | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm Belgium SA/NV
  Rue Aaint-Lambert 141
  B-1200 Bruxelles | Paroxetine — Ratiopharm 20 mg | 20 mg | Film-coated tablet | Oral use |
| Merck SA/NV
  Brusselsesteenweg 288
  B-3090 Overijse | Merck — Paroxetine 20 mg | 20 mg | Film-coated tablet | Oral use |
| CYPRUS | Medochemie Ltd
  1-10 Constantinoupoleos str.
  PO Box 51407
  3505 Lemesos
  Cyprus | Arketis | 20 mg | Film-coated tablet | Oral use |
| Medochemie Ltd
  1-10 Constantinoupoleos str.
  PO Box 51407
  3505 Lemesos
  Cyprus | Arketis | 30 mg | Film-coated tablet | Oral use |
| C.A. Papaellinas & Co. Ltd
  161 Old Lefkosia-Lemesos Road
  PO Box 24018
  1700 Lefkosia
  Cyprus | Seroxat | 20 mg | Tablet | Oral use |
| C.A. Papaellinas & Co. Ltd
  161 Old Lefkosia-Lemesos Road
  PO Box 24018
  1700 Lefkosia
  Cyprus | Seroxat | 30 mg | Tablet | Oral use |
| CZECH REPUBLIC | Apotex Europe Ltd
  Rowan House 41 London Street
  Reading
  Berkshire RG1 4PS
  United Kingdom | Apo-Parox | 20 mg | Film-coated tablet | Oral use |
| Hexal A/S
  Kanalholmen 8-12
  DK-2650 Hvidovre | Parolex 20 | 20 mg, | Film-coated tablet | Oral use |
| Hexal A/S
  Kanalholmen 8-12
  DK-2650 Hvidovre | Parolex 40 | 40 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-890 79 Ulm | Paroxetin-Ratiopharm 20 mg | 20 mg | Film-coated tablet | Oral use |
| Chemical works of Gedeon Richter Ltd
  Gyömröi út 19-21
  H-1103 Budapest | Remood 20 mg | 20 mg | Film-coated tablet | Oral use |
| Chemical works of Gedeon Richter Ltd
  Gyömröi út 19-21
  H-1103 Budapest | Remood 30 mg | 30 mg | Film-coated tablet | Oral use |
| Smithkline Beecham Pharmaceuticals
  New Horizont Court,
  TW8 9EP Brentford,
  Middlesex
  United Kingdom | Seroxat 20 mg | 20 mg | Film-coated tablet | Oral use |
| Smithkline Beecham Pharmaceuticals
  New Horizont Court,
  TW8 9EP Brentford,
  Middlesex
  United Kingdom | Seroxat 30 mg | 30 mg | Film-coated tablet | Oral use |
| DENMARK | 1A Farma A/S
  Herstedøstervej 27-29
  DK-2620 Albertslund | Paroxetine ‘1A Farma’ | 20 mg | Film-coated tablet | Oral use |
| 1A Farma A/S
  Herstedøstervej 27-29
  DK-2620 Albertslund | Paroxetine ‘1A Farma’ | 40 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Oxetine | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetin ‘GEA’ | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetin ‘GEA’ | 40 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroc | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroc | 40 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroneurin | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroneurin | 40 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Optipar | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Optipar | 40 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Roxac | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Roxac | 40 mg | Film-coated tablet | Oral use |
| Alpharma AS
  Harbitzalléen 3
  N-Skøyen, 0212 Oslo | Paroxetin ‘Alpharma’ | 20 mg | Film-coated tablet | Oral use |
| Sandoz GmbH
  Biochemiestraße 10
  A-6250 Kundl | Paroxetin ‘Biochemie’ | 20 mg | Film-coated tablet | Oral use |
| Sandoz GmbH
  Biochemiestraße 10
  A-6250 Kundl | Paroxetin
  ‘Biochemie’ | 30 mg | Film-coated tablet | Oral use |
| DuraScan Medical Products A/S
  Svendborgvej 243
  DK-5260 Odense S | Serodur | 20 mg | Film-coated tablet | Oral use |
| Generics (UK) Limited
  Station Close
  Potters Bar
  Hertfordshire EN6 1TL
  United Kingdom | Paroxetin ‘Generics’ | 20 mg | Film-coated tablet | Oral use |
| Generics (UK) Limited
  Station Close
  Potters Bar
  Hertfordshire EN6 1TL
  United Kingdom | Pasero | 20 mg | Film-coated tablet | Oral use |
| Genthon BV
  Microweg 22
  6545 CM Nijmegen
  Nederland | Paroxetin
  ‘Genthon’ | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Pharma A/S
  Nykær 68
  DK-2605 Brøndby | Seroxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Pharma A/S
  Nykær 68
  DK-2605 Brøndby | Seroxat | 30 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Pharma A/S
  Nykær 68
  DK-2605 Brøndby | Seroxat | 2 mg/ml | Oral suspension | Oral use |
| NM Pharma A/S
  Lautrupvang 8
  DK-2750 Ballerup | Paroxetin ‘NM’ | 20 mg | Film-coated tablet | Oral use |
| NM Pharma A/S
  Lautrupvang 8
  DK-2750 Ballerup | Paroxetin ‘NM’ | 30 mg | Film-coated tablet | Oral use |
| PharmaCoDane Aps
  Marielundvej 46 A
  DK-2730 Herlev | Paroxetin ‘PCD’ | 20 mg | Film-coated tablet | Oral use |
| Copyfarm A/S
  Energivej 15
  DK-5260 Odense S | Paroxetin ‘Copyfarm’ | 20 mg | Film-coated tablet | Oral use |
| Copyfarm A/S
  Energivej 15
  DK-5260 Odense S | Paroxetine ‘Copyfarm’ | 30 mg | Film-coated tablet | Oral use |
| Pharmascope Ltd.
  Unit 107
  Ashbourne Industrial Estate
  Co. Meath
  Ireland | Meparox | 20 mg | Film-coated tablet | Oral use |
| Pharmascope Ltd.
  Unit 107
  Ashbourne Industrial Estate
  Co. Meath
  Ireland | Meparox | 30 mg | Film-coated tablet | Oral use |
| Pharmascope Ltd.
  Unit 107
  Ashbourne Industrial Estate
  Co. Meath
  Ireland | Paroscope | 20 mg | Film-coated tablet | Oral use |
| Pharmascope Ltd.
  Unit 107
  Ashbourne Industrial Estate
  Co. Meath
  Ireland | Paroscope | 30 mg | Film-coated tablet | Oral use |
| United Nordic Pharma A/S
  Hammervej 7
  DK-2970 Hørsholm | Paroxetin ‘UNP’ | 20 mg | Film-coated tablet | Oral use |
| United Nordic Pharma A/S
  Hammervej 7
  DK-2970 Hørsholm | Paroxetin ‘UNP’ | 30 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxegen | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxegen | 30 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxetin ‘Ratiopharm’ | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Sopax | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Pasorex | 20 mg | Film-coated tablet | Oral use |
| Scand Pharm Generics AB
  Ynglingagatan 14, 5tr
  S-11347 Stockholm | Serorex | 20 mg | Film-coated tablet | Oral use |
| Scand Pharm Generics AB
  Ynglingagatan 14, 5tr
  S-11347 Stockholm | Serorex | 30 mg | Film-coated tablet | Oral use |
| Scand Pharm Generics AB
  Ynglingagatan 14, 5tr
  S-11347 Stockholm | Seroxetabs | 20 mg | Film-coated tablet | Oral use |
| Synthon BV
  Microweg 22
  6545 CM Nijmegen
  Nederland | Euplix | 20 mg | Film-coated tablet | Oral use |
| Synthon BV
  Microweg 22
  6545 CM Nijmegen
  Nederland | Paroxetin ‘Synthon’ | 20 mg | Film-coated tablet | Oral use |
| Synthon BV
  Microweg 22
  6545 CM Nijmegen
  Nederland | Parsyn | 20 mg | Film-coated tablet | Oral use |
| Synthon BV
  Microweg 22
  6545 CM Nijmegen
  Nederland | Varoxetin | 20 mg | Film-coated tablet | Oral use |
| ESTONIA | Glaxo Group Ltd
  Berkeley Avenue,
  Greenford
  Middlesex TW8 9GS
  United Kingdom | Paroxat | 20 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestraße 25
  D-83607 Holzkirchen | Paroxetinhexal 20 | 20 mg | Tablet | Oral use |
| Hexal AG
  Industriestraße 25
  D-83607 Holzkirchen | Paroxetinhexal 40 | 40 mg | Tablet | Oral use |
| Richter
  Gyömröi ut 19-21
  H-1103 Budapest X | Rexetin | 20 mg | Tablet | Oral use |
| Richter
  Gyömröi ut 19-21
  H-1103 Budapest X | Rexetin 30 mg | 30 mg | Tablet | Oral use |
| SmithKline Beecham
  980 Great West Road, Brentford
  Middlesex TW8 9GS
  United Kingdom | Seroxat | 20 mg | Tablet | Oral use |
| SmithKline Beecham
  980 Great West Road, Brentford
  Middlesex TW8 9GS
  United Kingdom | Seroxat | 30 mg | Coated tablet | Oral use |
| FINLAND | A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Optipar | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Optipar | 40 mg | Film-coated tablet | Oral use |
| Genthon BV
  Microweg 22
  6545 CM
  Nijmegen
  Nederland | Euplix | 20 mg | Film-coated tablet | Oral use |
| Pharmcom Oy
  Keijumaki 6B 30
  FIN-02130 Espoo | Parox | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxetin ratiopharm | 20 mg | Film-coated tablet | Oral use |
| SmithKline Beecham Plc
  980 Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Seroxat | 20 mg | Film-coated tablet | Oral use |
| SmithKline Beecham Plc
  980 Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Seroxat | 2 mg/ml | Oral suspension | Oral use |
| STADA Arzneimittel AG
  Stadastraße 2-18
  D-61118 Bad Vilbel | Paroxetin Stada | 20 mg | Film-coated tablet | Oral use |
| FRANCE | Chiesi SA
  11 Avenue Dubonnet
  F-92400 Courbevoie | Divarius | 20 mg | Coated tablet | Oral use |
| Laboratoires G GAM
  Europarc
  33 rue Auguste Perret
  F-94042 Creteil Cedex | Paroxetine G GAM | 20 mg | Coated tablet | Oral use |
| Laboratoires G GAM
  Europarc
  33 rue Auguste Perret
  F-94042 Creteil Cedex | Paroxetine G GAM | 40 mg | Coated tablet | Oral use |
| Laboratoire GlaxoSmithKline
  100 route de Versailles
  F-78163 Marly-le-Roy | Deroxat | 20 mg | Coated tablet | Oral use |
| Laboratoire GlaxoSmithKline
  100 route de Versailles
  F-78163 Marly-le-Roy | Deroxat | 20 mg/10 ml | Oral suspension | Oral use |
| Laboratoire GlaxoSmithKline
  100 route de Versailles
  F-78163 Marly-le-Roy | Paroxetine GSK | 20 mg | Coated tablet | Oral use |
| Laboratoire GlaxoSmithKline
  100 route de Versailles
  F-78163 Marly-le-Roy | Paroxetine GSK | 20 mg/10 ml | Oral suspension | Oral use |
| Laboratoire Paucourt
  100 route de Versailles
  F-78163 Marly-le-Roy | Paroxetine Paucourt | 20 mg/10 ml | Oral suspension | Oral use |
| KIRON Pharmaceutica BV
  Groesbeekseweg 11
  6524 CK Nijmegen, Nederland | Paroxetine Kiron | 20 mg | Coated tablet | Oral use |
| Merck Generiques
  34 rue Saint Romain
  F-69359 Lyon Cedex 08 | Paroxetine Merck | 20 mg | Coated tablet | Oral use |
| Qualimed
  34 rue Saint Romain
  F-69359 Lyon Cedex 08 | Paroxetine Qualimed | 20 mg | Coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxetine Ratiopharm | 20 mg | Coated tablet | Oral use |
| Laboratoire Saint-Germain
  100 route de Versailles
  F-78163 Marly-le Roy | Paroxetine Saint Germain | 20 mg/10 ml | Oral suspension | Oral use |
| GERMANY | 1 A Pharma GmbH
  Keltenring 1+3
  D-82041 Oberhaching | Paroxetin — 1A Pharma40 mg Filmtabletten | 40 mg | Film-coated tablet | Oral use |
| 1 A Pharma GmbH
  Keltenring 1+3
  D-82041 Oberhaching | Paroxetin — 1 A Pharma 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| AbZ-Pharma GmbH
  Dr. Georg-Spohn-Str. 7
  D-89143 Blaubeuren | Paroxetin AbZ 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| STADA Arzneimittel AG
  Stadastraße 2 — 18
  D-61118 Bad Vilbel | Paroxetin AL 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Aliud Pharma GmbH & Co.KG
  Gottlieb-Daimler-Str. 19
  D-89150 Laichingen | Paroxetin Aliud 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Alpharma-ISIS GmbH & Co.KG
  Elisabeth-Selbert-Str. 1
  D-40764 Langenfeld | Paroxetin-Isis 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| AWD.Pharma GmbH & Co.KG
  Leipziger Str. 7-13
  D-01097 Dresden | Oxet 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Azupharma GmbH & Co.
  Dieselstr. 5
  D-70839 Gerlingen | Paroxetin AZU 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Betapharm Arzneimittel GmbH
  Kobelweg 95
  D-86156 Augsburg | Paroxetin beta 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Betapharm Arzneimittel GmbH
  Kobelweg 95
  D-86156 Augsburg | Paroxetin beta 40 mg Filmtabletten | 40 mg | Film-coated tablet | Oral use |
| Ct-Arzneimittel GmbH
  Lengeder Str. 42a
  D-13407 Berlin | Paroxetin von ct 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Falken-Apotheke
  Dr. Klaus Hultzsch, Kirchhohl 14
  D-65207 Wiesbaden | Depar | 20 mg | Film-coated tablet | Oral use |
| Falken-Apotheke
  Dr. Klaus Hultzsch, Kirchhohl 14
  D-65207 Wiesbaden | Genpar | 20 mg | Film-coated tablet | Oral use |
| Falken-Apotheke
  Dr. Klaus Hultzsch, Kirchhohl 14
  D-65207 Wiesbaden | Osepar | 20 mg | Film-coated tablet | Oral use |
| Esparma GmbH
  Lange Göhren 3
  D-39171 Osterweddingen | Aroxetin | 20 mg | Film-coated tablet | Oral use |
| Biomo pharma GmbH
  Lendersberstr. 86
  D-53721 Siegburg | Paroxetin-biomo 20 mg | 20 mg | Film-coated tablet | Oral use |
| Falken-Apotheke
  Dr. Klaus Hultzsch, Kirchhohl 14
  D-65207 Wiesbaden | Trapar | 20 mg | Film-coated tablet | Oral use |
| Falken-Apotheke
  Dr. Klaus Hultzsch, Kirchhohl 14
  D-65207 Wiesbaden | Zwapar | 20 mg | Film-coated tablet | Oral use |
| Generics (UK) Limited
  Station Close
  Potters Bar
  Hertfordshire EN6 1TL
  United Kingdom | Pasero 20 mg, Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline GmbH & Co.KG
  Theresienhöhe 11
  D-80339 München | Seroxat Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline GmbH & Co.KG
  Theresienhöhe 11
  D-80339 München | Seroxat Suspension | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline GmbH & Co.KG
  Theresienhöhe 11
  D-80339 München | Tagonis Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline GmbH & Co.KG
  Theresienhöhe 11
  D-80339 München | Tagonis Suspension | 2 mg/ml | Oral suspension | Oral use |
| Heumann Pharma GmbH
  Südwestpark 50
  D-90449 Nürnberg | Paroxetin, Heumann 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestr. 25
  D-83607 Holzkirchen | Paroc 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestr. 25
  D-83607 Holzkirchen | Paroc 40 mg Filmtabletten | 40 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestr. 25
