Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October 2003 to 15 November 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2003-11-28
Institutions: European Commission
Subjects: market approval, medicinal product

C 285/6

EN

Official Journal of the European Union

28.11.2003

— Modification of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal
product

Holder of the
marketing
authorisation

17.10.2003 Gallivac HVT IBD

17.10.2003

EurifelFeLV

17.10.2003

ProteqFlu

17.10.2003

Proteqflu-Te

20.10.2003 Neocolipor

20.10.2003

Eurican Herpes 205

Merial
29, avenue Tony Garnier
F-69007 Lyon

Merial
29, avenue Tony Garnier
F-69007 Lyon

Merial
Laboratoire Porte des Alpes
rue de l'Aviation
F-69800 Saint-Priest

Merial
Laboratoire Porte des Alpes
rue de l'Aviation
F-69800 Saint-Priest

Merial
29, avenue Tony Garnier
F-69007 Lyon

Merial
29, avenue Tony Garnier
F-69007 Lyon

Number of the
entry in the
Community
Register

Date of
notification

EU/2/02/032/001

23.10.2003

EU/2/00/019/001-003

23.10.2003

EU/2/03/037/001-004

23.10.2003

EU/2/03/038/001-004

23.10.2003

EU/2/98/008/001-004

23.10.2003

EU/2/01/029/001-003

23.10.2003

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom.

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 October 2003 to 15 November 2003

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

— Issuing, maintenance or modification of a national marketing authorisation

(2003/C 285/03)

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorisation

Member State concerned

Date of
notification

17.10.2003

Isotretinoin

See Annex I

See Annex I

22.10.2003

17.10.2003

Isotretinoin
(Roaccutane)

See Annex II

See Annex II

21.10.2003

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

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

ANNEX I

.

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Member State

Applicant/Marketing
Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package-sizes

BELGIUM

DENMARK

GERMANY

FINLAND

FRANCE

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Lurantal

10 mg

Soft capsules

Oral use

Blister

Lurantal

20 mg

Soft capsules

Oral use

Blister

Scheritonin

10 mg

Soft capsules

Oral use

Blister

Scheritonin

20 mg

Soft capsules

Oral use

Blister

Lurantal

10 mg

Soft capsules

Oral use

Blister

Lurantal

20 mg

Soft capsules

Oral use

Blister

Lurantal

10 mg

Soft capsules

Oral use

Blister

Lurantal

20 mg

Soft capsules

Oral use

Blister

Scheritonin

10 mg

Soft capsules

Oral use

Blister

Scheritonin

20 mg

Soft capsules

Oral use

Blister

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

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Member State

Applicant/Marketing
Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package-sizes

GREECE

IRELAND

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Scheritonin

10 mg

Soft capsules

Oral use

Blister

Scheritonin

20 mg

Soft capsules

Oral use

Blister

Scheritonin

5 mg

Soft capsules

Oral use

Blister

Scheritonin

10 mg

Soft capsules

Oral use

Blister

Scheritonin

20 mg

Soft capsules

Oral use

Blister

ITALY

LUXEMBOURG

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Rexidal

20 mg

Soft capsules

Oral use

Blister

Lurantal

10 mg

Soft capsules

Oral use

Blister

Lurantal

20 mg

Soft capsules

Oral use

Blister

THE NETHERLANDS Schering Health Care Ltd

Lurantal

10 mg

Soft capsules

Oral use

Blister

The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Lurantal

20 mg

Soft capsules

Oral use

Blister

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

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Member State

Applicant/Marketing
Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package-sizes

AUSTRIA

PORTUGAL

SPAIN

UNITED
KINGDOM

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex RH15 9NE
United Kingdom

.

