Summary of Community decisions on marketing authorisations in respect of medicinal products from 15.3.2005 to 15.4.2005(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2005-05-19
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, veterinary drug

19.5.2005

EN

Official Journal of the European Union

C 118/1

I

(Information)

COMMISSION

SUMMARY OF COMMUNITY DECISIONS ON MARKETING AUTHORISATIONS IN RESPECT OF
MEDICINAL PRODUCTS FROM 15.3.2005 TO 15.4.2005

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

29.3.2005

29.3.2005

Paroxetine

See Annex I

See Annex I

31.3.2005

Doramectin

See Annex II

See Annex II

Artirem

See Annex III

See Annex III

1.4.2005

1.4.2005

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

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

Allen Pharmazeutika GesmbH
Albert Schweitzer Gasse 6
A-1140 Wien

Arcana Arzneimittel GmbH
Zimbagasse 5
A-1147 Wien

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl/Tirol

GlaxoSmithKline Pharma GmbH
Albert Schweitzer Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert Schweitzer Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert Schweitzer Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert Schweitzer Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert Schweitzer Gasse 6
A-1140 Wien

Allenopar 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Allen’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Arcana’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paluxetil 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Seroxat 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Seroxat 2 mg/ml — oral suspension

2 mg/ml

Oral suspension

Oral use

Glaxopar 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroglax 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin ‘GSK’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

AUSTRIA
(cont'd)

BELGIUM

Hexal Pharma GmbH
Wilhelminestraße 91/IIf/3
A-1160 Wien

Hexal Pharma GmbH
Wilhelminestraße 91/IIf/3
A-1160 Wien

Interpharm Produktions GmbH
Effingergasse 21
A-1160 Wien

Lannacher Heilmittel GmbH
Schlossplatz 1
A-8502 Lannach

Ratiopharm Arzneimittel Vertriebs — GmbH
Albert Schweitzer Gasse 3
A-1140 Wien

Ratiopharm Arzneimittel Vertriebs — GmbH
Albert Schweitzer Gasse 3
A-1140 Wien

Stada Arzneimittel GmbH
Heiligenstädter Str. 52
A-1190 Wien

Bexal
Av J. Bordet 168
B-1140 Brussels

Bexal
Av J. Bordet 168
B-1140 Brussels

Eurogenerics NV
Heizel Esplanade Heysel B 22
B-1020 Brussel

Paroxat 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxat 40 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Interpharm’ Filmtabletten

20 mg

Film-coated tablet

Oral use

Ennos 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Merckle’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin ‘ratiopharm’ 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Parocetan 20 mg — Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetine Bexal 20 mg

20 mg

Film-coated tablet

Oral use

Paroxetine Bexal 40 mg

40 mg

Film-coated tablet

Oral use

Paroxetine EG 20 mg

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
3

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

BELGIUM
(cont'd)

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Ratiopharm Belgium SA/NV
Rue Aaint-Lambert 141
B-1200 Bruxelles

Merck SA/NV
Brusselsesteenweg 288
B-3090 Overijse

Aropax

Aropax

Aropax
Suspension orale

Seroxat

Seroxat

20 mg

Tablet

Oral use

30 mg

Tablet

Oral use

2 mg/ml

Oral suspension

Oral use

20 mg

Tablet

Oral use

30 mg

Tablet

Oral use

Seroxat Suspension orale

2 mg/ml

Oral suspension

Oral use

Parocetan 20 mg

20 mg

Film-coated tablet

Oral use

Paroxetiphar 20 mg

20 mg

Film-coated tablet

Oral use

Paroxetine — Ratiopharm 20 mg

20 mg

Film-coated tablet

Oral use

Merck — Paroxetine 20 mg

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

CYPRUS

CZECH REPUBLIC

Medochemie Ltd
1-10 Constantinoupoleos str.
PO Box 51407
3505 Lemesos
Cyprus

Medochemie Ltd
1-10 Constantinoupoleos str.
PO Box 51407
3505 Lemesos
Cyprus

C.A. Papaellinas & Co. Ltd
161 Old Lefkosia-Lemesos Road
PO Box 24018
1700 Lefkosia
Cyprus

C.A. Papaellinas & Co. Ltd
161 Old Lefkosia-Lemesos Road
PO Box 24018
1700 Lefkosia
Cyprus

Apotex Europe Ltd
Rowan House 41 London Street
Reading
Berkshire RG1 4PS
United Kingdom

Hexal A/S
Kanalholmen 8-12
DK-2650 Hvidovre

Hexal A/S
Kanalholmen 8-12
DK-2650 Hvidovre

Ratiopharm GmbH
Graf-Arco-Straße 3
D-890 79 Ulm

Arketis

20 mg

Film-coated tablet

Oral use

Arketis

30 mg

Film-coated tablet

Oral use

Seroxat

20 mg

Tablet

Oral use

Seroxat

30 mg

Tablet

Oral use

Apo-Parox

20 mg

Film-coated tablet

Oral use

Parolex 20

20 mg,

Film-coated tablet

Oral use

Parolex 40

40 mg

Film-coated tablet

Oral use

Paroxetin-Ratiopharm 20 mg

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

CZECH REPUBLIC
(cont'd)

Chemical works of Gedeon Richter Ltd
Gyömröi út 19-21
H-1103 Budapest

Remood 20 mg

20 mg

Film-coated tablet

Oral use

DENMARK

Chemical works of Gedeon Richter Ltd
Gyömröi út 19-21
H-1103 Budapest

Smithkline Beecham Pharmaceuticals
New Horizont Court,
TW8 9EP Brentford,
Middlesex
United Kingdom

Smithkline Beecham Pharmaceuticals
New Horizont Court,
TW8 9EP Brentford,
Middlesex
United Kingdom

1A Farma A/S
Herstedøstervej 27-29
DK-2620 Albertslund

1A Farma A/S
Herstedøstervej 27-29
DK-2620 Albertslund

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Remood 30 mg

30 mg

Film-coated tablet

Oral use

Seroxat 20 mg

20 mg

Film-coated tablet

Oral use

Seroxat 30 mg

30 mg

Film-coated tablet

Oral use

Paroxetine ‘1A Farma’