  D-83607 Holzkirchen | Paroxat 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestr. 25
  D-83607 Holzkirchen | Paroxat 40 mg Filmtabletten | 40 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestr. 25
  D-83607 Holzkirchen | Roxac 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestr. 25
  D-83607 Holzkirchen | Roxac 40 mg | 40 mg | Film-coated tablet | Oral use |
| Lichtenstein Pharmazeutica GmbH & Co
  Industrstr. 26
  D-56218 Mulheim-Karlich | ParoLich 20 Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Lindopharm GmbH
  Neustr. 82
  D-40721 Hilden | Paroxetin Lindo 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Lindopharm GmbH
  Neustr. 82
  D-40721 Hilden | Paroxetin Lindo 40 mg Filmtabletten | 40 mg | Film-coated tablet | Oral use |
| Merck dura GmbH
  Frankfurter Str. 133
  D-64293 Darmstadt | Paroxedura 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Merck dura GmbH
  Frankfurter Str. 133
  D-64293 Darmstadt | Paroxedura 30 mg | 30 mg | Film-coated tablet | Oral use |
| Neuraxpharm Arzneimittel GmbH & Co KG
  Elisabeth-Selbert-Str. 23
  D-40764 Langenfeld | Paroxetin-neuraxpharm 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxetin-ratiopharm 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxetin-ratiopharm 30 mg Filmtabletten | 30 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline GmbH & Co.KG
  Theresienhöhe 11
  D-80339 München | Oxepar Suspension | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline GmbH & Co.KG
  Theresienhöhe 11
  D-80339 München | Paxil Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline GmbH & Co.KG
  Theresienhöhe 11
  D-80339 München | Paxil Suspension | 2 mg/ml | Oral suspension | Oral use |
| Stadapharm GmbH
  Stadastr. 2-18
  D-61118 Bad Vilbel | Paroxetin STADA 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| Synthon B.V.
  Microweg 22
  6545 CM Nijmegen
  Nederland | Euplix 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| TAD Pharma GmbH
  Heinz-Lohmann-Str. 5
  D-27472 Cuxhaven | Paroxetin TAD 20 mg Filmtabletten | 20 mg | Film-coated tablet | Oral use |
| GREECE | GlaxoSmithKline A.E.B.E.
  266 Kifissias Avenue
  GR-15232 Chalandri, Athens | Seroxat | 20 mg | Tablet | Oral use |
| GlaxoSmithKline A.E.B.E.
  266 Kifissias Avenue
  GR-15232 Chalandri, Athens | Seroxat | 30 mg | Tablet | Oral use |
| GlaxoSmithKline A.E.B.E.
  266 Kifissias Avenue
  GR-15232 Chalandri, Athens | Seroxat | 10 mg/5 ml | Oral suspension | Oral use |
| HUNGARY | Apotex Europe Ltd.
  Rowan House
  41 London Street
  RG 14 Berkshire
  United Kingdom | Apodepi filmtabletta | 20 mg | Film-coated tablet | Oral use |
| Hexal Hungária Kft.
  Tímár u.20.
  H-1034 Bp | Paretin 20 mg filmtabletta | 20 mg | Film-coated tablet | Oral use |
| Hexal Hungária Kft.
  Tímár u.20.
  H-1034 Bp | Paretin 40 mg filmtabletta | 40 mg | Film-coated tablet | Oral use |
| IIP-Institut für industrielle Pharmazie F&E GmbH
  Benzstraße 2a
  D-63741 Aschaffenburg | Parhun filmtabletta | 20 mg | Film-coated tablet | Oral use |
| Generics UK Ltd.
  Potters Bar
  EN6 1AG Hertfordshire
  United Kingdom | Parogen 20 mg filmabletta | 20 mg | Film-coated tablet | Oral use |
| Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony | Paroxat 20 mg filmtabletta | 20 mg | Film-coated tablet | Oral use |
| Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony | Paroxat 30 mg filmtabletta | 30 mg | Film-coated tablet | Oral use |
| Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony | Paroxat szirup | 2 mg/ml | Syrup | Oral use |
| Ratiopharm Hungary Kft.
  Uzsoki u. 36/A
  H-1145 Bp | Paroxetin ratiopharm 20 mg filmtabletta | 20 mg | Film-coated tablet | Oral use |
| Richter Gedeon Rt.
  Gyömrői út 19-21.
  H-1103 Bp | Rextine 20 mg filmtabletta | 20 mg | Film-coated tablet | Oral use |
| Richter Gedeon Rt.
  Gyömrői út 19-21.
  H-1103 Bp | Rexetine 30 mg filmtabletta | 30 mg | Film-coated tablet | Oral use |
| Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony | Seroxat 20 mg tabletta | 20 mg | Tablet | Oral use |
| IRELAND | Rowex Limited
  Newtown, Bantry, Co. Cork, Ireland | Paroxetine Tablets 20 mg | 20 mg | Tablet | Oral use |
| Rowex Limited
  Newtown, Bantry, Co. Cork
  Ireland | Paroxetine Tablets 40 mg | 40 mg | Tablet | Oral use |
| Genthon BV
  Microweg 22
  6545 CM, Nijmegen
  Nederland | Meloxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline (Ireland) Ltd
  Stonemasons Way, Rathfarnham
  Dublin 16
  Ireland | Paroxetine 2 mg/ml | 2 mg/ml | Oral solution | Oral use |
| GlaxoSmithKline (Ireland) Ltd
  Stonemasons Way, Rathfarnham
  Dublin 16
  Ireland | Paroxetine Tablets 30 mg | 30 mg | Tablet | Oral use |
| Norton Healthcare Limited, IVAXQuays, Albert Basin, Royal Docks
  London E16 2QJ
  United Kingdom | Paroxetine Tablets 20 mg | 20 mg | Tablet | Oral use |
| Norton Healthcare Limited
  IVAX Quays
  Albert Basin, Royal Docks
  London E16 2QJ
  United Kingdom | Paroxetine Tablets 30 mg | 30 mg | Tablet | Oral use |
| Rowex Limited
  Newtown
  Bantry, Co. Cork
  Ireland | Parox Tablets 20 mg | 20 mg | Tablet | Oral use |
| GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
  Stonemasons Way
  Rathfarnham
  Dublin 16
  Ireland | Seroxat Tablets 20 mg | 20 mg | Tablet | Oral use |
| GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
  Stonemasons Way
  Rathfarnham
  Dublin 16
  Ireland | Seroxat Tablets 30 mg | 30 mg | Tablet | Oral use |
| GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
  Stonemasons Way
  Rathfarnham
  Dublin 16
  Ireland | Seroxat Oral
  Suspension | 20 mg/10 ml | Oral suspension | Oral use |
| ICELAND | Gerard Laboratories
  35/36 Baldoyle
  Industrial Estate
  Grange Road, Dublin 13
  Ireland | Paroxetin NM Pharma | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline ehf
  Thverholt 14
  P.O.Box 5499
  125 Reykjavik
  Iceland | Seroxat | 20 mg | Tablet | Oral use |
| GlaxoSmithKline ehf
  Thverholt 14
  P.O.Box 5499
  125 Reykjavik
  Iceland | Seroxat | 2 mg/ml | Mixture | Oral use |
| Omega Farma ehf
  Skútuvogi 1H
  104 Reykjavik
  Iceland | Paroxat | 10 mg | Tablet | Oral use |
| Omega Farma ehf
  Skútuvogi 1H
  104 Reykjavik
  Iceland | Paroxat | 20 mg | Tablet | Oral use |
| Omega Farma ehf
  Skútuvogi 1H
  104 Reykjavik
  Iceland | Paroxat | 30 mg | Tablet | Oral use |
| Synthon BV
  Microweg 22
  6545 CM
  Nijmegen
  Nederland | Euplix | 20 mg | Tablet | Oral use |
| ITALY | EG S.p.A.
  Via Pavia, 6
  I-20136 Milano | Paroxetina EG | 20 mg | Tablet | Oral use |
| Abbot S.p.A.
  Via Pontina KM 52,
  I-04010 Campo Verde (Aprilia), Latina | Sereupin | 20 mg | Tablet | Oral use |
| Abbot S.p.A.
  Via Pontina KM 52,
  I-04010 Campo Verde (Aprilia), Latina | Sereupin | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline S.p.A.
  Via Fleming 2
  I-37135 Verona | Seroxat | 20 mg | Tablet | Oral use |
| GlaxoSmithKline S.p.A.
  Via Fleming 2
  I-37135 Verona | Seroxat | 2 mg/ml | Oral suspension | Oral use |
| Merck Generics Italia Spa
  Via Aquileia 35
  Cinisello Balsamo | Paroxetina Merck Generics | 20 mg | Film-coated tablet | Oral use |
| Synthon BV,
  Microweg 22,
  6545 CM Nijmegen Nederland | Daparox | 20 mg | Tablet | Oral use |
| Valda Laboratori Farmaceutici S.p.A.
  Via Zambeletti
  I-20021 Baranzate Di Bollate, Milano | Eutimil | 20 mg | Tablet | Oral use |
| Valda Laboratori Farmaceutici S.p.A.
  Via Zambeletti
  I-20021 Baranzate Di Bollate, Milano | Eutimil | 2 mg/ml | Oral suspension | Oral use |
| LATVIA | Medochemie Ltd
  P.O. Box 51409
  CY-3505 Limassol
  Cyprus | Arketis | 20 mg | Tablet | Oral use |
| Glaxo Group Limited
  Greenford
  Middlesex
  UB6 0NN
  United Kingdom | Paroxat | 10 mg | Coated tablet | Oral use |
| Glaxo Group Limited
  Greenford
  Middlesex
  UB6 0NN
  United Kingdom | Paroxat | 20 mg | Coated tablet | Oral use |
| Glaxo Group Limited
  Greenford
  Middlesex
  UB6 0NN
  United Kingdom | Paroxat | 30 mg | Coated tablet | Oral use |
| Glaxo Group Limited
  Greenford
  Middlesex
  UB6 0NN
  United Kingdom | Seroxat | 10 mg | Coated tablet | Oral use |
| Glaxo Group Limited
  Greenford
  Middlesex
  UB6 0NN
  United Kingdom | Seroxat | 20 mg | Coated tablet | Oral use |
| Glaxo Group Limited
  Greenford
  Middlesex
  UB6 0NN
  United Kingdom | Seroxat | 30 mg | Coated tablet | Oral use |
| Gedeon Richter Ltd
  Gyomroi 19-21
  H-1103 Budapest | Rexetin | 20 mg | Film-coated tablet | Oral use |
| Gedeon Richter Ltd
  Gyomroi 19-21
  H-1103 Budapest | Rexetin | 30 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestraße 25
  Holzkirchen
  D-83607 | ParoxetinHexal | 20 mg | Coated tablet | Oral use |
| Hexal AG
  Industriestraße 25
  Holzkirchen
  D-83607 | ParoxetinHexal | 40 mg | Coated tablet | Oral use |
| LITHUANIA | Hexal AG
  Industriestraße 25
  D-83607 Holzkirchen | ParoxetinHexal | 20 mg | Film-coated tablet | Oral use |
| Hexal AG
  Industriestraße 25
  D-83607 Holzkirchen | ParoxetinHexal | 40 mg | Film-coated tablet | Oral use |
| Gedeon Richter Ltd.
  Gyomroi ut 19-24
  H-1103 Budapest | Rexetin | 20 mg | Film-coated tablet | Oral use |
| Gedeon Richter Ltd.
  Gyomroi ut 19-24
  H-1103 Budapest | Rexetin | 30 mg | Film-coated tablet | Oral use |
| SmithKline Beecham plc
  SB House, Great West road, Brentford, Middlesex
  United Kingdom | Seroxat | 20 mg | Film-coated tablet | Oral use |
| SmithKline Beecham plc
  SB House, Great West road, Brentford, Middlesex
  United Kingdom | Seroxat | 30 mg | Film-coated tablet | Oral use |
| LUXEMBOURG | GlaxoSmithKline S.A/N.V.
  Rue du Tilleul, 13
  B-1332 Genval | Aropax | 20 mg | Tablet | Oral use |
| GlaxoSmithKline S.A/N.V.
  Rue du Tilleul, 13
  B-1332 Genval | Aropax | 30 mg | Tablet | Oral use |
| GlaxoSmithKline S.A/N.V.
  Rue du Tilleul, 13
  B-1332 Genval | Aropax | 20 mg/10 ml | Oral suspension | Oral use |
| GlaxoSmithKline S.A/N.V.
  Rue du Tilleul, 13
  B-1332 Genval | Seroxat | 20 mg | Tablet | Oral use |
| GlaxoSmithKline S.A/N.V.
  Rue du Tilleul, 13
  B-1332 Genval | Seroxat | 30 mg | Tablet | Oral use |
| GlaxoSmithKline S.A/N.V.
  Rue du Tilleul, 13
  B-1332 Genval | Seroxat | 20 mg/10 ml | Oral suspension | Oral use |
| Merck S.A.
  288 Brusselsesteenweg
  B-3090 Overijse | Merck-Paroxetine
  20 mg | 20 mg | Tablet | Oral use |
| MALTA | Smithkline Beecham Plc
  SB House Great West Road Bentford TW8 9BD
  Middlesex United Kingdom | Seroxat | 20 mg | Coated tablet | Oral use |
| Actavis hf
  Reykjavikurvegur 78
  220
  Hafnarfjordur | Paxetin | 20 mg | Tablet | Oral use |
| THE NETHERLANDS | Centrafarm Services B.V
  Nieuwe Donk 9
  P.O.Box 289
  4870 AG Etten-Leur
  Nederland | Paroxetine CF 20 mg | 20 mg | Tablet | Oral use |
| Genthon BV
  Box 7071
  GN Nijmegen
  Nederland | Paroxetine 20 mg | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline BV
  Huister Heideweg 62
  P.O.Box 780
  3700 AT Zeist
  Nederland | Seroxat Suspensie 2 mg/ml | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline BV
  Huister Heideweg 62
  P.O.Box 780,
  3700 AT Zeist
  Nederland | Seroxat 20 mg tablets | 20 mg | Tablet | Oral use |
| GlaxoSmithKline BV
  Huister Heideweg 62
  P.O.Box 780
  3700 AT Zeist
  Nederland | Seroxat 30 mg tablets | 30 mg | Film-coated tablet | Oral use |
| Hexal Pharma Nederland B.V
  Pastoorslaan 28
  P.O.Box 251
  2182 BX Hillegom Nederland | Paroxetine 20 mg | 20 mg | Film-coated tablet | Oral use |
| Hexal Pharma Nederland B.V
  Pastoorslaan 28
  P.O.Box 251
  2182 BX Hillegom Nederland | Paroxetine 40 mg | 40 mg | Film-coated tablet | Oral use |
| I.C.C. BV
  P.O.Box 75
  6920 AB Duiven
  Nederland | Paroxetine
  20 mg | 20 mg | Tablet | Oral use |
| Merck Generics BV
  Dieselweg 25
  3752 LB Bunschoten
  Nederland | Paroxetine
  Merck 20 mg | 20 mg | Tablet | Oral use |
| Multipharma BV
  Gemeenschapspolderweg 28
  P.O.Box 216
  1382 GR Weesp
  Nederland | MP-Paroxetine
  20 mg | 20 mg | Film-coated tablet | Oral use |
| NORWAY | A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetine Gea | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetine Gea | 40 mg | Film-coated tablet | Oral use |
| Sandoz GmbH
  Biochemiestrasse 10
  A-6250 Kundl | Paroxetin Biochemie | 20 mg | Film-coated tablet | Oral use |
| Duranor AS
  Oslo | Serodur | 20 mg | Tablet | Oral use |
| GlaxoSmithKline AS
  Forskningsveien 2a
  Postbox 180 Vinderen
  N-0319, Oslo | Seroxat | 20 mg | Tablet | Oral use |
| NM Pharma AS
  Lilleakerveien, 2B, Oslo | Paroxetin NM Pharma | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Acro-Straße 3
  D-89079 Ulm | Paroxetin Ratiopharm | 20 mg | Film-coated tablet | Oral use |
| STADA Arzneimittel AG
  Stadastraße 2 — 18
  D-61118 Bad Vilbel | Paroxetin Stada | 20 mg | Film-coated tablet | Oral use |
| POLAND | Apotex Inc
  ul. Homera 46
  PL-04-624 Warsaw | Apo-Parox 20 | 20 mg | Film-coated tablet | Oral use |
| Pliva Kraków Zakłady Farmaceutyczne S.A
  ul. Mogilska 80
  PL-31-456 Cracow | Deprozel 20 mg | 20 mg | Film-coated tablet | Oral use |
| ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paxeratio | 20 mg | Film-coated tablet | Oral use |
| Gedeon Richter Ltd
  H-1103 Budapest, Gyömroi ut 19-21 | Rexetin | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Export Ltd
