Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 July 2002 to 15 August 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-08-30
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

30.8.2002

EN

Official Journal of the European Communities

C 206/3

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 July 2002 to 15 August 2002

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2002/C 206/03)

— Modification of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93):

Accepted

Date of
the decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

16.7.2002

ViraferonPeg

18.7.2002

Keppra

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

UCB SA
allée de la recherche 60
B-1070 Bruxelles

EU/1/00/132/001-030

18.7.2002

EU/1/00/146/001-026

22.7.2002

18.7.2002

Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-010

22.7.2002

18.7.2002

Fareston

Orion Corporation Orionintie 1
FIN-02200 Espoo

EU/1/96/004/001-004

23.7.2002

18.7.2002

Allex

18.7.2002

Azomyr

18.7.2002

Opulis

18.7.2002

Neoclarityn

18.7.2002

Aerius

19.7.2002

ViraferonPeg

19.7.2002

PegIntron

19.7.2002

Axura

19.7.2002

Zometa

22.7.2002

Ketek

(1) OJ L 214, 24.8.1993, p. 1.

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
rue de Stalle 73
B-1180 Bruxelles

EU/1/00/159/001-034

22.7.2002

EU/1/00/157/001-034

22.7.2002

EU/1/00/158/001-034

22.7.2002

EU/1/00/161/001-034

22.7.2002

EU/1/00/160/001-034

22.7.2002

EU/1/00/132/031-050

23.7.2002

EU/1/00/131/031-050

23.7.2002

Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100—104
D-60318 Frankfurt am Main

EU/1/02/218/001-006

23.7.2002

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
United Kingdom

Aventis Pharma SA
20, avenue Raymond-Aron
F-92160 Antony

EU/1/01/176/001-003

23.7.2002

EU/1/01/191/001-004

24.7.2002

C 206/4

EN

Official Journal of the European Communities

30.8.2002

Date of
the decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

22.7.2002

Levviax

22.7.2002

Daquiran

26.7.2002

Renagel

30.7.2002

Nespo

30.7.2002

Hycamtin

30.7.2002

Aranesp

2.8.2002

Revasc

5.8.2002

MicardisPlus

6.8.2002

Avonex

Aventis Pharma SA
20, avenue Raymond-Aron
F-92160 Antony

Dr. Karl Thomae GmbH
Birkendorfferstraße 65
D-88397 Biberach/Riss

Genzyme Europe BV
Gooimeer 10
Naarden 1411 DD
Nederland

Dompé Biotec SpA
Via Santa Lucio 4
I-20122 Milan

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

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Aventis Pharma SA
20, avenue Raymond-Aron
F-92165 Antony Cedex

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Biogen France SA
«Le Capitole»
55, avenue des Champs Pierreux
F-92012 Nanterre Cedex

EU/1/01/192/001-004

24.7.2002

EU/1/97/052/001-006,
009-010

24.7.2002

EU/1/99/123/001-011

30.7.2002

EU/1/01/184/001-030

1.8.2002

EU/1/96/027/001-003-
005

1.8.2002

EU/1/01/185/001-030

1.8.2002

EU/1/97/043/001-002

6.8.2002

EU/1/02/213/001-010

8.8.2002

EU/1/97/033/001-002

8.8.2002

9.8.2002

Optisulin

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/008

13.8.2002

— Withdrawal of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93)

Date of
the decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

18.7.2002

Hycamtin

30.7.2002

Vitravene

EU/1/96/027/002

22.7.2002

EU/1/99/115/001

1.8.2002

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

Novartis Ophtalmics Europe Ltd
Delta House
Southwood Crescent
Southwood
Farnborough
Hampshire GU 14 0NL
United Kingdom

30.8.2002

EN

Official Journal of the European Communities

C 206/5

— Issuing 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

Number of the entry in the
Community Register

Date of
notification

9.8.2002

Gallivac HVT IBD

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/02/032/001

13.8.2002

— 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

Number of the entry in the
Community Register

Date of
notification

9.8.2002

Metacam

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/006

13.8.2002

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.

Non-opposition to a notified concentration

(Case COMP/M.2838 — P & O Stena Line (Holding) Limited)

(2002/C 206/04)

(Text with EEA relevance)

On 7 August 2002 the Commission decided not to oppose the above notified concentration and to declare
it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation
(EEC) No 4064/89. The full text of the decision is only available in English and will be made public after it
is cleared of any business secrets it may contain. It will be available:

— as a paper version through the sales offices of the Office for Official Publications of the European

Communities (see list on the last page),

— in electronic form in the ‘CEN’ version of the CELEX database, under document No 302M2838. CELEX

is the computerised documentation system of European Community law.

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