20 mg

Film-coated tablet

Oral use

Paroxetine ‘1A Farma’

40 mg

Film-coated tablet

Oral use

Oxetine

20 mg

Film-coated tablet

Oral use

Paroxetin ‘GEA’

20 mg

Film-coated tablet

Oral use

Paroxetin ‘GEA’

40 mg

Film-coated tablet

Oral use

Paroc

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

DENMARK
(cont'd)

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Paroc

40 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Alpharma AS
Harbitzalléen 3
N-Skøyen, 0212 Oslo

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

Paroneurin

20 mg

Film-coated tablet

Oral use

Paroneurin

40 mg

Film-coated tablet

Oral use

Optipar

Optipar

Roxac

Roxac

20 mg

Film-coated tablet

Oral use

40 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

40 mg

Film-coated tablet

Oral use

Paroxetin ‘Alpharma’

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Biochemie’

20 mg

Film-coated tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
7

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

DENMARK
(cont'd)

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

Generics (UK) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Generics (UK) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Genthon BV
Microweg 22
6545 CM Nijmegen
Nederland

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

Serodur

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Generics’

20 mg

Film-coated tablet

Oral use

Pasero

20 mg

Film-coated tablet

Oral use

Paroxetin
‘Genthon’

Seroxat

Seroxat

Seroxat

20 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

2 mg/ml

Oral suspension

Oral use

C

1
1
8
/
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

DENMARK
(cont'd)

NM Pharma A/S
Lautrupvang 8
DK-2750 Ballerup

NM Pharma A/S
Lautrupvang 8
DK-2750 Ballerup

PharmaCoDane Aps
Marielundvej 46 A
DK-2730 Herlev

Copyfarm A/S
Energivej 15
DK-5260 Odense S

Copyfarm A/S
Energivej 15
DK-5260 Odense S

Pharmascope Ltd.
Unit 107
Ashbourne Industrial Estate
Co. Meath
Ireland

Pharmascope Ltd.
Unit 107
Ashbourne Industrial Estate
Co. Meath
Ireland

Pharmascope Ltd.
Unit 107
Ashbourne Industrial Estate
Co. Meath
Ireland

Paroxetin ‘NM’

20 mg

Film-coated tablet

Oral use

Paroxetin ‘NM’

30 mg

Film-coated tablet

Oral use

Paroxetin ‘PCD’

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Copyfarm’

20 mg

Film-coated tablet

Oral use

Paroxetine ‘Copyfarm’

30 mg

Film-coated tablet

Oral use

Meparox

20 mg

Film-coated tablet

Oral use

Meparox

30 mg

Film-coated tablet

Oral use

Paroscope

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
9

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

DENMARK
(cont'd)

Pharmascope Ltd.
Unit 107
Ashbourne Industrial Estate
Co. Meath
Ireland

United Nordic Pharma A/S
Hammervej 7
DK-2970 Hørsholm

United Nordic Pharma A/S
Hammervej 7
DK-2970 Hørsholm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Scand Pharm Generics AB
Ynglingagatan 14, 5tr
S-11347 Stockholm

Paroscope

30 mg

Film-coated tablet

Oral use

Paroxetin ‘UNP’

20 mg

Film-coated tablet

Oral use

Paroxetin ‘UNP’

30 mg

Film-coated tablet

Oral use

Paroxegen

20 mg

Film-coated tablet

Oral use

Paroxegen

30 mg

Film-coated tablet

Oral use

Paroxetin ‘Ratiopharm’

20 mg

Film-coated tablet

Oral use

Sopax

Pasorex

Serorex

20 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
1
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

DENMARK
(cont'd)

Scand Pharm Generics AB
Ynglingagatan 14, 5tr
S-11347 Stockholm

Scand Pharm Generics AB
Ynglingagatan 14, 5tr
S-11347 Stockholm

Synthon BV
Microweg 22
6545 CM Nijmegen
Nederland

Synthon BV
Microweg 22
6545 CM Nijmegen
Nederland

Synthon BV
Microweg 22
6545 CM Nijmegen
Nederland

Synthon BV
Microweg 22
6545 CM Nijmegen
Nederland

Glaxo Group Ltd
Berkeley Avenue,
Greenford
Middlesex TW8 9GS
United Kingdom

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

ESTONIA

Serorex

30 mg

Film-coated tablet

Oral use

Seroxetabs

20 mg

Film-coated tablet

Oral use

Euplix

20 mg

Film-coated tablet

Oral use

Paroxetin ‘Synthon’

20 mg

Film-coated tablet

Oral use

Parsyn

20 mg

Film-coated tablet

Oral use

Varoxetin

20 mg

Film-coated tablet

Oral use

Paroxat

20 mg

Film-coated tablet

Oral use

Paroxetinhexal 20

20 mg

Tablet

Oral use

Paroxetinhexal 40

40 mg

Tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
1
1

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

ESTONIA
(cont'd)

Richter
Gyömröi ut 19-21
H-1103 Budapest X

Rexetin

20 mg

Tablet

Oral use

Richter
Gyömröi ut 19-21
H-1103 Budapest X

SmithKline Beecham
980 Great West Road, Brentford
Middlesex TW8 9GS
United Kingdom

SmithKline Beecham
980 Great West Road, Brentford
Middlesex TW8 9GS
United Kingdom

FINLAND

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Genthon BV
Microweg 22
6545 CM
Nijmegen
Nederland

Pharmcom Oy
Keijumaki 6B 30
FIN-02130 Espoo

Rexetin 30 mg

30 mg

Tablet

Oral use

Seroxat

20 mg

Tablet

Oral use

Seroxat

30 mg

Coated tablet

Oral use

Optipar

Optipar

Euplix

20 mg

Film-coated tablet

Oral use

40 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

Parox

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
1
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

FINLAND
(cont'd)