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8
1
1
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3

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Lurantal

10 mg

Soft capsules

Oral use

Blister

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

Lurantal

20 mg

Soft capsules

Oral use

Blister

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

E
N

Scheritonin

10 mg

Soft capsules

Oral use

Blister

Scheritonin

20 mg

Soft capsules

Oral use

Blister

Trivane

10 mg

Soft capsules

Oral use

Blister

Trivane

20 mg

Soft capsules

Oral use

Blister

Isotretinoïne

5 mg

Soft capsules

Oral use

Blister

Isotretinoïne

10 mg

Soft capsules

Oral use

Blister

Isotretinoïne

20 mg

Soft capsules

Oral use

Blister

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

20, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 & 180

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

ANNEX II

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package-size

AUSTRIA

Roche Austria GmbH
Engelhorngasse 3
A-1211 Wien

BELGIUM

NV Roche SA
Dantestraat 75
B-1070 Brussel

Roaccutane ‘Roche’

10 mg

Soft capsules

Oral

Blister

30, 100

Roaccutane ‘Roche’

20 mg

Soft capsules

Oral

Blister

30, 100

Roaccutane

10 mg

Soft capsules

Oral

Blister

30, 60

Roaccutane

20 mg

Soft capsules

Oral

Blister

30, 60

DENMARK

Hoffmann-La Roche & Co
CH-4002 Basel

Roaccutan

10 mg

Soft capsules

Oral

Blister

30, 50, 100

Roaccutan

20 mg

Soft capsules

Oral

Blister

30, 50, 100

FINLAND

Roche Oy
Sinimäentie 10 A
FIN-02630 Espoo/Esbo

Roaccutan

10 mg

Soft capsules

Oral

Roaccutan

20 mg

Soft capsules

Oral

Blister

Blister

100

100

FRANCE

Roche
52, boulevard du Parc
F-92521 Neuilly-sur-Seine
Cedex

Roaccutane

5 mg

Soft capsules

Oral

Blister

30, 60

Roaccutane

10 mg

Soft capsules

Oral

Blister

30, 60

Roaccutane

20 mg

Soft capsules

Oral

Blister

30, 60

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Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package-size

GERMANY

Hoffmann-La Roche AG
Emil-Barell-Straße 1
D-79639 Grenzach-Wyhlen

Roaccutan

10 mg

Soft capsules

Oral

Roaccutan

20 mg

Soft capsules

Oral

GREECE

Roche Hellas SA
Αλαµάνας 4 & ∆ελφών
GR-151 25 Μαρούσι

Roaccutan

10 mg

Soft capsules

Oral

Roaccutan

20 mg

Soft capsules

Oral

IRELAND

Roche Products Limited
PO Box 8
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Roaccutane

5 mg

Soft capsules

Oral

Roaccutane

20 mg

Soft capsules

Oral

ITALY

Roche SpA
Piazza Durante
I-20131 Milano

Roaccutan

2,5 mg

Soft capsules

Oral

Roaccutan

10 mg

Soft capsules

Oral

Roaccutan

20 mg

Soft capsules

Oral

LUXEMBOURG

NV Roche SA
Dantestraat 75
B-1070 Brussel

Roaccutane

10 mg

Soft capsules

Oral

Roaccutane

20 mg

Soft capsules

Oral

PORTUGAL

Roche Farmacêutica
Química Lda.
Estrada Nacional 249-1
P-2720-413 Amadora

Roaccutan

10 mg

Soft capsules

Oral

Roaccutan

20 mg

Soft capsules

Oral

Blister

Blister

Blister

Blister

50

50

30

30

Blister
Amber glass bottles

56, 60
100

Blister
Amber glass bottles

56, 60
100

Blister

Blister

Blister

Blister

Blister

Blister

Blister

30

30

30

30, 60

30, 60

20, 50

20, 50

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Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package-size

SPAIN

Roche Farma SA
Josefa Valcárcel, 42
E-28027 Madrid

Roacutan

10 mg

Soft capsules

Oral

Roacutan

20 mg

Soft capsules

Oral

THE NETHERLANDS Roche Nederland BV

Roaccutane

10 mg

Soft capsules

Oral

Nijverheidsweg 38
3641 RR Mijdrecht
Nederland

UNITED
KINGDOM

Roche Products Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Roaccutane

20 mg

Soft capsules

Oral

Roaccutane

5 mg

Soft capsules

Oral

Roaccutane

20 mg

Soft capsules

Oral

ICELAND

F. Hoffmann La-Roche Ltd
Postfach
CH-4002 Basel

Roaccutan

10 mg

Soft capsules

Oral

Roaccutan

20 mg

Soft capsules

Oral

Blister

Blister

Blister

Blister

50

50

30

30

Blister
Amber glass bottles

56, 60
100

Blister
Amber glass bottles

56, 60
100

Blister

Blister

50

50

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