  980 Great West Road
  Brentford, Middlesex
  TW8 9GS
  United Kingdom | Seroxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline Export Ltd
  980 Great West Road
  Brentford, Middlesex
  TW89GS
  United Kingdom | Seroxat | 30 mg | Film-coated tablet | Oral use |
| Hexal Polska Sp. z o.o. ul Domaniewska 50C
  PL-02-672 Warsaw | Paxtin 20 | 20 mg | Film-coated tablet | Oral use |
| Hexal Polska Sp. z o.o. ul Domaniewska 50C
  PL-02-672 Warsaw | Paxtin 40 | 40 mg | Film-coated tablet | Oral use |
| PORTUGAL | Jaba Farmacêutica, SA
  Edifício Jaba — Rua da Tapada
  Grande, 2 — Zona Industrial da Abrunheira
  P-2710-089 Sintra | Denerval | 20 mg | Film-coated tablet | Oral use |
| Alpharma ApS
  Rua Virgílio Correia, 11-A
  P-1600-219 Lisboa | Paroxetina Alpharma 20 mg Comprimidos | 20 mg | Film-coated tablet | Oral use |
| Biara — Produtos Farmacêuticos, Lda.
  Rua Ramalho Ortigão, 45-A
  P-070-228 Lisboa | Paroxetina Biara 20 mg Comprimidos Revestidos | 20 mg | Film-coated tablet | Oral use |
| Sandoz GmbH
  Biochemiestraße 10
  A-6250 Kundl | Paroxetina Sandoz 20 mg Comprimidos | 20 mg | Film-coated tablet | Oral use |
| Farma APS — Produtos Farmacêuticos, SA
  Rua José Galhardo no. 3, loja 3 -C/v
  P-1750-131 Lisboa | Paroxetina APS 20 mg Comprimidos Revestidos | 20 mg | Film-coated tablet | Oral use |
| Bexal Produtos Farmacêuticos SA
  Rua Prof. Ricardo Jorge, 5 A
  Miraflores
  P-1495-153 Algés | Paroxetina Bexal 20 mg Comprimido revestido por película | 20 mg | Film-coated tablet | Oral use |
| Generis Farmacêutica, SA
  Rua José Galhardo no. 3
  P-1750-131 Lisboa | Paroxetina Generis 20 mg Comprimidos Revestidos | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithkline Produtos
  Farmacêuticos, Lda.
  Rua Dr. António Loureiro Borges, 3, Arquiparque
  Miraflores
  P-1495-131 Algés | Seroxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithkline Produtos Farmacêuticos, Lda.
  Rua Dr. António Loureiro Borges, 3, Arquiparque
  Miraflores
  P-1495-131 Algés | Seroxat | 2 mg/ml | Oral suspension | Oral use |
| Instituto Luso-Fármaco, Lda.
  Rua Dr. António Loureiro Borges, 3, Arquiparque
  Miraflores
  P-1495-131 Algés | Calmus | 20 mg | Film-coated tablet | Oral use |
| Laboratórios Azevedos — Indústria Farmacêutica, S.A.
  Estrada Nacional 117-2
  P-2724-503 Alfragide | Oxepar | 20 mg | Film-coated tablet | Oral use |
| Instituto Luso-Fármaco, Lda.
  Rua Dr. António Loureiro Borges, 3, Arquiparque
  Miraflores
  P-1495-131 Algés | Oxepar | 2 mg/ml | Oral suspension | Oral use |
| Medibial — Produtos Médicos e Farmacêuticos, SA
  Av. Da Siderurgia Nacional,
  P-4745-457 S. Mamede do Coronado | Paxetil | 20 mg | Film-coated tablet | Oral use |
| Medibial — Produtos Médicos e Farmacêuticos, SA
  Av. Da Siderurgia Nacional
  P-4745-457 S. Mamede do Coronado | Paxetil | 2 mg/ml | Oral suspension | Oral use |
| Merck Genéricos — Produtos Farmacêuticos, Lda.
  Rua Alfredo da Silva, 3 — C
  P-1300-040 Lisboa | Paroxetina
  Merck Genericos
  20 mg
  Comprimidos
  Revestidos | 20 mg | Film-coated tablet | Oral use |
| Merck SA
  Rua Alfredo da Silva, 3-C
  P-1300-040 Lisboa | Paxpar | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
  Edifício Tejo - 6o Piso - Rua Quinta do Pinheiro
  P-2790-143 Carnaxide | Paroxetina
  Ratiopharm
  20 mg
  Comprimidos | 20 mg | Film-coated tablet | Oral use |
| Synthon B.V.
  Microweg 22,
  6545 CM Nijmegen
  Nederland | Parox | 20 mg | Film-coated tablet | Oral use |
| Tecnimede — Sociedade Técnico - Medicinal, SA
  Rua Prof. Henrique de Barros
  Edifício Sagres, 3oA
  P-2685-338 Prior Velho | Paroxetina
  Tecnimede 20 mg Comprimidos Revestidos | 20 mg | Film-coated tablet | Oral use |
| SLOVAC REPUBLIC | Generics UK Ltd.
  Station Close, Potters Bar
  Herts EN6 1TL
  United Kingdom | Paretin 20mg | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskaes Vej 89
  DK-2000 Fraderiksberg | Parolex 20 | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskaes Vej 89
  DK-2000 Fraderiksberg | Parolex 40 | 40 mg | Film-coated tablet | Oral use |
| ratiopharm GmbH
  Gras-Orco-Straße 3
  D-89079 Ulm | Paroxetini-ratiopharm 20 mg | 20 mg | Film-coated tablet | Oral use |
| Gedeon Richter Ltd.
  Gyomroi út 19-21
  H-1103 Budapest | Remood 20 mg | 20 mg | Film-coated tablet | Oral use |
| Gedeon Richter Ltd.
  Gyomroi út 19-21
  H-1103 Budapest | Remood 30 mg | 30 mg | Film-coated tablet | Oral use |
| SmithKlineBeecham Pharmaceuticals
  980 Great West Road
  Brentford
  Middlesex
  TW8 9GS
  United Kingdom | Seroxat 20 mg tbl flm | 20 mg | Film-coated tablet | Oral use |
| SmithKlineBeecham Pharmaceuticals
  980 Great West Road
  Brentford
  Middlesex
  TW8 9GS
  United Kingdom | Seroxat 30 mg tbl flm | 30 mg | Film-coated tablet | Oral use |
| SLOVENIA | GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana | Paroxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana | Paroxat | 30 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana | Seroxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana | Seroxat | 30 mg | Film-coated tablet | Oral use |
| Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, Ljubljana | Parogen | 20 mg | Film-coated tablet | Oral use |
| SWEDEN | A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetine GEA | 20 mg | Film-coated tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetine GEA | 40 mg | Film-coated tablet | Oral use |
| Alpharma AS
  P.O. Box 158, Skoyen
  N-0212 Oslo | Paroxetin
  Alpharma | 20 mg | Film-coated tablet | Oral use |
| AWD. Pharma GmbH & Co. KG
  Leipziger Str. 7-13
  D-01097 Dresden | Paroximed | 20 mg | Film-coated tablet | Oral use |
| Gerard Laboratiories
  35/36 Baldoyle
  Industrial Estate
  Grange Road, Dublin 13
  Ireland | Paroxetin Scand
  Pharm | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline AB
  Box 263,
  SE-431 23 Mölndal | Seroxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline AB
  Box 263,
  SE-431 23 Mölndal | Seroxat | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline AB
  Box 263,
  SE-431 23 Mölndal | Paroxetin
  ratiopharm | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline AB
  Box 263,
  SE-431 23 Mölndal | Paroxat | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline AB
  Box 263,
  SE-431 23 Mölndal | Meradel | 20 mg | Tablet | Oral use |
| GlaxoSmithKline AB
  Box 263,
  SE-431 23 Mölndal | Eoxat | 20 mg | Tablet | Oral use |
| Heumann Pharma GmbH
  Südwestpark 50
  D-90449 Nürnberg | Deoxatine 20 mg
  Filmdragerade
  tabletter | 20 mg | Film-coated tablet | Oral use |
| Lichtenstein Pharmazeutica GmbH & Co.
  Industrstr. 26
  D-56218 Mulheim-Karlich | Mediparox | 20 mg | Film-coated tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Paroxetin
  ‘Medis’ | 20 mg | Film-coated tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Paroxetabs | 20 mg | Film-coated tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Parotamed | 20 mg | Film-coated tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Paraxodil | 20 mg | Film-coated tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Primoxatine | 20 mg | Film-coated tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Titroxatine | 20 mg | Film-coated tablet | Oral use |
| Neuraxpharm Arzneimittel GmbH & Co. KG
  Elisabeth-Selbert-Str. 23
  D-40764 Langenfeld | Isoxatine | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxin | 20 mg | Film-coated tablet | Oral use |
| STADA Arzneimittel AG
  Stadastraße 2 — 18
  D-61118 Bad Vilbel | Parocetan | 20 mg | Film-coated tablet | Oral use |
| STADA Arzneimittel AG
  Stadastraße 2 — 18
  D-61118 Bad Vilbel | Paroxiflex | 20 mg | Film-coated tablet | Oral use |
| STADA Arzneimittel AG
  Stadastraße 2 — 18
  D-61118 Bad Vilbel | Paroxistad | 20 mg | Film-coated tablet | Oral use |
| Synthon BV
  Microweg 22,
  6545 CM Nijmegen
  Nederland | Euplix | 20 mg | Film-coated tablet | Oral use |
| TAD Pharma GmbH
  Heinz-Lohmann-Straße 5
  D-27472 Cuxhaven | Medoxatine | 20 mg | Film-coated tablet | Oral use |
| SPAIN | A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetina Gea
  20 mg | 20 mg | Film-coated tablet | Oral Use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetina Gea
  40 mg | 40 mg | Film-coated tablet | Oral use |
| Bexal Farmaceutica S.A.
  Ventura Rodriguez 7, 5 planta
  E-28008 Madrid | Paroxetina Bexal
  20 mg
  comprimidos
  EFG | 20 mg | Film-coated tablet | Oral use |
| Laboratorios Davur S.L.
  Teide, 4-planta baja
  Poligono Empresarial La Marina
  E-28700 San Sebastian de los Reyes,
  Madrid | Paroxetina
  Davur 20 mg
  Comprimidos
  Recubiertos EFT | 20 mg | Coated tablet | Oral use |
| Faes Farma SA
  Maximo Aguirre 14
  E-48940 Lejona (Vizcaya) | Motivan 20 mg,
  comprimidos | 20 mg | Film-coated tablet | Oral use |
| Laboratorios Fournier SA
  Ronda de Poniente 16
  E-28760-Tres Cantos, Madrid | Casbol 20 mg comprimidos con cubierta pelicular | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline SA
  Severo Ochoa 2
  E-28760 Tres Cantos, Madrid | Seroxat 20 mg comprimidos con cubierta pelicular | 20 mg | Film-coated tablet | Oral use |
| Laboratorios Alter SA
  Mateo Inurria 30
  E-28036 Madrid | Paroxetina Alter 20 mg comprimidos con cubierta pelicular | 20 mg | Film-coated tablet | Oral use |
| Laboratorios Belmac SA
  Teide, 4-planta baja
  Poligono Empresarial La Marina
  E-28700 San Sebastián de los Reyes,
  Madrid | Xetin 20 mg comprimidos recubiertos | 20 mg | Coated tablet | Oral use |
| Merck Genericos S.L.
  Ctra.n-152
  Km 19 — Poligono Merck
  E-08100 Mollet del Valles, Barcelona | Paroxetina Merck 20 mg Comprimidos recubiertos EFG | 20 mg | Coated tablet | Oral use |
| Mundogen Farma SA
  Severo Ochoa, 2
  Parque Tecnológico de Madrid, E-28760 Tres Cantos, Madrid | Paroxetina Mundogen 20 mg comprimidos con cubierta pelicular EFG | 20 mg | Film-coated tablet | Oral use |
| Novartis Farmaceutica SA
  Gran Via de les Corts Catalanes 764
  E-08013 Barcelona | Frosinor 20 mg
  Comprimidos con cubierta pelicular | 20 mg | Film-coated tablet | Oral use |
| Ratiopharm España SA
  Avda. De Burgos,
  16D — 5a planta
  E-28036 Madrid | Paroxetina ratiopharm
  20 mg
  comprimidos recubiertos EFT | 20 mg | Coated tablet | Oral use |
| Laboratorios Rimafar S.L.
  Pololigono Malpica Calle c, No 4
  E-50016 Zaragoza | Paroxetina
  Rimafar 20 mg
  comprimidos
  recubiertos EFT | 20 mg | Coated tablet | Oral use |
| Synthon BV
  Microweg 22
  6545 CM Nijmegen
  Nederland | Paroxetina
  Synthon | 20 mg | Film-coated tablet | Oral use |
| Tamarang SA
  Balmes, 84-4-2a
  E-08008 Barcelona | Paroxetina
  Tamarang | 20 mg | Coated tablet | Oral use |
| Tamarang SA
  Balmes, 84-4-2a
  E-08008 Barcelona | Paroxetina
  Apotex-Farma | 20 mg | Coated tablet | Oral use |
| UNITED KINGDOM | A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetine
  20 mg Tablet | 20 mg | Tablet | Oral use |
| A/S GEA Farmaceutisk Fabrik
  Holger Danskes Vej 89
  DK-2000 Frederiksberg | Paroxetine
  40 mg Tablet | 40 mg | Tablet | Oral use |
| Alpharma Ltd
  Whiddon Valley
  Barnstaple
  N.Devon EX32 8NS
  United Kingdom | Paroxetine
  20 mg Tablet | 20 mg | Tablet | Oral use |
| Alpharma Ltd
  Whiddon Valley
  Barnstaple
  N.Devon EX32 8NS
  United Kingdom | Paroxetine
  30 mg Tablet | 30 mg | Tablet | Oral use |
| Apotex Europe Limited
  Rowan House
  41 London street
  Reading; Berkshire
  RG1 4PS
  United Kingdom | Paroxetine
  20 mg Tablet | 20 mg | Tablet | Oral use |
| Generics (UK) Limited
  Station Close; Potters Bar
  Hertfordshire EN6 1TL
  United Kingdom | Paroxetine
  20 mg Film-coated tablet | 20 mg | Film-coated tablet | Oral use |
| GlaxoSmithKline UK Limited
  Stockley Park West
  Uxbridge
  Middlesex
  UB11 1BT
  United Kingdom | Seroxat Tablets 20 mg | 20 mg | Tablet | Oral use |
| GlaxoSmithKline UK Limited
  Stockley Park West
  Uxbridge
  Middlesex
  UB11 1BT
  United Kingdom | Seroxat Tablers 30 mg | 30 mg | Tablet | Oral use |
| GlaxoSmithKline UK Limited
  Stockley Park West
  Uxbridge
  Middlesex
  UB11 1BT
  United Kingdom | Seroxat Liquid 20 mg/10 ml | 2 mg/ml | Oral suspension | Oral use |
| GlaxoSmithKline UK Limited
  Stockley Park West
  Uxbridge
  Middlesex
  UB11 1BT
  United Kingdom | Paroxetine Hydrochloride Tablets 20 mg | 20 mg | Tablet | Oral use |
| GlaxoSmithKline UK Limited
  Stockley Park West
  Uxbridge
  Middlesex
  UB11 1BT
  United Kingdom | Paroxetine Hydrochloride Tablets 30 mg | 30 mg | Tablet | Oral use |
| GlaxoSmithKline UK Limited
  Stockley Park West
  Uxbridge
  Middlesex
  UB11 1BT
  United Kingdom | Paroxetine Hydrochloride Liquid 20 mg/10 ml | 2 mg/ml | Oral suspension | Oral use |
| Lagap Pharmaceuticals Ltd;
  Woolmer Way; Bordon;
  Hampshire GU35 9QE,
  United Kingdom | Paroxetine 20 mg Tablet | 20 mg | Tablet | Oral use |
| Medis-Danmark A/S
  Havelse Molle 14
  DK-3600 Frederikssund | Paroxetine 20 mg Tablet | 20 mg | Tablet | Oral use |
| Norton Healthcare Limited
  IVAX Quays, Albert Basin, Royal Docks
  London E16 2QJ
  United Kingdom | Paroxetine Hydrochloride Tablets 20 mg | 20 mg | Tablet | Oral use |
| Ratiopharm GmbH
  Graf-Arco-Straße 3
  D-89079 Ulm | Paroxetine 20 mg tablets | 20 mg | Tablet | Oral use |