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Paroxetin ratiopharm

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

FRANCE

SmithKline Beecham Plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

SmithKline Beecham Plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

STADA Arzneimittel AG
Stadastraße 2-18
D-61118 Bad Vilbel

Chiesi SA
11 Avenue Dubonnet
F-92400 Courbevoie

Laboratoires G GAM
Europarc
33 rue Auguste Perret
F-94042 Creteil Cedex

Laboratoires G GAM
Europarc
33 rue Auguste Perret
F-94042 Creteil Cedex

Laboratoire GlaxoSmithKline
100 route de Versailles
F-78163 Marly-le-Roy

Laboratoire GlaxoSmithKline
100 route de Versailles
F-78163 Marly-le-Roy

Seroxat

20 mg

Film-coated tablet

Oral use

Seroxat

2 mg/ml

Oral suspension

Oral use

Paroxetin Stada

20 mg

Film-coated tablet

Oral use

Divarius

20 mg

Coated tablet

Oral use

Paroxetine G GAM

20 mg

Coated tablet

Oral use

Paroxetine G GAM

40 mg

Coated tablet

Oral use

Deroxat

Deroxat

20 mg

Coated tablet

Oral use

20 mg/10 ml

Oral suspension

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
1
3

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

FRANCE
(cont'd)

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

Laboratoire Paucourt
100 route de Versailles
F-78163 Marly-le-Roy

KIRON Pharmaceutica BV
Groesbeekseweg 11
6524 CK Nijmegen,
Nederland

Merck Generiques
34 rue Saint Romain
F-69359 Lyon Cedex 08

Qualimed
34 rue Saint Romain
F-69359 Lyon Cedex 08

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Laboratoire Saint-Germain
100 route de Versailles
F-78163 Marly-le Roy

Paroxetine GSK

20 mg/10 ml

Oral suspension

Oral use

Paroxetine Paucourt

20 mg/10 ml

Oral suspension

Oral use

Paroxetine Kiron

20 mg

Coated tablet

Oral use

Paroxetine Merck

20 mg

Coated tablet

Oral use

Paroxetine Qualimed

20 mg

Coated tablet

Oral use

Paroxetine Ratiopharm

20 mg

Coated tablet

Oral use

Paroxetine Saint Germain

20 mg/10 ml

Oral suspension

Oral use

C

1
1
8
/
1
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

GERMANY

1 A Pharma GmbH
Keltenring 1+3
D-82041 Oberhaching

1 A Pharma GmbH
Keltenring 1+3
D-82041 Oberhaching

AbZ-Pharma GmbH
Dr. Georg-Spohn-Str. 7
D-89143 Blaubeuren

STADA Arzneimittel AG
Stadastraße 2 — 18
D-61118 Bad Vilbel

Aliud Pharma GmbH & Co.KG
Gottlieb-Daimler-Str. 19
D-89150 Laichingen

Alpharma-ISIS GmbH & Co.KG
Elisabeth-Selbert-Str. 1
D-40764 Langenfeld

AWD.Pharma GmbH & Co.KG
Leipziger Str. 7-13
D-01097 Dresden

Azupharma GmbH & Co.
Dieselstr. 5
D-70839 Gerlingen

Betapharm Arzneimittel GmbH
Kobelweg 95
D-86156 Augsburg

Paroxetin — 1A Pharma40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

Paroxetin — 1 A Pharma 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin AbZ 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin AL 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin Aliud 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin-Isis 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Oxet 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin AZU 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin beta 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
1
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

GERMANY
(cont'd)

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

Falken-Apotheke
Dr. Klaus Hultzsch, Kirchhohl 14
D-65207 Wiesbaden

Falken-Apotheke
Dr. Klaus Hultzsch, Kirchhohl 14
D-65207 Wiesbaden

Falken-Apotheke
Dr. Klaus Hultzsch, Kirchhohl 14
D-65207 Wiesbaden

Esparma GmbH
Lange Göhren 3
D-39171 Osterweddingen

Biomo pharma GmbH
Lendersberstr. 86
D-53721 Siegburg

Falken-Apotheke
Dr. Klaus Hultzsch, Kirchhohl 14
D-65207 Wiesbaden

Falken-Apotheke
Dr. Klaus Hultzsch, Kirchhohl 14
D-65207 Wiesbaden

Paroxetin von ct 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Depar

Genpar

Osepar

20 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

Aroxetin

20 mg

Film-coated tablet

Oral use

Paroxetin-biomo 20 mg

20 mg

Film-coated tablet

Oral use

Trapar

Zwapar

20 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
1
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

GERMANY
(cont'd)

Generics (UK) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Pasero 20 mg, Filmtabletten

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München

Heumann Pharma GmbH
Südwestpark 50
D-90449 Nürnberg

Hexal AG
Industriestr. 25
D-83607 Holzkirchen

Hexal AG
Industriestr. 25
D-83607 Holzkirchen

Hexal AG
Industriestr. 25
D-83607 Holzkirchen

Seroxat Filmtabletten

20 mg

Film-coated tablet

Oral use

Seroxat Suspension

2 mg/ml

Oral suspension

Oral use

Tagonis Filmtabletten

20 mg

Film-coated tablet

Oral use

Tagonis Suspension

2 mg/ml

Oral suspension

Oral use

Paroxetin, Heumann 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroc 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroc 40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

Paroxat 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
1
7

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

GERMANY
(cont'd)

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

Hexal AG
Industriestr. 25
D-83607 Holzkirchen

Roxac 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

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

Lindopharm GmbH
Neustr. 82
D-40721 Hilden

Merck dura GmbH
Frankfurter Str. 133
D-64293 Darmstadt

Merck dura GmbH
Frankfurter Str. 133
D-64293 Darmstadt

Paroxetin Lindo 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin Lindo 40 mg Filmtabletten

40 mg

Film-coated tablet

Oral use

Paroxedura 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxedura 30 mg

30 mg

Film-coated tablet

Oral use

C

1
1
8
/
1
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

GERMANY
(cont'd)

