Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 December 2001 to 15 January 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-01-25
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 23/2

EN

Official Journal of the European Communities

25.1.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 December 2001 to 15 January 2002

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

(2002/C 23/02)

(cid:151) 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

17.12.2001

Infanrix Hep B

17.12.2001

Twinrix Adult

17.12.2001

Norvir

17.12.2001 Quadramet

17.12.2001

Sifrol

17.12.2001

Enbrel

17.12.2001

Exelon

17.12.2001

Plavix

18.12.2001

Twinrix Enfant

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

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

CIS bio international
BP 32
F-91192 Gif-sur-Yvette
Cedex (CEA/CEN
Route Nationale 306, F-Saclay)

Boehringer Ingelheim International
GmbH
Binger Stra(cid:223)e 173
D-55216 Ingelheim am Rhein

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

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

Sanofi Pharma Bristol-Myers
Squibb SNC
174, avenue de France
F-75013 Paris

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

EU/1/97/048/001-012

19.12.2001

EU/1/96/020/001-009

19.12.2001

EU/1/96/016/003

21.12.2001

EU/1/97/057/001

20.12.2001

EU/1/97/050/001-006,
009-012

20.12.2001

EU/1/99/126/001

20.12.2001

EU/1/98/066/001-013

20.12.2001

EU/1/98/069/001a,
001b, 002a, 002b, 003a,
003b

20.12.2001

EU/1/97/029/001-008

20.12.2001

25.1.2002

EN

Official Journal of the European Communities

C 23/3

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

18.12.2001

Infanrix Penta

19.12.2001

Infanrix Hexa

27.12.2001

CEA-Scan

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

Immunomedics Europe
Haarlemmerstraat 30
2181 HC Hillegom
Nederland

EU/1/00/153/001-008

20.12.2001

EU/1/00/152/001-016

24.12.2001

EU/1/96/023/001

27.12.2001

(cid:151) Suspension of a marketing authorisation (Article 18 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

17.12.2001

Tasmar

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

EU/1/97/044/001-006

20.12.2001

(cid:151) 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

17.12.2001

Zubrin

18.12.2001 Oxyglobin

Schering-Plough Limited
Schering-Plough House
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
United Kingdom

Biopure Netherlands BV
Prinses Irenestraat 59
1077-WV Amsterdam
Nederland

EU/2/00/028/001-008

19.12.2001

EU/2/99/015/001

20.12.2001

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