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

AUSTRIA

Gerot Pharmazeutika GesmbH

Arnethgasse 3

A-1160 Wien

Allenopar 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Allen Pharmazeutika GesmbH

Albert Schweitzer Gasse 6

A-1140 Wien

Paroxetin ‘Allen’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Arcana Arzneimittel GmbH

Zimbagasse 5

A-1147 Wien

Paroxetin ‘Arcana’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl/Tirol

Paluxetil 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Pharma GmbH

Albert Schweitzer Gasse 6

A-1140 Wien

Seroxat 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Pharma GmbH

Albert Schweitzer Gasse 6

A-1140 Wien

Seroxat 2 mg/ml — oral suspension

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline Pharma GmbH

Albert Schweitzer Gasse 6

A-1140 Wien

Glaxopar 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Pharma GmbH

Albert Schweitzer Gasse 6

A-1140 Wien

Paroglax 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Pharma GmbH

Albert Schweitzer Gasse 6

A-1140 Wien

Paroxetin ‘GSK’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Hexal Pharma GmbH

Wilhelminestraße 91/IIf/3

A-1160 Wien

Paroxat 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Hexal Pharma GmbH

Wilhelminestraße 91/IIf/3

A-1160 Wien

Paroxat 40 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Interpharm Produktions GmbH

Effingergasse 21

A-1160 Wien

Paroxetin ‘Interpharm’ Filmtabletten

20 mg

Film-coated tablet

Oral use

Lannacher Heilmittel GmbH

Schlossplatz 1

A-8502 Lannach

Ennos 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Ratiopharm Arzneimittel Vertriebs — GmbH

Albert Schweitzer Gasse 3

A-1140 Wien

Paroxetin ‘Merckle’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Ratiopharm Arzneimittel Vertriebs — GmbH

Albert Schweitzer Gasse 3

A-1140 Wien

Paroxetin ‘ratiopharm’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Stada Arzneimittel GmbH

Heiligenstädter Str. 52

A-1190 Wien

Parocetan 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

BELGIUM

Bexal

Av J. Bordet 168

B-1140 Brussels

Paroxetine Bexal 20 mg

20 mg

Film-coated tablet

Oral use

Bexal

Av J. Bordet 168

B-1140 Brussels

Paroxetine Bexal 40 mg

40 mg

Film-coated tablet

Oral use

Eurogenerics NV

Heizel Esplanade Heysel B 22

B-1020 Brussel

Paroxetine EG 20 mg

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline SA/NV

Rue du Tilleul 13

B-1332 Genval

Aropax

20 mg

Tablet

Oral use

GlaxoSmithKline SA/NV

Rue du Tilleul 13

B-1332 Genval

Aropax

30 mg

Tablet

Oral use

GlaxoSmithKline SA/NV

Rue du Tilleul 13

B-1332 Genval

Aropax

Suspension orale

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline SA/NV

Rue du Tilleul 13

B-1332 Genval

Seroxat

20 mg

Tablet

Oral use

GlaxoSmithKline SA/NV

Rue du Tilleul 13

B-1332 Genval

Seroxat

30 mg

Tablet

Oral use

GlaxoSmithKline SA/NV

Rue du Tilleul 13

B-1332 Genval

Seroxat Suspension orale

2 mg/ml

Oral suspension

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Parocetan 20 mg

20 mg

Film-coated tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Paroxetiphar 20 mg

20 mg

Film-coated tablet

Oral use

Ratiopharm Belgium SA/NV

Rue Aaint-Lambert 141

B-1200 Bruxelles

Paroxetine — Ratiopharm 20 mg

20 mg

Film-coated tablet

Oral use

Merck SA/NV

Brusselsesteenweg 288

B-3090 Overijse

Merck — Paroxetine 20 mg

20 mg

Film-coated tablet

Oral use

CYPRUS

Medochemie Ltd

1-10 Constantinoupoleos str.

PO Box 51407

3505 Lemesos

Cyprus

Arketis

20 mg

Film-coated tablet

Oral use

Medochemie Ltd

1-10 Constantinoupoleos str.

PO Box 51407

3505 Lemesos

Cyprus

Arketis

30 mg

Film-coated tablet

Oral use

C.A. Papaellinas & Co. Ltd

161 Old Lefkosia-Lemesos Road

PO Box 24018

1700 Lefkosia

Cyprus

Seroxat

20 mg

Tablet

Oral use

C.A. Papaellinas & Co. Ltd

161 Old Lefkosia-Lemesos Road

PO Box 24018

1700 Lefkosia

Cyprus

Seroxat

30 mg

Tablet

Oral use

CZECH REPUBLIC

Apotex Europe Ltd

Rowan House 41 London Street

Reading

Berkshire RG1 4PS

United Kingdom

Apo-Parox

20 mg

Film-coated tablet

Oral use

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Parolex 20

20 mg,

Film-coated tablet

Oral use

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Parolex 40

40 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-890 79 Ulm

Paroxetin-Ratiopharm 20 mg

20 mg

Film-coated tablet

Oral use

Chemical works of Gedeon Richter Ltd

Gyömröi út 19-21

H-1103 Budapest

Remood 20 mg

20 mg

Film-coated tablet

Oral use

Chemical works of Gedeon Richter Ltd

Gyömröi út 19-21

H-1103 Budapest

Remood 30 mg

30 mg

Film-coated tablet

Oral use

Smithkline Beecham Pharmaceuticals

New Horizont Court,

TW8 9EP Brentford,

Middlesex

United Kingdom

Seroxat 20 mg

20 mg

Film-coated tablet

Oral use

Smithkline Beecham Pharmaceuticals

New Horizont Court,

TW8 9EP Brentford,

Middlesex

United Kingdom

Seroxat 30 mg

30 mg

Film-coated tablet

Oral use

DENMARK

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Paroxetine ‘1A Farma’

20 mg

Film-coated tablet

Oral use

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Paroxetine ‘1A Farma’

40 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Oxetine

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetin ‘GEA’

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetin ‘GEA’

40 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroc

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroc

40 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroneurin

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroneurin

40 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Optipar

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Optipar

40 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Roxac

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Roxac

40 mg

Film-coated tablet

Oral use

Alpharma AS

Harbitzalléen 3

N-Skøyen, 0212 Oslo

Paroxetin ‘Alpharma’

20 mg

Film-coated tablet

Oral use

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Paroxetin ‘Biochemie’

20 mg

Film-coated tablet

Oral use

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Paroxetin

‘Biochemie’

30 mg

Film-coated tablet

Oral use

DuraScan Medical Products A/S

Svendborgvej 243

DK-5260 Odense S

Serodur

20 mg

Film-coated tablet

Oral use

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Paroxetin ‘Generics’

20 mg

Film-coated tablet

Oral use

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Pasero

20 mg

Film-coated tablet

Oral use

Genthon BV

Microweg 22

6545 CM Nijmegen

Nederland

Paroxetin

‘Genthon’

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Pharma A/S

Nykær 68

DK-2605 Brøndby

Seroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Pharma A/S

Nykær 68

DK-2605 Brøndby

Seroxat

30 mg

Film-coated tablet

Oral use

GlaxoSmithKline Pharma A/S

Nykær 68

DK-2605 Brøndby

Seroxat

2 mg/ml

Oral suspension

Oral use

NM Pharma A/S

Lautrupvang 8

DK-2750 Ballerup

Paroxetin ‘NM’

20 mg

Film-coated tablet

Oral use

NM Pharma A/S

Lautrupvang 8

DK-2750 Ballerup

Paroxetin ‘NM’

30 mg

Film-coated tablet

Oral use

PharmaCoDane Aps

Marielundvej 46 A

DK-2730 Herlev

Paroxetin ‘PCD’

20 mg

Film-coated tablet

Oral use

Copyfarm A/S

Energivej 15

DK-5260 Odense S

Paroxetin ‘Copyfarm’

20 mg

Film-coated tablet

Oral use

Copyfarm A/S

Energivej 15

DK-5260 Odense S

Paroxetine ‘Copyfarm’

30 mg

Film-coated tablet

Oral use

Pharmascope Ltd.