Neuraxpharm Arzneimittel GmbH & Co KG
Elisabeth-Selbert-Str. 23
D-40764 Langenfeld

Paroxetin-neuraxpharm 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München

Stadapharm GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Synthon B.V.
Microweg 22
6545 CM Nijmegen
Nederland

TAD Pharma GmbH
Heinz-Lohmann-Str. 5
D-27472 Cuxhaven

Paroxetin-ratiopharm 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin-ratiopharm 30 mg Filmtabletten

30 mg

Film-coated tablet

Oral use

Oxepar Suspension

2 mg/ml

Oral suspension

Oral use

Paxil Filmtabletten

20 mg

Film-coated tablet

Oral use

Paxil Suspension

2 mg/ml

Oral suspension

Oral use

Paroxetin STADA 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Euplix 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Paroxetin TAD 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
1
9

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

GREECE

GlaxoSmithKline A.E.B.E.
266 Kifissias Avenue
GR-15232 Chalandri, Athens

HUNGARY

GlaxoSmithKline A.E.B.E.
266 Kifissias Avenue
GR-15232 Chalandri, Athens

GlaxoSmithKline A.E.B.E.
266 Kifissias Avenue
GR-15232 Chalandri, Athens

Apotex Europe Ltd.
Rowan House
41 London Street
RG 14 Berkshire
United Kingdom

Hexal Hungária Kft.
Tímár u.20.
H-1034 Bp

Hexal Hungária Kft.
Tímár u.20.
H-1034 Bp

Seroxat

Seroxat

Seroxat

20 mg

Tablet

Oral use

30 mg

Tablet

Oral use

10 mg/5 ml

Oral suspension

Oral use

Apodepi filmtabletta

20 mg

Film-coated tablet

Oral use

Paretin 20 mg filmtabletta

20 mg

Film-coated tablet

Oral use

Paretin 40 mg filmtabletta

40 mg

Film-coated tablet

Oral use

C

1
1
8
/
2
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

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

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

HUNGARY
(cont'd)

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

Richter Gedeon Rt.
Gyömrői út 19-21.
H-1103 Bp

Richter Gedeon Rt.
Gyömrői út 19-21.
H-1103 Bp

Paroxetin ratiopharm 20 mg filmtabletta

20 mg

Film-coated tablet

Oral use

Rextine 20 mg filmtabletta

20 mg

Film-coated tablet

Oral use

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

Genthon BV
Microweg 22
6545 CM, Nijmegen
Nederland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way, Rathfarnham
Dublin 16
Ireland

Paroxetine Tablets 40 mg

40 mg

Tablet

Oral use

Meloxat

20 mg

Film-coated tablet

Oral use

Paroxetine 2 mg/ml

2 mg/ml

Oral solution

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
2
1

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

IRELAND
(cont'd)

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

Rowex Limited
Newtown
Bantry, Co. Cork
Ireland

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

Paroxetine Tablets 30 mg

30 mg

Tablet

Oral use

Parox Tablets 20 mg

20 mg

Tablet

Oral use

Seroxat Tablets 20 mg

20 mg

Tablet

Oral use

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

C

1
1
8
/
2
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

ICELAND

Gerard Laboratories
35/36 Baldoyle
Industrial Estate
Grange Road, Dublin 13
Ireland

Paroxetin NM Pharma

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

GlaxoSmithKline ehf
Thverholt 14
P.O.Box 5499
125 Reykjavik
Iceland

GlaxoSmithKline ehf
Thverholt 14
P.O.Box 5499
125 Reykjavik
Iceland

Omega Farma ehf
Skútuvogi 1H
104 Reykjavik
Iceland

Omega Farma ehf
Skútuvogi 1H
104 Reykjavik
Iceland

Omega Farma ehf
Skútuvogi 1H
104 Reykjavik
Iceland

Synthon BV
Microweg 22
6545 CM
Nijmegen
Nederland

Seroxat

20 mg

Tablet

Oral use

Seroxat

2 mg/ml

Mixture

Oral use

Paroxat

10 mg

Tablet

Oral use

Paroxat

20 mg

Tablet

Oral use

Paroxat

30 mg

Tablet

Oral use

Euplix

20 mg

Tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
2
3

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

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

Abbot S.p.A.
Via Pontina KM 52,
I-04010 Campo Verde (Aprilia), Latina

GlaxoSmithKline S.p.A.
Via Fleming 2
I-37135 Verona

GlaxoSmithKline S.p.A.
Via Fleming 2
I-37135 Verona

Merck Generics Italia Spa
Via Aquileia 35
Cinisello Balsamo

Synthon BV,
Microweg 22,
6545 CM Nijmegen
Nederland

Sereupin

Sereupin

Seroxat

Seroxat

20 mg

Tablet

Oral use

2 mg/ml

Oral suspension

Oral use

20 mg

Tablet

Oral use

2 mg/ml

Oral suspension

Oral use

Paroxetina Merck Generics

20 mg

Film-coated tablet

Oral use

Daparox

20 mg

Tablet

Oral use

Valda Laboratori Farmaceutici S.p.A.
Via Zambeletti
I-20021 Baranzate Di Bollate, Milano

Valda Laboratori Farmaceutici S.p.A.
Via Zambeletti
I-20021 Baranzate Di Bollate, Milano

Eutimil

Eutimil

20 mg

Tablet

Oral use

2 mg/ml

Oral suspension

Oral use

C

1
1
8
/
2
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

LATVIA

Medochemie Ltd
P.O. Box 51409
CY-3505 Limassol
Cyprus

Glaxo Group Limited
Greenford
Middlesex
UB6 0NN
United Kingdom

Glaxo Group Limited
Greenford
Middlesex
UB6 0NN
United Kingdom

Glaxo Group Limited
Greenford
Middlesex
UB6 0NN
United Kingdom

Glaxo Group Limited
Greenford
Middlesex
UB6 0NN
United Kingdom

Glaxo Group Limited
Greenford
Middlesex
UB6 0NN
United Kingdom

Glaxo Group Limited
Greenford
Middlesex
UB6 0NN
United Kingdom

Arketis

Paroxat

20 mg

Tablet

Oral use

10 mg

Coated tablet

Oral use

Paroxat

20 mg

Coated tablet

Oral use

Paroxat

30 mg

Coated tablet

Oral use

Seroxat

10 mg

Coated tablet

Oral use

Seroxat

20 mg

Coated tablet

Oral use

Seroxat

30 mg

Coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
2
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

