Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 April 2003 to 15 May 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-06-03
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 129/18

EN

Official Journal of the European Union

3.6.2003

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 April 2003 to 15 May 2003

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

(2003/C 129/05)

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

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorization

9.4.2003

Protopic

10.4.2003

Protopy

16.4.2003

Zenapax

16.4.2003

Theryttrex

16.4.2003

Kinzalmono

22.4.2003

Renagel

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

Roche Registration Ltd
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

MDS Nordion S.A.
Zoning Industriel
B-6220 Fleurus

Bayer AG
D-51368 Leverkusen

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

Number of
the entry in
the Community Register

Date of
notification

EU/1/02/201/005-006

24.4.2003

EU/1/02/202/005-006

24.4.2003

EU/1/99/098/001-002

23.4.2003

EU/1/02/245/001

23.4.2003

EU/1/98/091/001-014

23.4.2003

EU/1/99/123/008-011

24.4.2003

22.4.2003

Lantus

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/005-011

24.4.2003

22.4.2003

Invanz

22.4.2003

Enbrel

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Wyeth Europa Limited
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/02/216/001

24.4.2003

EU/1/99/126/001-003

24.4.2003

22.4.2003

Kinzalkomb

Bayer AG
D-51368 Leverkusen

EU/1/02/214/001-010

24.4.2003

22.4.2003

Evra

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

EU/1/02/223/001-003

24.4.2003

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

3.6.2003

EN

Official Journal of the European Union

C 129/19

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorization

23.4.2003

Kineret

23.4.2003

Avandia

23.4.2003

Nyracta

23.4.2003

Venvia

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

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

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

Number of
the entry in
the Community Register

Date of
notification

EU/1/02/203/001-004

28.4.2003

EU/1/00/137/001-012

28.4.2003

EU/1/00/139/001-012

28.4.2003

EU/1/00/138/001-012

28.4.2003

8.5.2003

ReFacto

Genetics Institute of Europe BV
Fraunhoferstraße 15
D-82152 Planegg/Martinsried

EU/1/99/103/001-004

13.5.2003

8.5.2003

Crixivan

12.5.2003

Nonafact

12.5.2003

Refludan

12.5.2003

Ferriprox

12.5.2003

Iscover

14.5.2003

Comtan

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Sanquin
Plesmanlaan 125
1066 CX Amsterdam
Nederland

Schering AG
Müllerstraße 170—178
D-13342 Berlin

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

EU/1/96/024/001-010

13.5.2003

EU/1/01/186/001-002

14.5.2003

EU/1/97/035/001-004

15.5.2003

EU/1/99/108/001

14.5.2003

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

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

EU/1/98/070/001a-004b

14.5.2003

EU/1/98/081/001-004

16.5.2003

C 129/20

EN

Official Journal of the European Union

3.6.2003

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorization

14.5.2003

Viraferonpeg

14.5.2003

Pegintron

14.5.2003

Epivir

15.5.2003

Taluvian

15.5.2003

Uprima

15.5.2003

Ixense

15.5.2003

Optison

15.5.2003

ReFacto

15.5.2003

Synagis

15.5.2003

Remicade

15.5.2003

Remicade

15.5.2003

Remicade

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Abbott SpA
Campoverde di Aprilia
I-04010 Latina

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Takeda Europe R&D Centre Ltd
Savanah House
11/12 Charles II Street
London SW1Y 4QU
United Kingdom

Amersham Health AS
Nycoveien 1-2
PO Box 4220 Nydalen
0401 Oslo
Norway

Wyeth Europa Ltd
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Number of
the entry in
the Community Register

Date of
notification

EU/1/00/132/031-050

16.5.2003

EU/1/00/131/031-050

16.5.2003

EU/1/96/015/001-003

16.5.2003

EU/1/01/182/001-010

19.5.2003

EU/1/01/180/001-010

19.5.2003

EU/1/01/181/001-007

19.5.2003

EU/1/98/065/001-002

19.5.2003

EU/1/99/103/001-004

19.5.2003

EU/1/99/117/001-002

19.5.2003

EU/1/99/116/001-003

19.5.2003

EU/1/99/116/001-003

19.5.2003

EU/1/99/116/001-003

19.5.2003

3.6.2003

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Official Journal of the European Union

C 129/21

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

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

23.4.2003

Ibaflin

8.5.2003

Locatim

12.5.2003

Eurifel FelV

12.5.2003

Metacam

12.5.2003

Metacam

12.5.2003

Oxyglobin

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Biokema Anstalt
Aeulestraße 38
9490 Vaduz
Fürstentum Liechtenstein

Merial
17, rue Bourgelat
F-69002 Lyon

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Biopure Netherlands BV
Prinses Irenestraat 59
1077 WV Amsterdam
Nederland

Number of
the entry in
the Community Register

Date of
notification

EU/2/00/022/001a-008

24.4.2003

EU/2/99/011/001

13.5.2003

EU/2/00/019/001-003

14.5.2003

EU/2/97/004/007-008

14.5.2003

EU/2/97/004/007-008

14.5.2003

EU/2/99/015/001

14.5.2003

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.