Unit 107

Ashbourne Industrial Estate

Co. Meath

Ireland

Meparox

20 mg

Film-coated tablet

Oral use

Pharmascope Ltd.

Unit 107

Ashbourne Industrial Estate

Co. Meath

Ireland

Meparox

30 mg

Film-coated tablet

Oral use

Pharmascope Ltd.

Unit 107

Ashbourne Industrial Estate

Co. Meath

Ireland

Paroscope

20 mg

Film-coated tablet

Oral use

Pharmascope Ltd.

Unit 107

Ashbourne Industrial Estate

Co. Meath

Ireland

Paroscope

30 mg

Film-coated tablet

Oral use

United Nordic Pharma A/S

Hammervej 7

DK-2970 Hørsholm

Paroxetin ‘UNP’

20 mg

Film-coated tablet

Oral use

United Nordic Pharma A/S

Hammervej 7

DK-2970 Hørsholm

Paroxetin ‘UNP’

30 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxegen

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxegen

30 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxetin ‘Ratiopharm’

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Sopax

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Pasorex

20 mg

Film-coated tablet

Oral use

Scand Pharm Generics AB

Ynglingagatan 14, 5tr

S-11347 Stockholm

Serorex

20 mg

Film-coated tablet

Oral use

Scand Pharm Generics AB

Ynglingagatan 14, 5tr

S-11347 Stockholm

Serorex

30 mg

Film-coated tablet

Oral use

Scand Pharm Generics AB

Ynglingagatan 14, 5tr

S-11347 Stockholm

Seroxetabs

20 mg

Film-coated tablet

Oral use

Synthon BV

Microweg 22

6545 CM Nijmegen

Nederland

Euplix

20 mg

Film-coated tablet

Oral use

Synthon BV

Microweg 22

6545 CM Nijmegen

Nederland

Paroxetin ‘Synthon’

20 mg

Film-coated tablet

Oral use

Synthon BV

Microweg 22

6545 CM Nijmegen

Nederland

Parsyn

20 mg

Film-coated tablet

Oral use

Synthon BV

Microweg 22

6545 CM Nijmegen

Nederland

Varoxetin

20 mg

Film-coated tablet

Oral use

ESTONIA

Glaxo Group Ltd

Berkeley Avenue,

Greenford

Middlesex TW8 9GS

United Kingdom

Paroxat

20 mg

Film-coated tablet

Oral use

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Paroxetinhexal 20

20 mg

Tablet

Oral use

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Paroxetinhexal 40

40 mg

Tablet

Oral use

Richter

Gyömröi ut 19-21

H-1103 Budapest X

Rexetin

20 mg

Tablet

Oral use

Richter

Gyömröi ut 19-21

H-1103 Budapest X

Rexetin 30 mg

30 mg

Tablet

Oral use

SmithKline Beecham

980 Great West Road, Brentford

Middlesex TW8 9GS

United Kingdom

Seroxat

20 mg

Tablet

Oral use

SmithKline Beecham

980 Great West Road, Brentford

Middlesex TW8 9GS

United Kingdom

Seroxat

30 mg

Coated tablet

Oral use

FINLAND

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Optipar

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Optipar

40 mg

Film-coated tablet

Oral use

Genthon BV

Microweg 22

6545 CM

Nijmegen

Nederland

Euplix

20 mg

Film-coated tablet

Oral use

Pharmcom Oy

Keijumaki 6B 30

FIN-02130 Espoo

Parox

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxetin ratiopharm

20 mg

Film-coated tablet

Oral use

SmithKline Beecham Plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Seroxat

20 mg

Film-coated tablet

Oral use

SmithKline Beecham Plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Seroxat

2 mg/ml

Oral suspension

Oral use

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Paroxetin Stada

20 mg

Film-coated tablet

Oral use

FRANCE

Chiesi SA

11 Avenue Dubonnet

F-92400 Courbevoie

Divarius

20 mg

Coated tablet

Oral use

Laboratoires G GAM

Europarc

33 rue Auguste Perret

F-94042 Creteil Cedex

Paroxetine G GAM

20 mg

Coated tablet

Oral use

Laboratoires G GAM

Europarc

33 rue Auguste Perret

F-94042 Creteil Cedex

Paroxetine G GAM

40 mg

Coated tablet

Oral use

Laboratoire GlaxoSmithKline

100 route de Versailles

F-78163 Marly-le-Roy

Deroxat

20 mg

Coated tablet

Oral use

Laboratoire GlaxoSmithKline

100 route de Versailles

F-78163 Marly-le-Roy

Deroxat

20 mg/10 ml

Oral suspension

Oral use

Laboratoire GlaxoSmithKline

100 route de Versailles

F-78163 Marly-le-Roy

Paroxetine GSK

20 mg

Coated tablet

Oral use

Laboratoire GlaxoSmithKline

100 route de Versailles

F-78163 Marly-le-Roy

Paroxetine GSK

20 mg/10 ml

Oral suspension

Oral use

Laboratoire Paucourt

100 route de Versailles

F-78163 Marly-le-Roy

Paroxetine Paucourt

20 mg/10 ml

Oral suspension

Oral use

KIRON Pharmaceutica BV

Groesbeekseweg 11

6524 CK Nijmegen, Nederland

Paroxetine Kiron

20 mg

Coated tablet

Oral use

Merck Generiques

34 rue Saint Romain

F-69359 Lyon Cedex 08

Paroxetine Merck

20 mg

Coated tablet

Oral use

Qualimed

34 rue Saint Romain

F-69359 Lyon Cedex 08

Paroxetine Qualimed

20 mg

Coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxetine Ratiopharm

20 mg

Coated tablet

Oral use

Laboratoire Saint-Germain

100 route de Versailles

F-78163 Marly-le Roy

Paroxetine Saint Germain

20 mg/10 ml

Oral suspension

Oral use

GERMANY

1 A Pharma GmbH

Keltenring 1+3

D-82041 Oberhaching

Paroxetin — 1A Pharma40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

1 A Pharma GmbH

Keltenring 1+3

D-82041 Oberhaching

Paroxetin — 1 A Pharma 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Paroxetin AbZ 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

STADA Arzneimittel AG

Stadastraße 2 — 18

D-61118 Bad Vilbel

Paroxetin AL 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Aliud Pharma GmbH & Co.KG

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Paroxetin Aliud 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Alpharma-ISIS GmbH & Co.KG

Elisabeth-Selbert-Str. 1

D-40764 Langenfeld

Paroxetin-Isis 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

AWD.Pharma GmbH & Co.KG

Leipziger Str. 7-13

D-01097 Dresden

Oxet 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Azupharma GmbH & Co.

Dieselstr. 5

D-70839 Gerlingen

Paroxetin AZU 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Paroxetin beta 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Paroxetin beta 40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

Ct-Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Paroxetin von ct 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Falken-Apotheke

Dr. Klaus Hultzsch, Kirchhohl 14

D-65207 Wiesbaden

Depar

20 mg

Film-coated tablet

Oral use

Falken-Apotheke

Dr. Klaus Hultzsch, Kirchhohl 14

D-65207 Wiesbaden

Genpar

20 mg

Film-coated tablet

Oral use

Falken-Apotheke

Dr. Klaus Hultzsch, Kirchhohl 14

D-65207 Wiesbaden

Osepar

20 mg

Film-coated tablet

Oral use

Esparma GmbH

Lange Göhren 3

D-39171 Osterweddingen

Aroxetin

20 mg

Film-coated tablet

Oral use

Biomo pharma GmbH

Lendersberstr. 86

D-53721 Siegburg

Paroxetin-biomo 20 mg

20 mg

Film-coated tablet

Oral use

Falken-Apotheke

Dr. Klaus Hultzsch, Kirchhohl 14

D-65207 Wiesbaden

Trapar

20 mg

Film-coated tablet

Oral use

Falken-Apotheke

Dr. Klaus Hultzsch, Kirchhohl 14

D-65207 Wiesbaden

Zwapar

20 mg

Film-coated tablet

Oral use

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Pasero 20 mg, Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline GmbH & Co.KG

Theresienhöhe 11

D-80339 München

Seroxat Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline GmbH & Co.KG

Theresienhöhe 11

D-80339 München

Seroxat Suspension

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline GmbH & Co.KG

Theresienhöhe 11

D-80339 München

Tagonis Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline GmbH & Co.KG

Theresienhöhe 11

D-80339 München

Tagonis Suspension

2 mg/ml

Oral suspension

Oral use

Heumann Pharma GmbH

Südwestpark 50

D-90449 Nürnberg

Paroxetin, Heumann 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Paroc 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Paroc 40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Paroxat 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Paroxat 40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Roxac 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Roxac 40 mg

40 mg

Film-coated tablet

Oral use

Lichtenstein Pharmazeutica GmbH & Co

Industrstr. 26

D-56218 Mulheim-Karlich

ParoLich 20 Filmtabletten

20 mg

Film-coated tablet

Oral use

Lindopharm GmbH

Neustr. 82

D-40721 Hilden

Paroxetin Lindo 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Lindopharm GmbH

Neustr. 82

D-40721 Hilden

Paroxetin Lindo 40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

Merck dura GmbH

Frankfurter Str. 133

D-64293 Darmstadt

Paroxedura 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Merck dura GmbH

Frankfurter Str. 133

D-64293 Darmstadt

Paroxedura 30 mg

30 mg

Film-coated tablet

Oral use

Neuraxpharm Arzneimittel GmbH & Co KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Paroxetin-neuraxpharm 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxetin-ratiopharm 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxetin-ratiopharm 30 mg Filmtabletten

30 mg

Film-coated tablet

Oral use

GlaxoSmithKline GmbH & Co.KG

Theresienhöhe 11

D-80339 München

Oxepar Suspension

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline GmbH & Co.KG

Theresienhöhe 11

D-80339 München

Paxil Filmtabletten

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline GmbH & Co.KG

Theresienhöhe 11

D-80339 München

Paxil Suspension

2 mg/ml

Oral suspension

Oral use

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Paroxetin STADA 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Nederland

Euplix 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Paroxetin TAD 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

GREECE

GlaxoSmithKline A.E.B.E.

266 Kifissias Avenue

GR-15232 Chalandri, Athens

Seroxat

20 mg

Tablet

Oral use

GlaxoSmithKline A.E.B.E.

266 Kifissias Avenue

GR-15232 Chalandri, Athens

Seroxat

30 mg

Tablet

Oral use

GlaxoSmithKline A.E.B.E.

266 Kifissias Avenue

GR-15232 Chalandri, Athens

Seroxat

10 mg/5 ml

Oral suspension

Oral use

HUNGARY

Apotex Europe Ltd.

Rowan House

41 London Street

RG 14 Berkshire

United Kingdom

Apodepi filmtabletta

20 mg

Film-coated tablet

Oral use

Hexal Hungária Kft.

Tímár u.20.

H-1034 Bp

Paretin 20 mg filmtabletta

20 mg

Film-coated tablet

Oral use

Hexal Hungária Kft.

Tímár u.20.

H-1034 Bp

Paretin 40 mg filmtabletta

40 mg

Film-coated tablet

Oral use

IIP-Institut für industrielle Pharmazie F&E GmbH

Benzstraße 2a

D-63741 Aschaffenburg

Parhun filmtabletta

20 mg

Film-coated tablet

Oral use

Generics UK Ltd.

Potters Bar

EN6 1AG Hertfordshire

United Kingdom

Parogen 20 mg filmabletta

20 mg

Film-coated tablet

Oral use

Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony

Paroxat 20 mg filmtabletta

20 mg

Film-coated tablet

Oral use

Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony

Paroxat 30 mg filmtabletta

30 mg

Film-coated tablet

Oral use

Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony

Paroxat szirup

2 mg/ml

Syrup

Oral use

Ratiopharm Hungary Kft.

Uzsoki u. 36/A

H-1145 Bp

Paroxetin ratiopharm 20 mg filmtabletta

20 mg

Film-coated tablet

Oral use

Richter Gedeon Rt.

Gyömrői út 19-21.

H-1103 Bp

Rextine 20 mg filmtabletta

20 mg

Film-coated tablet

Oral use

Richter Gedeon Rt.

Gyömrői út 19-21.

H-1103 Bp

Rexetine 30 mg filmtabletta

30 mg

Film-coated tablet

Oral use

Glaxo Smith Kline Kft. 1124 Bp. Csörsz u. 43. MOM Park Gesztenyés torony

Seroxat 20 mg tabletta

20 mg

Tablet

Oral use

IRELAND

Rowex Limited

Newtown, Bantry, Co. Cork, Ireland

Paroxetine Tablets 20 mg

20 mg

Tablet

Oral use

Rowex Limited

Newtown, Bantry, Co. Cork

Ireland

Paroxetine Tablets 40 mg

40 mg

Tablet

Oral use

Genthon BV

Microweg 22

6545 CM, Nijmegen

Nederland

Meloxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way, Rathfarnham

Dublin 16

Ireland

Paroxetine 2 mg/ml

2 mg/ml

Oral solution

Oral use

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way, Rathfarnham

Dublin 16

Ireland

Paroxetine Tablets 30 mg

30 mg

Tablet

Oral use

Norton Healthcare Limited, IVAXQuays, Albert Basin, Royal Docks

London E16 2QJ

United Kingdom

Paroxetine Tablets 20 mg

20 mg

Tablet

Oral use

Norton Healthcare Limited

IVAX Quays

Albert Basin, Royal Docks

London E16 2QJ

United Kingdom

Paroxetine Tablets 30 mg

30 mg

Tablet

Oral use

Rowex Limited

Newtown

Bantry, Co. Cork

Ireland

Parox Tablets 20 mg

20 mg

Tablet

Oral use

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Seroxat Tablets 20 mg

20 mg

Tablet

Oral use

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Seroxat Tablets 30 mg

30 mg

Tablet

Oral use

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Seroxat Oral

Suspension

20 mg/10 ml

Oral suspension

Oral use

ICELAND

Gerard Laboratories

35/36 Baldoyle

Industrial Estate

Grange Road, Dublin 13

Ireland

Paroxetin NM Pharma

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline ehf

Thverholt 14

P.O.Box 5499

125 Reykjavik

Iceland

Seroxat

20 mg

Tablet

Oral use

GlaxoSmithKline ehf

Thverholt 14

P.O.Box 5499

125 Reykjavik

Iceland

Seroxat

2 mg/ml

Mixture

Oral use

Omega Farma ehf

Skútuvogi 1H

104 Reykjavik

Iceland

Paroxat

10 mg

Tablet

Oral use

Omega Farma ehf

Skútuvogi 1H

104 Reykjavik

Iceland

Paroxat

20 mg

Tablet

Oral use

Omega Farma ehf

Skútuvogi 1H

104 Reykjavik

Iceland

Paroxat

30 mg

Tablet

Oral use

Synthon BV

Microweg 22

6545 CM

Nijmegen

Nederland

Euplix

20 mg

Tablet

Oral use

ITALY

EG S.p.A.