LATVIA
(cont'd)

LITHUANIA

Gedeon Richter Ltd
Gyomroi 19-21
H-1103 Budapest

Gedeon Richter Ltd
Gyomroi 19-21
H-1103 Budapest

Hexal AG
Industriestraße 25
Holzkirchen
D-83607

Hexal AG
Industriestraße 25
Holzkirchen
D-83607

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

Gedeon Richter Ltd.
Gyomroi ut 19-24
H-1103 Budapest

Gedeon Richter Ltd.
Gyomroi ut 19-24
H-1103 Budapest

SmithKline Beecham plc
SB House, Great West road, Brentford, Middlesex
United Kingdom

SmithKline Beecham plc
SB House, Great West road, Brentford, Middlesex
United Kingdom

Rexetin

Rexetin

20 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

ParoxetinHexal

20 mg

Coated tablet

Oral use

ParoxetinHexal

40 mg

Coated tablet

Oral use

ParoxetinHexal

20 mg

Film-coated tablet

Oral use

ParoxetinHexal

40 mg

Film-coated tablet

Oral use

Rexetin

Rexetin

Seroxat

Seroxat

20 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

C

1
1
8
/
2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

LUXEMBOURG

GlaxoSmithKline S.A/N.V.
Rue du Tilleul, 13
B-1332 Genval

GlaxoSmithKline S.A/N.V.
Rue du Tilleul, 13
B-1332 Genval

GlaxoSmithKline S.A/N.V.
Rue du Tilleul, 13
B-1332 Genval

GlaxoSmithKline S.A/N.V.
Rue du Tilleul, 13
B-1332 Genval

GlaxoSmithKline S.A/N.V.
Rue du Tilleul, 13
B-1332 Genval

GlaxoSmithKline S.A/N.V.
Rue du Tilleul, 13
B-1332 Genval

Merck S.A.
288 Brusselsesteenweg
B-3090 Overijse

Aropax

Aropax

Aropax

Seroxat

Seroxat

Seroxat

20 mg

Tablet

Oral use

30 mg

Tablet

Oral use

20 mg/10 ml

Oral suspension

Oral use

20 mg

Tablet

Oral use

30 mg

Tablet

Oral use

20 mg/10 ml

Oral suspension

Oral use

Merck-Paroxetine
20 mg

20 mg

Tablet

Oral use

MALTA

Smithkline Beecham Plc
SB House Great West Road Bentford TW8 9BD
Middlesex United Kingdom

Actavis hf
Reykjavikurvegur 78
220
Hafnarfjordur

Seroxat

Paxetin

20 mg

Coated tablet

Oral use

20 mg

Tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
2
7

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

THE NETHERLANDS Centrafarm Services B.V

Paroxetine CF 20 mg

20 mg

Tablet

Oral use

Nieuwe Donk 9
P.O.Box 289
4870 AG Etten-Leur
Nederland

Genthon BV
Box 7071
GN Nijmegen
Nederland

GlaxoSmithKline BV
Huister Heideweg 62
P.O.Box 780
3700 AT Zeist
Nederland

GlaxoSmithKline BV
Huister Heideweg 62
P.O.Box 780,
3700 AT Zeist
Nederland

GlaxoSmithKline BV
Huister Heideweg 62
P.O.Box 780
3700 AT Zeist
Nederland

Hexal Pharma Nederland B.V
Pastoorslaan 28
P.O.Box 251
2182 BX Hillegom
Nederland

Hexal Pharma Nederland B.V
Pastoorslaan 28
P.O.Box 251
2182 BX Hillegom
Nederland

I.C.C. BV
P.O.Box 75
6920 AB Duiven
Nederland

Paroxetine 20 mg

20 mg

Film-coated tablet

Oral use

Seroxat Suspensie 2 mg/ml

2 mg/ml

Oral suspension

Oral use

Seroxat 20 mg tablets

20 mg

Tablet

Oral use

Seroxat 30 mg tablets

30 mg

Film-coated tablet

Oral use

Paroxetine 20 mg

20 mg

Film-coated tablet

Oral use

Paroxetine 40 mg

40 mg

Film-coated tablet

Oral use

Paroxetine
20 mg

20 mg

Tablet

Oral use

C

1
1
8
/
2
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

THE NETHERLANDS
(cont'd)

Merck Generics BV
Dieselweg 25
3752 LB Bunschoten
Nederland

Multipharma BV
Gemeenschapspolderweg 28
P.O.Box 216
1382 GR Weesp
Nederland

NORWAY

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl

Duranor AS
Oslo

GlaxoSmithKline AS
Forskningsveien 2a
Postbox 180 Vinderen
N-0319, Oslo

NM Pharma AS
Lilleakerveien, 2B, Oslo

Ratiopharm GmbH
Graf-Acro-Straße 3
D-89079 Ulm

STADA Arzneimittel AG
Stadastraße 2 — 18
D-61118 Bad Vilbel

Paroxetine
Merck 20 mg

MP-Paroxetine
20 mg

20 mg

Tablet

Oral use

20 mg

Film-coated tablet

Oral use

Paroxetine Gea

20 mg

Film-coated tablet

Oral use

Paroxetine Gea

40 mg

Film-coated tablet

Oral use

Paroxetin Biochemie

20 mg

Film-coated tablet

Oral use

Serodur

Seroxat

20 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Paroxetin NM Pharma

20 mg

Film-coated tablet

Oral use

Paroxetin Ratiopharm

20 mg

Film-coated tablet

Oral use

Paroxetin Stada

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
2
9

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

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

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Gedeon Richter Ltd
H-1103 Budapest, Gyömroi ut 19-21

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford, Middlesex
TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford, Middlesex
TW89GS
United Kingdom

Deprozel 20 mg

20 mg

Film-coated tablet

Oral use

Paxeratio

20 mg

Film-coated tablet

Oral use

Rexetin

Seroxat

20 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

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

C

1
1
8
/
3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

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

.

