Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April 2001 to 15 May 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-05-31
Institutions: European Commission
Subjects: marketing, marketing standard, medicinal product

C 158/2

EN

Official Journal of the European Communities

31.5.2001

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 April 2001 to 15 May 2001

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

(2001/C 158/02)

(cid:151) Issuing 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

27.4.2001

HBVaxpro

Aventis Pasteur MSD SNC
8, rue Jonas-Salk
F-69007 Lyon

EU/1/01/183/001-017

4.5.2001

(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

23.4.2001

Renagel

23.4.2001

NovoRapid

23.4.2001

CoAprovel

23.4.2001

Karvea

23.4.2001

Vitravene

23.4.2001

Karvezide

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

Genzyme BV
Gooimeer 10
Naarden 1411 DD
Nederland

Novo Nordisk A/S
DK-2880 Bagsv(cid:230)rd

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

Bristol-Myers Squibb Pharma EEIG
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

Novartis Ophtalmics Europe Ltd
Delta House
Southwood Crescent
Southwood
Farnborough
Hants GU14 0NL
United Kingdom

Bristol-Myers Squibb Pharma EEIG
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

EU/1/99/123/005-010

25.4.2001

EU/1/99/119/001-010

25.4.2001

EU/1/98/086/001-006

25.4.2001

EU/1/97/049/001-009

25.4.2001

EU/1/99/115/001

25.4.2001

EU/1/98/085/001-006

25.4.2001

31.5.2001

EN

Official Journal of the European Communities

C 158/3

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

23.4.2001

Aprovel

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

EU/1/97/046/001-009

25.4.2001

23.4.2001

Benefix

Genetics Institute of Europe BV
Fraunhoferstra(cid:223)e 15
D-82152 Planegg/Martinsried

EU/1/97/047/001-003

25.4.2001

23.4.2001

Zeffix

23.4.2001

Bondronat

23.4.2001

Enbrel

27.4.2001

Caelyx

27.4.2001

Cellecept

27.4.2001

Keppra

3.5.2001

Taxotere

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

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

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

UCB SA
AllØe de la recherche, 60
B-1070 Bruxelles

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

EU/1/99/114/001-003

25.4.2001

EU/1/96/012/005

25.4.2001

EU/1/99/126/001

25.4.2001

EU/1/96/011/001-004

30.4.2001

EU/1/96/005/001-006

30.4.2001

EU/1/00/146/001-026

2.5.2001

EU/1/95/002/001-002

7.5.2001

3.5.2001

Tritanrix HepB

SmithKline Beecham Biologicals SA
Rue de l’Institut, 89
B-1330 Rixensart

EU/1/96/014/0001-002

7.5.2001

3.5.2001

Cellcept

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

EU/1/96/005/001-006

8.5.2001

C 158/4

EN

Official Journal of the European Communities

31.5.2001

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

3.5.2001

Novoseven

Novo Nordisk A/S
DK-2880 Bagsv(cid:230)rd

EU/1/96/006/001-003

7.5.2001

3.5.2001

Xenical

3.5.2001

Cystagon

3.5.2001

Twinrix Enfant

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

Orphan Europe SARL
Immeuble (cid:145)Le Guillaumet(cid:146)
60, avenue du PrØsident-Wilson
F-92046 Paris La DØfense

SmithKline Beecham Biologicals SA
Rue de l’Institut, 89
B-1330 Rixensart

EU/1/98/071/001-006

8.5.2001

EU/1/97/039/001-004

7.5.2001

EU/1/97/029/001-007

17.5.2001

(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

23.4.2001

Metacam

Boehringer Ingelheim
Vetmedica GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/007-008

25.4.2001

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.