Via Pavia, 6

I-20136 Milano

Paroxetina EG

20 mg

Tablet

Oral use

Abbot S.p.A.

Via Pontina KM 52,

I-04010 Campo Verde (Aprilia), Latina

Sereupin

20 mg

Tablet

Oral use

Abbot S.p.A.

Via Pontina KM 52,

I-04010 Campo Verde (Aprilia), Latina

Sereupin

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline S.p.A.

Via Fleming 2

I-37135 Verona

Seroxat

20 mg

Tablet

Oral use

GlaxoSmithKline S.p.A.

Via Fleming 2

I-37135 Verona

Seroxat

2 mg/ml

Oral suspension

Oral use

Merck Generics Italia Spa

Via Aquileia 35

Cinisello Balsamo

Paroxetina Merck Generics

20 mg

Film-coated tablet

Oral use

Synthon BV,

Microweg 22,

6545 CM Nijmegen Nederland

Daparox

20 mg

Tablet

Oral use

Valda Laboratori Farmaceutici S.p.A.

Via Zambeletti

I-20021 Baranzate Di Bollate, Milano

Eutimil

20 mg

Tablet

Oral use

Valda Laboratori Farmaceutici S.p.A.

Via Zambeletti

I-20021 Baranzate Di Bollate, Milano

Eutimil

2 mg/ml

Oral suspension

Oral use

LATVIA

Medochemie Ltd

P.O. Box 51409

CY-3505 Limassol

Cyprus

Arketis

20 mg

Tablet

Oral use

Glaxo Group Limited

Greenford

Middlesex

UB6 0NN

United Kingdom

Paroxat

10 mg

Coated tablet

Oral use

Glaxo Group Limited

Greenford

Middlesex

UB6 0NN

United Kingdom

Paroxat

20 mg

Coated tablet

Oral use

Glaxo Group Limited

Greenford

Middlesex

UB6 0NN

United Kingdom

Paroxat

30 mg

Coated tablet

Oral use

Glaxo Group Limited

Greenford

Middlesex

UB6 0NN

United Kingdom

Seroxat

10 mg

Coated tablet

Oral use

Glaxo Group Limited

Greenford

Middlesex

UB6 0NN

United Kingdom

Seroxat

20 mg

Coated tablet

Oral use

Glaxo Group Limited

Greenford

Middlesex

UB6 0NN

United Kingdom

Seroxat

30 mg

Coated tablet

Oral use

Gedeon Richter Ltd

Gyomroi 19-21

H-1103 Budapest

Rexetin

20 mg

Film-coated tablet

Oral use

Gedeon Richter Ltd

Gyomroi 19-21

H-1103 Budapest

Rexetin

30 mg

Film-coated tablet

Oral use

Hexal AG

Industriestraße 25

Holzkirchen

D-83607

ParoxetinHexal

20 mg

Coated tablet

Oral use

Hexal AG

Industriestraße 25

Holzkirchen

D-83607

ParoxetinHexal

40 mg

Coated tablet

Oral use

LITHUANIA

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

ParoxetinHexal

20 mg

Film-coated tablet

Oral use

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

ParoxetinHexal

40 mg

Film-coated tablet

Oral use

Gedeon Richter Ltd.

Gyomroi ut 19-24

H-1103 Budapest

Rexetin

20 mg

Film-coated tablet

Oral use

Gedeon Richter Ltd.

Gyomroi ut 19-24

H-1103 Budapest

Rexetin

30 mg

Film-coated tablet

Oral use

SmithKline Beecham plc

SB House, Great West road, Brentford, Middlesex

United Kingdom

Seroxat

20 mg

Film-coated tablet

Oral use

SmithKline Beecham plc

SB House, Great West road, Brentford, Middlesex

United Kingdom

Seroxat

30 mg

Film-coated tablet

Oral use

LUXEMBOURG

GlaxoSmithKline S.A/N.V.

Rue du Tilleul, 13

B-1332 Genval

Aropax

20 mg

Tablet

Oral use

GlaxoSmithKline S.A/N.V.

Rue du Tilleul, 13

B-1332 Genval

Aropax

30 mg

Tablet

Oral use

GlaxoSmithKline S.A/N.V.

Rue du Tilleul, 13

B-1332 Genval

Aropax

20 mg/10 ml

Oral suspension

Oral use

GlaxoSmithKline S.A/N.V.

Rue du Tilleul, 13

B-1332 Genval

Seroxat

20 mg

Tablet

Oral use

GlaxoSmithKline S.A/N.V.

Rue du Tilleul, 13

B-1332 Genval

Seroxat

30 mg

Tablet

Oral use

GlaxoSmithKline S.A/N.V.

Rue du Tilleul, 13

B-1332 Genval

Seroxat

20 mg/10 ml

Oral suspension

Oral use

Merck S.A.

288 Brusselsesteenweg

B-3090 Overijse

Merck-Paroxetine

20 mg

20 mg

Tablet

Oral use

MALTA

Smithkline Beecham Plc

SB House Great West Road Bentford TW8 9BD

Middlesex United Kingdom

Seroxat

20 mg

Coated tablet

Oral use

Actavis hf

Reykjavikurvegur 78

220

Hafnarfjordur

Paxetin

20 mg

Tablet

Oral use

THE NETHERLANDS

Centrafarm Services B.V

Nieuwe Donk 9

P.O.Box 289

4870 AG Etten-Leur

Nederland

Paroxetine CF 20 mg

20 mg

Tablet

Oral use

Genthon BV

Box 7071

GN Nijmegen

Nederland

Paroxetine 20 mg

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline BV

Huister Heideweg 62

P.O.Box 780

3700 AT Zeist

Nederland

Seroxat Suspensie 2 mg/ml

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline BV

Huister Heideweg 62

P.O.Box 780,

3700 AT Zeist

Nederland

Seroxat 20 mg tablets

20 mg

Tablet

Oral use

GlaxoSmithKline BV

Huister Heideweg 62

P.O.Box 780

3700 AT Zeist

Nederland

Seroxat 30 mg tablets

30 mg

Film-coated tablet

Oral use

Hexal Pharma Nederland B.V

Pastoorslaan 28

P.O.Box 251

2182 BX Hillegom Nederland

Paroxetine 20 mg

20 mg

Film-coated tablet

Oral use

Hexal Pharma Nederland B.V

Pastoorslaan 28

P.O.Box 251

2182 BX Hillegom Nederland

Paroxetine 40 mg

40 mg

Film-coated tablet

Oral use

I.C.C. BV

P.O.Box 75

6920 AB Duiven

Nederland

Paroxetine

20 mg

20 mg

Tablet

Oral use

Merck Generics BV

Dieselweg 25

3752 LB Bunschoten

Nederland

Paroxetine

Merck 20 mg

20 mg

Tablet

Oral use

Multipharma BV

Gemeenschapspolderweg 28

P.O.Box 216

1382 GR Weesp

Nederland

MP-Paroxetine

20 mg

20 mg

Film-coated tablet

Oral use

NORWAY

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetine Gea

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetine Gea

40 mg

Film-coated tablet

Oral use

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Paroxetin Biochemie

20 mg

Film-coated tablet

Oral use

Duranor AS

Oslo

Serodur

20 mg

Tablet

Oral use

GlaxoSmithKline AS

Forskningsveien 2a

Postbox 180 Vinderen

N-0319, Oslo

Seroxat

20 mg

Tablet

Oral use

NM Pharma AS

Lilleakerveien, 2B, Oslo

Paroxetin NM Pharma

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Acro-Straße 3

D-89079 Ulm

Paroxetin Ratiopharm

20 mg

Film-coated tablet

Oral use

STADA Arzneimittel AG

Stadastraße 2 — 18

D-61118 Bad Vilbel

Paroxetin Stada

20 mg

Film-coated tablet

Oral use

POLAND

Apotex Inc

ul. Homera 46

PL-04-624 Warsaw

Apo-Parox 20

20 mg

Film-coated tablet

Oral use

Pliva Kraków Zakłady Farmaceutyczne S.A

ul. Mogilska 80

PL-31-456 Cracow

Deprozel 20 mg

20 mg

Film-coated tablet

Oral use

ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paxeratio

20 mg

Film-coated tablet

Oral use

Gedeon Richter Ltd

H-1103 Budapest, Gyömroi ut 19-21

Rexetin

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex

TW8 9GS

United Kingdom

Seroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex

TW89GS

United Kingdom

Seroxat

30 mg

Film-coated tablet

Oral use

Hexal Polska Sp. z o.o. ul Domaniewska 50C

PL-02-672 Warsaw

Paxtin 20

20 mg

Film-coated tablet

Oral use

Hexal Polska Sp. z o.o. ul Domaniewska 50C

PL-02-672 Warsaw

Paxtin 40

40 mg

Film-coated tablet

Oral use

PORTUGAL

Jaba Farmacêutica, SA

Edifício Jaba — Rua da Tapada

Grande, 2 — Zona Industrial da Abrunheira

P-2710-089 Sintra

Denerval

20 mg

Film-coated tablet

Oral use

Alpharma ApS

Rua Virgílio Correia, 11-A

P-1600-219 Lisboa

Paroxetina Alpharma 20 mg Comprimidos

20 mg

Film-coated tablet

Oral use

Biara — Produtos Farmacêuticos, Lda.

Rua Ramalho Ortigão, 45-A

P-070-228 Lisboa

Paroxetina Biara 20 mg Comprimidos Revestidos

20 mg

Film-coated tablet

Oral use

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Paroxetina Sandoz 20 mg Comprimidos

20 mg

Film-coated tablet

Oral use

Farma APS — Produtos Farmacêuticos, SA

Rua José Galhardo no. 3, loja 3 -C/v

P-1750-131 Lisboa

Paroxetina APS 20 mg Comprimidos Revestidos

20 mg

Film-coated tablet

Oral use

Bexal Produtos Farmacêuticos SA

Rua Prof. Ricardo Jorge, 5 A

Miraflores

P-1495-153 Algés

Paroxetina Bexal 20 mg Comprimido revestido por película

20 mg

Film-coated tablet

Oral use

Generis Farmacêutica, SA

Rua José Galhardo no. 3

P-1750-131 Lisboa

Paroxetina Generis 20 mg Comprimidos Revestidos

20 mg

Film-coated tablet

Oral use

GlaxoSmithkline Produtos

Farmacêuticos, Lda.

Rua Dr. António Loureiro Borges, 3, Arquiparque

Miraflores

P-1495-131 Algés

Seroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithkline Produtos Farmacêuticos, Lda.

Rua Dr. António Loureiro Borges, 3, Arquiparque

Miraflores

P-1495-131 Algés

Seroxat

2 mg/ml

Oral suspension

Oral use

Instituto Luso-Fármaco, Lda.

Rua Dr. António Loureiro Borges, 3, Arquiparque

Miraflores

P-1495-131 Algés

Calmus

20 mg

Film-coated tablet

Oral use

Laboratórios Azevedos — Indústria Farmacêutica, S.A.

Estrada Nacional 117-2

P-2724-503 Alfragide

Oxepar

20 mg

Film-coated tablet

Oral use

Instituto Luso-Fármaco, Lda.

Rua Dr. António Loureiro Borges, 3, Arquiparque

Miraflores

P-1495-131 Algés

Oxepar

2 mg/ml

Oral suspension

Oral use

Medibial — Produtos Médicos e Farmacêuticos, SA

Av. Da Siderurgia Nacional,

P-4745-457 S. Mamede do Coronado

Paxetil

20 mg

Film-coated tablet

Oral use

Medibial — Produtos Médicos e Farmacêuticos, SA

Av. Da Siderurgia Nacional

P-4745-457 S. Mamede do Coronado

Paxetil

2 mg/ml

Oral suspension

Oral use

Merck Genéricos — Produtos Farmacêuticos, Lda.

Rua Alfredo da Silva, 3 — C

P-1300-040 Lisboa

Paroxetina

Merck Genericos

20 mg

Comprimidos

Revestidos

20 mg

Film-coated tablet

Oral use

Merck SA

Rua Alfredo da Silva, 3-C

P-1300-040 Lisboa

Paxpar

20 mg

Film-coated tablet

Oral use

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Edifício Tejo - 6o Piso - Rua Quinta do Pinheiro

P-2790-143 Carnaxide

Paroxetina

Ratiopharm

20 mg

Comprimidos

20 mg

Film-coated tablet

Oral use

Synthon B.V.

Microweg 22,

6545 CM Nijmegen

Nederland

Parox

20 mg

Film-coated tablet

Oral use

Tecnimede — Sociedade Técnico - Medicinal, SA

Rua Prof. Henrique de Barros

Edifício Sagres, 3oA

P-2685-338 Prior Velho

Paroxetina

Tecnimede 20 mg Comprimidos Revestidos

20 mg

Film-coated tablet

Oral use

SLOVAC REPUBLIC

Generics UK Ltd.