.

1
9
5
2
0
0
5

Alpharma ApS
Rua Virgílio Correia, 11-A
P-1600-219 Lisboa

Biara — Produtos Farmacêuticos, Lda.
Rua Ramalho Ortigão, 45-A
P-070-228 Lisboa

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

Farma APS — Produtos Farmacêuticos, SA
Rua José Galhardo no. 3, loja 3 -C/v
P-1750-131 Lisboa

Bexal Produtos Farmacêuticos SA
Rua Prof. Ricardo Jorge, 5 A
Miraflores
P-1495-153 Algés

Generis Farmacêutica, SA
Rua José Galhardo no. 3
P-1750-131 Lisboa

GlaxoSmithkline Produtos
Farmacêuticos, Lda.
Rua Dr. António Loureiro Borges, 3, Arquiparque
Miraflores
P-1495-131 Algés

Paroxetina Alpharma 20 mg Comprimidos

20 mg

Film-coated tablet

Oral use

Paroxetina Biara 20 mg Comprimidos Revestidos

20 mg

Film-coated tablet

Oral use

Paroxetina Sandoz 20 mg Comprimidos

20 mg

Film-coated tablet

Oral use

Paroxetina APS 20 mg Comprimidos Revestidos

20 mg

Film-coated tablet

Oral use

Paroxetina Bexal 20 mg Comprimido revestido por
película

20 mg

Film-coated tablet

Oral use

Paroxetina Generis 20 mg Comprimidos Revestidos

20 mg

Film-coated tablet

Oral use

Seroxat

20 mg

Film-coated tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
3
1

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

PORTUGAL
(cont'd)

GlaxoSmithkline Produtos Farmacêuticos, Lda.
Rua Dr. António Loureiro Borges, 3, Arquiparque
Miraflores
P-1495-131 Algés

Instituto Luso-Fármaco, Lda.
Rua Dr. António Loureiro Borges, 3, Arquiparque
Miraflores
P-1495-131 Algés

Seroxat

Calmus

Laboratórios Azevedos — Indústria Farmacêutica,
S.A.
Estrada Nacional 117-2
P-2724-503 Alfragide

Oxepar

2 mg/ml

Oral suspension

Oral use

20 mg

Film-coated tablet

Oral use

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

Medibial — Produtos Médicos e Farmacêuticos, SA
Av. Da Siderurgia Nacional
P-4745-457 S. Mamede do Coronado

Paxetil

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

2 mg/ml

Oral suspension

Oral use

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

C

1
1
8
/
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

PORTUGAL
(cont'd)

Ratiopharm - Comércio e Indústria de Produtos Farm-
acêuticos, 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

Tecnimede — Sociedade Técnico - Medicinal, SA
Rua Prof. Henrique de Barros
Edifício Sagres, 3oA
P-2685-338 Prior Velho

Parox

20 mg

Film-coated tablet

Oral use

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

A/S GEA Farmaceutisk Fabrik
Holger Danskaes Vej 89
DK-2000 Fraderiksberg

ratiopharm GmbH
Gras-Orco-Straße 3
D-89079 Ulm

Gedeon Richter Ltd.
Gyomroi út 19-21
H-1103 Budapest

Gedeon Richter Ltd.
Gyomroi út 19-21
H-1103 Budapest

Parolex 20

20 mg

Film-coated tablet

Oral use

Parolex 40

40 mg

Film-coated tablet

Oral use

Paroxetini-ratiopharm 20 mg

20 mg

Film-coated tablet

Oral use

Remood 20 mg

20 mg

Film-coated tablet

Oral use

Remood 30 mg

30 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
3
3

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

SLOVAC REPUBLIC
(cont'd)

SmithKlineBeecham Pharmaceuticals
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

SmithKlineBeecham Pharmaceuticals
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Seroxat 20 mg tbl flm

20 mg

Film-coated tablet

Oral use

Seroxat 30 mg tbl flm

30 mg

Film-coated tablet

Oral use

SLOVENIA

GlaxoSmithKline d.o.o., družba za promet s farma-
cevtskimi izdelki, Knezov štradon 90, Ljubljana

Paroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline d.o.o., družba za promet s farma-
cevtskimi izdelki, Knezov štradon 90, Ljubljana

Paroxat

30 mg

Film-coated tablet

Oral use

GlaxoSmithKline d.o.o., družba za promet s farma-
cevtskimi izdelki, Knezov štradon 90, Ljubljana

Seroxat

20 mg

Film-coated tablet

Oral use

GlaxoSmithKline d.o.o., družba za promet s farma-
cevtskimi 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

C

1
1
8
/
3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

SWEDEN

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Paroxetine GEA

20 mg

Film-coated tablet

Oral use

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

GlaxoSmithKline AB
Box 263,
SE-431 23 Mölndal

GlaxoSmithKline AB
Box 263,
SE-431 23 Mölndal

GlaxoSmithKline AB
Box 263,
SE-431 23 Mölndal

Paroxetin Scand
Pharm

20 mg

Film-coated tablet

Oral use

Seroxat

Seroxat

Paroxetin
ratiopharm

20 mg

Film-coated tablet

Oral use

2 mg/ml

Oral suspension

Oral use

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
3
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

SWEDEN
(cont'd)

GlaxoSmithKline AB
Box 263,
SE-431 23 Mölndal

GlaxoSmithKline AB
Box 263,
SE-431 23 Mölndal

GlaxoSmithKline AB
Box 263,
SE-431 23 Mölndal

Paroxat

Meradel

Eoxat

20 mg

Film-coated tablet

Oral use

20 mg

Tablet

Oral use

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

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Paroxetin
‘Medis’

20 mg

Film-coated tablet

Oral use

Paroxetabs

20 mg

Film-coated tablet

Oral use

Parotamed

20 mg

Film-coated tablet

Oral use

Paraxodil

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

SWEDEN
(cont'd)

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Primoxatine

20 mg

Film-coated tablet

Oral use

.