Station Close, Potters Bar

Herts EN6 1TL

United Kingdom

Paretin 20mg

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskaes Vej 89

DK-2000 Fraderiksberg

Parolex 20

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskaes Vej 89

DK-2000 Fraderiksberg

Parolex 40

40 mg

Film-coated tablet

Oral use

ratiopharm GmbH

Gras-Orco-Straße 3

D-89079 Ulm

Paroxetini-ratiopharm 20 mg

20 mg

Film-coated tablet

Oral use

Gedeon Richter Ltd.

Gyomroi út 19-21

H-1103 Budapest

Remood 20 mg

20 mg

Film-coated tablet

Oral use

Gedeon Richter Ltd.

Gyomroi út 19-21

H-1103 Budapest

Remood 30 mg

30 mg

Film-coated tablet

Oral use

SmithKlineBeecham Pharmaceuticals

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Seroxat 20 mg tbl flm

20 mg

Film-coated tablet

Oral use

SmithKlineBeecham Pharmaceuticals

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Seroxat 30 mg tbl flm

30 mg

Film-coated tablet

Oral use

SLOVENIA

GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana

Paroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana

Paroxat

30 mg

Film-coated tablet

Oral use

GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana

Seroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana

Seroxat

30 mg

Film-coated tablet

Oral use

Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, Ljubljana

Parogen

20 mg

Film-coated tablet

Oral use

SWEDEN

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetine GEA

20 mg

Film-coated tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetine GEA

40 mg

Film-coated tablet

Oral use

Alpharma AS

P.O. Box 158, Skoyen

N-0212 Oslo

Paroxetin

Alpharma

20 mg

Film-coated tablet

Oral use

AWD. Pharma GmbH & Co. KG

Leipziger Str. 7-13

D-01097 Dresden

Paroximed

20 mg

Film-coated tablet

Oral use

Gerard Laboratiories

35/36 Baldoyle

Industrial Estate

Grange Road, Dublin 13

Ireland

Paroxetin Scand

Pharm

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline AB

Box 263,

SE-431 23 Mölndal

Seroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline AB

Box 263,

SE-431 23 Mölndal

Seroxat

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline AB

Box 263,

SE-431 23 Mölndal

Paroxetin

ratiopharm

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline AB

Box 263,

SE-431 23 Mölndal

Paroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline AB

Box 263,

SE-431 23 Mölndal

Meradel

20 mg

Tablet

Oral use

GlaxoSmithKline AB

Box 263,

SE-431 23 Mölndal

Eoxat

20 mg

Tablet

Oral use

Heumann Pharma GmbH

Südwestpark 50

D-90449 Nürnberg

Deoxatine 20 mg

Filmdragerade

tabletter

20 mg

Film-coated tablet

Oral use

Lichtenstein Pharmazeutica GmbH & Co.

Industrstr. 26

D-56218 Mulheim-Karlich

Mediparox

20 mg

Film-coated tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Paroxetin

‘Medis’

20 mg

Film-coated tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Paroxetabs

20 mg

Film-coated tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Parotamed

20 mg

Film-coated tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Paraxodil

20 mg

Film-coated tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Primoxatine

20 mg

Film-coated tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Titroxatine

20 mg

Film-coated tablet

Oral use

Neuraxpharm Arzneimittel GmbH & Co. KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Isoxatine

20 mg

Film-coated tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxin

20 mg

Film-coated tablet

Oral use

STADA Arzneimittel AG

Stadastraße 2 — 18

D-61118 Bad Vilbel

Parocetan

20 mg

Film-coated tablet

Oral use

STADA Arzneimittel AG

Stadastraße 2 — 18

D-61118 Bad Vilbel

Paroxiflex

20 mg

Film-coated tablet

Oral use

STADA Arzneimittel AG

Stadastraße 2 — 18

D-61118 Bad Vilbel

Paroxistad

20 mg

Film-coated tablet

Oral use

Synthon BV

Microweg 22,

6545 CM Nijmegen

Nederland

Euplix

20 mg

Film-coated tablet

Oral use

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

D-27472 Cuxhaven

Medoxatine

20 mg

Film-coated tablet

Oral use

SPAIN

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetina Gea

20 mg

20 mg

Film-coated tablet

Oral Use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetina Gea

40 mg

40 mg

Film-coated tablet

Oral use

Bexal Farmaceutica S.A.

Ventura Rodriguez 7, 5 planta

E-28008 Madrid

Paroxetina Bexal

20 mg

comprimidos

EFG

20 mg

Film-coated tablet

Oral use

Laboratorios Davur S.L.

Teide, 4-planta baja

Poligono Empresarial La Marina

E-28700 San Sebastian de los Reyes,

Madrid

Paroxetina

Davur 20 mg

Comprimidos

Recubiertos EFT

20 mg

Coated tablet

Oral use

Faes Farma SA

Maximo Aguirre 14

E-48940 Lejona (Vizcaya)

Motivan 20 mg,

comprimidos

20 mg

Film-coated tablet

Oral use

Laboratorios Fournier SA

Ronda de Poniente 16

E-28760-Tres Cantos, Madrid

Casbol 20 mg comprimidos con cubierta pelicular

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline SA

Severo Ochoa 2

E-28760 Tres Cantos, Madrid

Seroxat 20 mg comprimidos con cubierta pelicular

20 mg

Film-coated tablet

Oral use

Laboratorios Alter SA

Mateo Inurria 30

E-28036 Madrid

Paroxetina Alter 20 mg comprimidos con cubierta pelicular

20 mg

Film-coated tablet

Oral use

Laboratorios Belmac SA

Teide, 4-planta baja

Poligono Empresarial La Marina

E-28700 San Sebastián de los Reyes,

Madrid

Xetin 20 mg comprimidos recubiertos

20 mg

Coated tablet

Oral use

Merck Genericos S.L.

Ctra.n-152

Km 19 — Poligono Merck

E-08100 Mollet del Valles, Barcelona

Paroxetina Merck 20 mg Comprimidos recubiertos EFG

20 mg

Coated tablet

Oral use

Mundogen Farma SA

Severo Ochoa, 2

Parque Tecnológico de Madrid, E-28760 Tres Cantos, Madrid

Paroxetina Mundogen 20 mg comprimidos con cubierta pelicular EFG

20 mg

Film-coated tablet

Oral use

Novartis Farmaceutica SA

Gran Via de les Corts Catalanes 764

E-08013 Barcelona

Frosinor 20 mg

Comprimidos con cubierta pelicular

20 mg

Film-coated tablet

Oral use

Ratiopharm España SA

Avda. De Burgos,

16D — 5a planta

E-28036 Madrid

Paroxetina ratiopharm

20 mg

comprimidos recubiertos EFT

20 mg

Coated tablet

Oral use

Laboratorios Rimafar S.L.

Pololigono Malpica Calle c, No 4

E-50016 Zaragoza

Paroxetina

Rimafar 20 mg

comprimidos

recubiertos EFT

20 mg

Coated tablet

Oral use

Synthon BV

Microweg 22

6545 CM Nijmegen

Nederland

Paroxetina

Synthon

20 mg

Film-coated tablet

Oral use

Tamarang SA

Balmes, 84-4-2a

E-08008 Barcelona

Paroxetina

Tamarang

20 mg

Coated tablet

Oral use

Tamarang SA

Balmes, 84-4-2a

E-08008 Barcelona

Paroxetina

Apotex-Farma

20 mg

Coated tablet

Oral use

UNITED KINGDOM

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetine

20 mg Tablet

20 mg

Tablet

Oral use

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Frederiksberg

Paroxetine

40 mg Tablet

40 mg

Tablet

Oral use

Alpharma Ltd

Whiddon Valley

Barnstaple

N.Devon EX32 8NS

United Kingdom

Paroxetine

20 mg Tablet

20 mg

Tablet

Oral use

Alpharma Ltd

Whiddon Valley

Barnstaple

N.Devon EX32 8NS

United Kingdom

Paroxetine

30 mg Tablet

30 mg

Tablet

Oral use

Apotex Europe Limited

Rowan House

41 London street

Reading; Berkshire

RG1 4PS

United Kingdom

Paroxetine

20 mg Tablet

20 mg

Tablet

Oral use

Generics (UK) Limited

Station Close; Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Paroxetine

20 mg Film-coated tablet

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline UK Limited

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Seroxat Tablets 20 mg

20 mg

Tablet

Oral use

GlaxoSmithKline UK Limited

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Seroxat Tablers 30 mg

30 mg

Tablet

Oral use

GlaxoSmithKline UK Limited

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Seroxat Liquid 20 mg/10 ml

2 mg/ml

Oral suspension

Oral use

GlaxoSmithKline UK Limited

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Paroxetine Hydrochloride Tablets 20 mg

20 mg

Tablet

Oral use

GlaxoSmithKline UK Limited

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Paroxetine Hydrochloride Tablets 30 mg

30 mg

Tablet

Oral use

GlaxoSmithKline UK Limited

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Paroxetine Hydrochloride Liquid 20 mg/10 ml

2 mg/ml

Oral suspension

Oral use

Lagap Pharmaceuticals Ltd;

Woolmer Way; Bordon;

Hampshire GU35 9QE,

United Kingdom

Paroxetine 20 mg Tablet

20 mg

Tablet

Oral use

Medis-Danmark A/S

Havelse Molle 14

DK-3600 Frederikssund

Paroxetine 20 mg Tablet

20 mg

Tablet

Oral use

Norton Healthcare Limited

IVAX Quays, Albert Basin, Royal Docks

London E16 2QJ

United Kingdom

Paroxetine Hydrochloride Tablets 20 mg

20 mg

Tablet

Oral use

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Paroxetine 20 mg tablets

20 mg

Tablet

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES, ICELAND AND NORWAY

| Member State | Marketing authorisation holder | Product trade name | Strength | Pharma-ceutical form | Animal species | Frequency | Recommended dose | Withdrawal period
  (meat and milk) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AUSTRIA | Pfizer Corp. Austria
  Seidengasse 33-35
  A-1071 Wien | Dectomax 1 % Injektions-lösung für Rinder und Schafe | 10 mg/ml | Solution for injection | Cattle and sheep
  No treatment of animals producing milk for human consumption | Single dose | 200 μg/kg bw | Meat:
  Cattle: 42 days
  Sheep: 40 days |
| BELGIUM | Pfizer Animal Health S.A.
  Rue Laid Burniat 1
  B-1348 Louvain-la-Neuve | Dectomax | 10 mg/ml | Solution for injection | Cattle and sheep | Single dose | 200 μg/kg bw | Meat:
  Cattle: 42 days
  Sheep: 35 days
  Milk:
  Cattle: 60 days
  Sheep: 70 days |
| DENMARK | Pfizer Aps
  Lautrupvang 8
  DK 2750 Ballerup | Dectomax Vet
  DK MT NO 15721 | 10 mg/ml | Solution for injection | Cattle
  Not to be used in cattle producing milk for human consumption. | Single dose | 200 μg/kg bw | Meat:
  45 days
  Milk:
  Not to be used later than 60 days prior to expected calving. |
| FINLAND | Pfizer Oy, Animal Health
  Tietokuja 4
  FI-00330 Helsinki | Dectomax Vet | 10 mg/ml | Solution for injection | Cattle, Reindeer, Pigs
  Not permitted for use in animals producing milk for human consumption during lactation | Single dose | Cattle and reindeer:
  200 μg/kg bw
  Swine:
  300 μg/kg bw | Meat:
  Cattle and reindeer: 42 days
  Swine: 49 days
  Milk:
  Withdrawal period for milk 60 days for heifers, reindeer and animals during the dry period |
| FRANCE | Pfizer
  23/25 Ave du docteur Lannelongue
  F-75014 Paris | Dectomax | 10 mg/ml | Solution for injection | Cattle and sheep
  Not for use in dairy cows during lactating or drying off and not for use in dairy ewes | Single dose | Cattle:
  200 μg/kg bw (sc only)
  Sheep:
  200 μg/kg bw (sc or im) | Meat:
  Cattle: 42 days
  Sheep: 35 days (im), 56 days (sc) |
| GERMANY | Pfizer GmbH
  Pfizerstraße 1
  D-76139 Karlsruhe | Dectomax | 10 mg/ml | Solution for injection | Cattle and sheep
  Not permitted for use in lactating animals producing milk for human consumption | Single dose | 200 μg/kg bw | Meat:
  Cattle, sheep: 60 days |
| GREECE | Pfizer Hellas
  Alketou 5
  GR-11633 Pagrati — Athina | Dectomax | 10 mg/ml | Solution for injection | Sheep
  Cattle
  Not for use in dairy cows
  Pigs | Single dose | Sheep:
  200 μg/kg bw (sc, im)
  Cattle:
  200 μg/kg bw (sc)
  Pigs:
  300 μg/kg bw (im) | Meat:
  Sheep: 35 days
  Cattle: 42 days
  Pigs: 49 days
  Milk:
  Sheep: Do not use in dairy sheep, including pregnant ewes within 50 days of lambing
  Cattle: Do not use in non lactating dairy cows including pregnant dairy heifers within 60 days of calving |
| IRELAND | Pfizer Ltd.
  Walton Oaks,
  Dorking Road
  Tadworth, Surrey KT20 7NT United Kingdom | Dectomax 1 %
  Injectable solution | 10 mg/ml | Solution for injection | Cattle and sheep | Single dose | Cattle: 200 μg/kg bw
  Sheep: 300 μg/kg bw | Meat
  Cattle: 63 days
  Sheep: 63 days |
| ITALY | Pfizer Italia SRL
  Via Valbondione 113
  I-00188 Roma | Dectomax 1 %
  (doramectin) | 10 mg/ml | Solution for injection | Cattle, sheep and pigs
  Use not permitted in animals producing milk for human use | Single dose | Cattle and sheep:
  200 μg/kg bw
  Pigs:
  300 μg/kg bw | Meat:
  Cattle: 42 days
  Sheep: 35 days
  Pigs: 37 days |
| LUXEMBOURG | Pfizer Animal Health
  Rue Laid Burniat 1
  B-1348 Louvain-la-Neuve | Dectomax | 10 mg/ml | Injection | Cattle and sheep
  Not for use in cattle producing milk for human consumption.
  Not for use in sheep producing milk for human consumption | Single dose | Cattle:
  200 μg/kg bw (sc)
  Sheep:
  300 μg/kg bw (sc or im) | Meat:
  Cattle: 42 days
  Sheep: 35 days
  Milk:
  Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving.
  Sheep: Not for use in the last 70 days before lambing |
| THE NETHERLANDS | Pfizer Animal Health BV
  PO Box 37
  2900 AA Capelle aan den IJssel
  Nederland | Dectomax (REG NL 9844)
  Prontax (REG NL 9884) | 10 mg/ml | Solution for injection | Non-lactating cattle and sheep,
  pigs | Single dose. Sheep; repeated if signs of P.ovis infection do not disappear in 14 days | Cattle and sheep: 200 μg/kg bw Pigs: 300 μg/kg bw | Meat:
  Cattle: 75 days
  Sheep: 70 days
  Pigs: 77 days
  Milk:
  Cattle and sheep: product not allowed for milking sheep. |
| PORTUGAL | Laboratórios Pfizer, Lda
  Lagoas Park
  Edifício 10
  P-2740-244 Porte Salvo | Dectomax solution injectable | 10 mg/ml | Solution for injection | Cattle, sheep and pigs | Single dose | Cattle and sheep:
  200 μg/kg bw
  Pigs:
  300 μg/kg bw | Meat:
  Cattle: 42 days
  Sheep: 35 days
  Pigs: 56 days
  Milk:
  Cattle: Forbidden in lactating cows, not to be administered 60 days before calving
  Sheep: Forbidden in lactating sheep, not to be administered 70 days before lambing |
| SPAIN | Pfizer
  Av da. De Europa, 20b
  Parque Empresarial La Moraleja
  E-28108 Alcobendas | Dectomax solution injectable | 10 mg/ml | Solution for injection | Cattle and sheep | Single dose | 200 μg/kg bw | Meat
  Cattle: 42 days
  Sheep: 60 days |
| SWEDEN | Pfizer AB
  Box 501
  S-183 25 Täby | Dectomax vet | 10 mg/ml | Solution for injection | Cattle, sheep, (reindeer) | Not specified in the SPC | Catt1e (and reindeer):
  200 μg/kg bw (sc)
  Sheep:
  200 μg/kg bw (sc or im) | Meat:
  Cattle: 49 days
  Sheep: 45 days (im); 60 days (sc)
  Reindeer: 42 days
  Milk:
  Cattle: forbidden in lactating cows, not to be administered less than 60 days before calving
  Sheep: forbidden in lactating sheep, not to be administered less than 70 days before lambing |
| UNITED KINGDOM | Pfizer Ltd
  Pfizer Ltd, Sandwich, Kent CT13 9NJ,
  United Kingdom | Dectomax Injectable Solution for Cattle and Sheep | 10mg/ml | Solution for injection | Sheep and cattle
  Not permitted for use in lactating ewes or cows used to produce milk for human consumption | Not specified in the SPC | Sheep:
  300 μg/kg bw
  Cattle:
  200 μg/kg bw | Meat:
  Cattle: 70 days
  Sheep: 56 days
  Milk:
  Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving |
| ICELAND | Pfizer A/S Vestre Gade
  DK-18 2650 Hvidovre | Dextomax | 1 % | Solution for injection | Cattle esp. bullocks, Not for use in lactating cows producing milk for human consumption, even in the resting period
  Sheep: Not for use in dairy ewes producing milk for human consumption. Not for use in pregnant ewes
  Pigs | Single dose | Cattle:
  200 μg/kg bw (sc)
  Sheep:
  200 μg/kg bw (sc, im)
  Pigs: 300 μg/kg bw
  Small pigs < 16 kg:
  < 4 kg: 0,1 ml
  5-7 kg: 0,2 ml
  8-10 kg: 0,3 ml
  11-13 kg: 0,4 ml
  14-16 kg: 0,5 ml | Meat:
  Cattle: 45 days.
  Sheep: 35 days
  Milk:
  Cattle: Not to be used for pregnant cows 60 days before giving birth.
  Sheep: Not to be used in dairy ewes, for at least 70 days before giving birth, if the milk is going to be used for human consumption |
| NORWAY | Pfizer As, Norway
  Orion Pharma As Animal Health
  PO Box 52
  N-0508 Oslo | Dectomax | 10 mg/ml | Solution for injection | Cattle, sheep, pigs, reindeer
  Not for use in lactating cattle, ewes or reindeer used to produce milk for human consumption | Not specified in the SPC | Cattle and reindeer:
  200 μg/kg bw
  Sheep:
  200 μg/kg bw (sc, im), (Nematodirus
  300 μg/kg bw (sc, im))
  Pigs:
  300 μg/kg bw | Meat:
  Cattle and reindeer: 42 days
  Sheep: 45 days (im), 60 days (sc) - Nematodirus battus 55 days (im), 70 days (sc)
  Pigs: Meat: 49 days
  Milk:
  Cattle: Not for use in the last 60 days before calving.
  Sheep: Not for use in the last 70 days before lambing |