.

1
9
5
2
0
0
5

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Neuraxpharm Arzneimittel GmbH & Co. KG
Elisabeth-Selbert-Str. 23
D-40764 Langenfeld

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

STADA Arzneimittel AG
Stadastraße 2 — 18
D-61118 Bad Vilbel

STADA Arzneimittel AG
Stadastraße 2 — 18
D-61118 Bad Vilbel

STADA Arzneimittel AG
Stadastraße 2 — 18
D-61118 Bad Vilbel

Synthon BV
Microweg 22,
6545 CM Nijmegen
Nederland

TAD Pharma GmbH
Heinz-Lohmann-Straße 5
D-27472 Cuxhaven

Titroxatine

20 mg

Film-coated tablet

Oral use

Isoxatine

20 mg

Film-coated tablet

Oral use

Paroxin

20 mg

Film-coated tablet

Oral use

Parocetan

20 mg

Film-coated tablet

Oral use

Paroxiflex

20 mg

Film-coated tablet

Oral use

Paroxistad

20 mg

Film-coated tablet

Oral use

Euplix

20 mg

Film-coated tablet

Oral use

Medoxatine

20 mg

Film-coated tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
3
7

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

SPAIN

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Bexal Farmaceutica S.A.
Ventura Rodriguez 7, 5 planta
E-28008 Madrid

Laboratorios Davur S.L.
Teide, 4-planta baja
Poligono Empresarial La Marina
E-28700 San Sebastian de los Reyes,
Madrid

Faes Farma SA
Maximo Aguirre 14
E-48940 Lejona (Vizcaya)

Laboratorios Fournier SA
Ronda de Poniente 16
E-28760-Tres Cantos, Madrid

GlaxoSmithKline SA
Severo Ochoa 2
E-28760 Tres Cantos, Madrid

Laboratorios Alter SA
Mateo Inurria 30
E-28036 Madrid

Paroxetina Gea
20 mg

Paroxetina Gea
40 mg

Paroxetina Bexal
20 mg
comprimidos
EFG

Paroxetina
Davur 20 mg
Comprimidos
Recubiertos EFT

Motivan 20 mg,
comprimidos

20 mg

Film-coated tablet

Oral Use

40 mg

Film-coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

20 mg

Coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

Casbol 20 mg comprimidos con cubierta pelicular

20 mg

Film-coated tablet

Oral use

Seroxat 20 mg comprimidos con cubierta pelicular

20 mg

Film-coated tablet

Oral use

Paroxetina Alter 20 mg comprimidos con cubierta
pelicular

20 mg

Film-coated tablet

Oral use

C

1
1
8
/
3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

SPAIN
(cont'd)

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

.

.

1
9
5
2
0
0
5

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

Synthon BV
Microweg 22
6545 CM Nijmegen
Nederland

Paroxetina
Rimafar 20 mg
comprimidos
recubiertos EFT

Paroxetina
Synthon

20 mg

Coated tablet

Oral use

20 mg

Film-coated tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
3
9

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

SPAIN
(cont'd)

Tamarang SA
Balmes, 84-4-2a
E-08008 Barcelona

Tamarang SA
Balmes, 84-4-2a
E-08008 Barcelona

UNITED KINGDOM A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89
DK-2000 Frederiksberg

A/S GEA Farmaceutisk Fabrik
Holger Danskes Vej 89
DK-2000 Frederiksberg

Alpharma Ltd
Whiddon Valley
Barnstaple
N.Devon EX32 8NS
United Kingdom

Alpharma Ltd
Whiddon Valley
Barnstaple
N.Devon EX32 8NS
United Kingdom

Apotex Europe Limited
Rowan House
41 London street
Reading; Berkshire
RG1 4PS
United Kingdom

Paroxetina
Tamarang

Paroxetina
Apotex-Farma

Paroxetine
20 mg Tablet

Paroxetine
40 mg Tablet

Paroxetine
20 mg Tablet

Paroxetine
30 mg Tablet

Paroxetine
20 mg Tablet

20 mg

Coated tablet

Oral use

20 mg

Coated tablet

Oral use

20 mg

Tablet

Oral use

40 mg

Tablet

Oral use

20 mg

Tablet

Oral use

30 mg

Tablet

Oral use

20 mg

Tablet

Oral use

C

1
1
8
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

UNITED KINGDOM
(cont'd)

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

.

.

1
9
5
2
0
0
5

GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

Seroxat Tablets 20 mg

20 mg

Tablet

Oral use

Seroxat Tablers 30 mg

30 mg

Tablet

Oral use

Seroxat Liquid 20 mg/10 ml

2 mg/ml

Oral suspension

Oral use

Paroxetine Hydrochloride Tablets 20 mg

20 mg

Tablet

Oral use

Paroxetine Hydrochloride Tablets 30 mg

30 mg

Tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
4
1

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

UNITED KINGDOM
(cont'd)

GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

Lagap Pharmaceuticals Ltd;
Woolmer Way; Bordon;
Hampshire GU35 9QE,
United Kingdom

Medis-Danmark A/S
Havelse Molle 14
DK-3600 Frederikssund

Norton Healthcare Limited
IVAX Quays, Albert Basin, Royal Docks
London E16 2QJ
United Kingdom

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Paroxetine Hydrochloride Liquid 20 mg/10 ml

2 mg/ml

Oral suspension

Oral use

Paroxetine 20 mg Tablet

20 mg

Tablet

Oral use

Paroxetine 20 mg Tablet

20 mg

Tablet

Oral use

Paroxetine Hydrochloride Tablets 20 mg

20 mg

Tablet

Oral use

Paroxetine 20 mg tablets

20 mg

Tablet

Oral use

C

1
1
8
/
4
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

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

AUSTRIA

Pfizer Corp. Austria
Seidengasse 33-35
A-1071 Wien

10 mg/ml

Dectomax 1 %
Injektions-lösung
für Rinder und
Schafe

Pharma-
ceutical form

Solution for
injection

Animal species

Frequency

Recommended dose

Cattle and sheep
No
animals
treatment
producing milk for human
consumption

of

Single dose

200 µg/kg bw

Withdrawal period
(meat and milk)

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

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 produ-
cing milk for human consump-
tion.

Single dose

200 µg/kg bw

FINLAND

Pfizer Oy, Animal Health
Tietokuja 4
FI-00330 Helsinki

Dectomax Vet

10 mg/ml

Solution for
injection

Cattle, Reindeer, Pigs
in
Not permitted
animals producing milk for
human consumption during
lactation

for use

Single dose

Cattle and reindeer:
200 µg/kg bw
Swine:
300 µg/kg bw

Meat:
Cattle: 42 days
Sheep: 35 days
Milk:
Cattle: 60 days
Sheep: 70 days

Meat:
45 days
Milk:
Not to be used later than 60
days prior to expected calving.

Meat:
Cattle and reindeer: 42 days
Swine: 49 days
Milk:
Withdrawal period for milk 60
reindeer and
days for heifers,
animals during the dry period

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
4
3

Member State

Marketing authorisation
holder

Product trade name

Strength

FRANCE

Pfizer
23/25 Ave du docteur
Lannelongue
F-75014 Paris

Dectomax

10 mg/ml

Pharma-
ceutical form

Solution for
injection

Animal species

Frequency

Recommended dose

Withdrawal period
(meat and milk)

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
lactating
milk for human consumption

in
animals producing

for use

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 solu-
tion

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

C

1
1
8
/
4
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5

Member State

Marketing authorisation
holder

Product trade name

Strength

Pharma-
ceutical form

Animal species

Frequency

Recommended dose

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)

Withdrawal period
(meat and milk)

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 NETHER-
LANDS

Pfizer Animal Health BV
PO Box 37
2900 AA Capelle aan den
IJssel
Nederland

(REG

Dectomax
NL 9844)
Prontax (REG NL
9884)

10 mg/ml

Solution for
injection

Non-lactating cattle and sheep,
pigs

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

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

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 solu-
tion 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

SPAIN

Pfizer
Av da. De Europa, 20b
Parque Empresarial La
Moraleja
E-28108 Alcobendas

Dectomax solu-
tion injectable

10 mg/ml

Solution for
injection

Cattle and sheep

Single dose

200 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

Meat
Cattle: 42 days
Sheep: 60 days

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
4
5

Member State

Marketing authorisation
holder

Product trade name

Strength

SWEDEN

Pfizer AB
Box 501
S-183 25 Täby

Dectomax vet

10 mg/ml

Pharma-
ceutical form

Solution for
injection

Animal species

Frequency

Recommended dose

Cattle, sheep, (reindeer)

Not
speci-
fied in the
SPC

Catt1e (and reindeer):
200 µg/kg bw (sc)
Sheep:
200 µg/kg bw (sc or im)

UNITED
KINGDOM

Pfizer Ltd
Pfizer Ltd, Sandwich,
Kent CT13 9NJ,
United Kingdom

Dectomax Inject-
able Solution for
Cattle and Sheep

10mg/ml

Solution for
injection

ICELAND

Pfizer A/S Vestre Gade
DK-18 2650 Hvidovre

Dextomax

1 %

Solution for
injection

Sheep and cattle
Not permitted
in
lactating ewes or cows used to
produce milk
human
consumption

for use

for

Not
speci-
fied in the
SPC

Sheep:
300 µg/kg bw
Cattle:
200 µg/kg bw

Single dose

Cattle esp. bullocks, Not
for
use in lactating cows produ-
cing milk for human consump-
tion, even in the resting period
for use in dairy
Sheep: Not
ewes
for
producing milk
human consumption. Not for
use in pregnant ewes
Pigs

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 preg-
nant 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 consump-
tion

.

.

1
9
5
2
0
0
5

Withdrawal period
(meat and milk)

Meat:
Cattle: 49 days
Sheep: 45 days (im); 60 days
(sc)
Reindeer: 42 days
Milk:
forbidden in lactating
Cattle:
cows, not
to be administered
less than 60 days before calving
forbidden in lactating
Sheep:
to be administered
sheep, not
less
before
days
70
than
lambing

Meat:
Cattle: 70 days
Sheep: 56 days
Milk:
Cattle: Do not use in dry dairy
cows including pregnant heifers
within 60 days before calving

C

1
1
8
/
4
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

Member State

Marketing authorisation
holder

Product trade name

Strength

NORWAY

Pfizer As, Norway
Orion Pharma As Animal
Health
PO Box 52
N-0508 Oslo

Dectomax

10 mg/ml

Pharma-
ceutical form

Solution for
injection

Animal species

Frequency

Recommended dose

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

for

Not
speci-
fied in the
SPC

Cattle and reindeer:
200 µg/kg bw
Sheep:
200 µg/kg bw (sc,
(Nematodirus
300 µg/kg bw (sc, im))
Pigs:
300 µg/kg bw

im),

Withdrawal period
(meat and milk)

Meat:
Cattle and reindeer: 42 days
Sheep: 45 days (im), 60 days
- Nematodirus battus 55
(sc)
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

.

.

1
9
5
2
0
0
5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
1
1
8
/
4
7

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

ANNEX III

Member State

Marketing authorisation
holder

THE NETHERLANDS

Guerbet

GERMANY

Guerbet

Applicant

Invented name

Strength

Pharmaceutical form

Route of administration

Content
(concentration)

Artirem

Artirem

0,0025 mmol/ml

Solution for injection

Intra-articular use

0,0025 mmol/ml

0,0025 mmol/ml

Solution for injection

Intra-articular use

0,0025 mmol/ml

C

1
1
8
/
4
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
9
5
2
0
0
5