Member State

Marketing authorisation holder

Product trade name

Strength

Pharma-ceutical form

Animal species

Frequency

Recommended dose

Withdrawal period

(meat and milk)

AUSTRIA

Pfizer Corp. Austria

Seidengasse 33-35

A-1071 Wien

Dectomax 1 % Injektions-lösung für Rinder und Schafe

10 mg/ml

Solution for injection

Cattle and sheep

No treatment of animals producing milk for human consumption

Single dose

200 μg/kg bw

Meat:

Cattle: 42 days

Sheep: 40 days

BELGIUM

Pfizer Animal Health S.A.

Rue Laid Burniat 1

B-1348 Louvain-la-Neuve

Dectomax

10 mg/ml

Solution for injection

Cattle and sheep

Single dose

200 μg/kg bw

Meat:

Cattle: 42 days

Sheep: 35 days

Milk:

Cattle: 60 days

Sheep: 70 days

DENMARK

Pfizer Aps

Lautrupvang 8

DK 2750 Ballerup

Dectomax Vet

DK MT NO 15721

10 mg/ml

Solution for injection

Cattle

Not to be used in cattle producing milk for human consumption.

Single dose

200 μg/kg bw

Meat:

45 days

Milk:

Not to be used later than 60 days prior to expected calving.

FINLAND

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

Dectomax Vet

10 mg/ml

Solution for injection

Cattle, Reindeer, Pigs

Not permitted for use in animals producing milk for human consumption during lactation

Single dose

Cattle and reindeer:

200 μg/kg bw

Swine:

300 μg/kg bw

Meat:

Cattle and reindeer: 42 days

Swine: 49 days

Milk:

Withdrawal period for milk 60 days for heifers, reindeer and animals during the dry period

FRANCE

Pfizer

23/25 Ave du docteur Lannelongue

F-75014 Paris

Dectomax

10 mg/ml

Solution for injection

Cattle and sheep

Not for use in dairy cows during lactating or drying off and not for use in dairy ewes

Single dose

Cattle:

200 μg/kg bw (sc only)

Sheep:

200 μg/kg bw (sc or im)

Meat:

Cattle: 42 days

Sheep: 35 days (im), 56 days (sc)

GERMANY

Pfizer GmbH

Pfizerstraße 1

D-76139 Karlsruhe

Dectomax

10 mg/ml

Solution for injection

Cattle and sheep

Not permitted for use in lactating animals producing milk for human consumption

Single dose

200 μg/kg bw

Meat:

Cattle, sheep: 60 days

GREECE

Pfizer Hellas

Alketou 5

GR-11633 Pagrati — Athina

Dectomax

10 mg/ml

Solution for injection

Sheep

Cattle

Not for use in dairy cows

Pigs

Single dose

Sheep:

200 μg/kg bw (sc, im)

Cattle:

200 μg/kg bw (sc)

Pigs:

300 μg/kg bw (im)

Meat:

Sheep: 35 days

Cattle: 42 days

Pigs: 49 days

Milk:

Sheep: Do not use in dairy sheep, including pregnant ewes within 50 days of lambing

Cattle: Do not use in non lactating dairy cows including pregnant dairy heifers within 60 days of calving

IRELAND

Pfizer Ltd.

Walton Oaks,

Dorking Road

Tadworth, Surrey KT20 7NT United Kingdom

Dectomax 1 %

Injectable solution

10 mg/ml

Solution for injection

Cattle and sheep

Single dose

Cattle: 200 μg/kg bw

Sheep: 300 μg/kg bw

Meat

Cattle: 63 days

Sheep: 63 days

ITALY

Pfizer Italia SRL

Via Valbondione 113

I-00188 Roma

Dectomax 1 %

(doramectin)

10 mg/ml

Solution for injection

Cattle, sheep and pigs

Use not permitted in animals producing milk for human use

Single dose

Cattle and sheep:

200 μg/kg bw

Pigs:

300 μg/kg bw

Meat:

Cattle: 42 days

Sheep: 35 days

Pigs: 37 days

LUXEMBOURG

Pfizer Animal Health

Rue Laid Burniat 1

B-1348 Louvain-la-Neuve

Dectomax

10 mg/ml

Injection

Cattle and sheep

Not for use in cattle producing milk for human consumption.

Not for use in sheep producing milk for human consumption

Single dose

Cattle:

200 μg/kg bw (sc)

Sheep:

300 μg/kg bw (sc or im)

Meat:

Cattle: 42 days

Sheep: 35 days

Milk:

Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving.

Sheep: Not for use in the last 70 days before lambing

THE NETHERLANDS

Pfizer Animal Health BV

PO Box 37

2900 AA Capelle aan den IJssel

Nederland

Dectomax (REG NL 9844)

Prontax (REG NL 9884)

10 mg/ml

Solution for injection

Non-lactating cattle and sheep,

pigs

Single dose. Sheep; repeated if signs of P.ovis infection do not disappear in 14 days

Cattle and sheep: 200 μg/kg bw Pigs: 300 μg/kg bw

Meat:

Cattle: 75 days

Sheep: 70 days

Pigs: 77 days

Milk:

Cattle and sheep: product not allowed for milking sheep.

PORTUGAL

Laboratórios Pfizer, Lda

Lagoas Park

Edifício 10

P-2740-244 Porte Salvo

Dectomax solution injectable

10 mg/ml

Solution for injection

Cattle, sheep and pigs

Single dose

Cattle and sheep:

200 μg/kg bw

Pigs:

300 μg/kg bw

Meat:

Cattle: 42 days

Sheep: 35 days

Pigs: 56 days

Milk:

Cattle: Forbidden in lactating cows, not to be administered 60 days before calving

Sheep: Forbidden in lactating sheep, not to be administered 70 days before lambing

SPAIN

Pfizer

Av da. De Europa, 20b

Parque Empresarial La Moraleja

E-28108 Alcobendas

Dectomax solution injectable

10 mg/ml

Solution for injection

Cattle and sheep

Single dose

200 μg/kg bw

Meat

Cattle: 42 days

Sheep: 60 days

SWEDEN

Pfizer AB

Box 501

S-183 25 Täby

Dectomax vet

10 mg/ml

Solution for injection

Cattle, sheep, (reindeer)

Not specified in the SPC

Catt1e (and reindeer):

200 μg/kg bw (sc)

Sheep:

200 μg/kg bw (sc or im)

Meat:

Cattle: 49 days

Sheep: 45 days (im); 60 days (sc)

Reindeer: 42 days

Milk:

Cattle: forbidden in lactating cows, not to be administered less than 60 days before calving

Sheep: forbidden in lactating sheep, not to be administered less than 70 days before lambing

UNITED KINGDOM

Pfizer Ltd

Pfizer Ltd, Sandwich, Kent CT13 9NJ,

United Kingdom

Dectomax Injectable Solution for Cattle and Sheep

10mg/ml

Solution for injection

Sheep and cattle

Not permitted for use in lactating ewes or cows used to produce milk for human consumption

Not specified in the SPC

Sheep:

300 μg/kg bw

Cattle:

200 μg/kg bw

Meat:

Cattle: 70 days

Sheep: 56 days

Milk:

Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving

ICELAND

Pfizer A/S Vestre Gade

DK-18 2650 Hvidovre

Dextomax

1 %

Solution for injection

Cattle esp. bullocks, Not for use in lactating cows producing milk for human consumption, even in the resting period

Sheep: Not for use in dairy ewes producing milk for human consumption. Not for use in pregnant ewes

Pigs

Single dose

Cattle:

200 μg/kg bw (sc)

Sheep:

200 μg/kg bw (sc, im)

Pigs: 300 μg/kg bw

Small pigs < 16 kg:

< 4 kg: 0,1 ml

5-7 kg: 0,2 ml

8-10 kg: 0,3 ml

11-13 kg: 0,4 ml

14-16 kg: 0,5 ml

Meat:

Cattle: 45 days.

Sheep: 35 days

Milk:

Cattle: Not to be used for pregnant cows 60 days before giving birth.

Sheep: Not to be used in dairy ewes, for at least 70 days before giving birth, if the milk is going to be used for human consumption

NORWAY

Pfizer As, Norway

Orion Pharma As Animal Health

PO Box 52

N-0508 Oslo

Dectomax

10 mg/ml

Solution for injection

Cattle, sheep, pigs, reindeer

Not for use in lactating cattle, ewes or reindeer used to produce milk for human consumption

Not specified in the SPC

Cattle and reindeer:

200 μg/kg bw

Sheep:

200 μg/kg bw (sc, im), (Nematodirus

300 μg/kg bw (sc, im))

Pigs:

300 μg/kg bw

Meat:

Cattle and reindeer: 42 days

Sheep: 45 days (im), 60 days (sc) - Nematodirus battus 55 days (im), 70 days (sc)

Pigs: Meat: 49 days

Milk:

Cattle: Not for use in the last 60 days before calving.

Sheep: Not for use in the last 70 days before lambing

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ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing authorisation holder | Applicant | Invented name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| THE NETHERLANDS | Guerbet | | Artirem | 0,0025 mmol/ml | Solution for injection | Intra-articular use | 0,0025 mmol/ml |
| GERMANY | | Guerbet | Artirem | 0,0025 mmol/ml | Solution for injection | Intra-articular use | 0,0025 mmol/ml |

Member State

Marketing authorisation holder

Applicant

Invented name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

THE NETHERLANDS

Guerbet

Artirem

0,0025 mmol/ml

Solution for injection

Intra-articular use

0,0025 mmol/ml

GERMANY

Guerbet

Artirem

0,0025 mmol/ml

Solution for injection

Intra-articular use

0,0025 mmol/ml

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