Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 June 2001 to 15 July 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-07-27
Institutions: European Commission
Subjects: market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation

C 209/6

EN

Official Journal of the European Communities

27.7.2001

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 June 2001 to 15 July 2001

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

(2001/C 209/03)

(cid:151) Issuing of a marketing authorisation (Article 12 of Council 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

3.7.2001

Nonafact

6.7.2001

Mab Campath

9.7.2001

Levviax

9.7.2001

Ketek

11.7.2001

Depocyte

16.7.2001

Ceprotin

Sanquin CLB
Products Division
Plesmanlaan 125
1066 CX Amsterdam
Netherlands

Millennium & ILEX UK Ltd
1 and 3 Frederick Sanger Road
The Surrey Research Park
Guildford
Surrey GU2 7YD
United Kingdom

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

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

SkyePharma plc
105 Piccadilly
London W1V 9FN
United Kingdom

Baxter AG
Industriestra(cid:223)e 67
A-1220 Wien

EU/1/01/186/001-002

5.7.2001

EU/1/01/193/001

10.7.2001

EU/1/01/192/001-004

10.7.2001

EU/1/01/191/001-004

10.7.2001

EU/1/01/187/001

12.7.2001

EU/1/01/190/001-002

17.7.2001

(cid:151) Modification of a marketing authorisation (Article 12 of Council 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

20.6.2001

Sonata

20.6.2001

Zerene

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

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

Wyeth Research (UK) Ltd
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/99/102/001-008

22.6.2001

EU/1/99/099/001-006

22.6.2001

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Official Journal of the European Communities

C 209/7

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

20.6.2001

NovoSeven

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

EU/1/96/006/001-003

22.6.2001

20.6.2001

Gonal F

27.6.2001

Remicade

27.6.2001

Mabthera

27.6.2001

Humalog

29.6.2001

CoAprovel

29.6.2001

Karvezide

2.7.2001

Neurobloc

2.7.2001

Zyprexa

4.7.2001

NeuroBloc

5.7.2001

Caelyx

5.7.2001

Zerit

ARES-Serono (Europe) Ltd
24 Gilbert Street
London W1Y 1RJ
United Kingdom

Centocor BV
Einsteinweg 101
2333 CB Leiden
Netherlands

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

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Netherlands

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

EU/1/95/001/001-021

22.6.2001

EU/1/99/116/001-003

28.6.2001

EU/1/98/067/001-002

28.6.2001

EU/1/96/007/001-018

28.6.2001

EU/1/98/086/001-006

3.7.2001

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

EU/1/98/085/001-006

3.7.2001

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Netherlands

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

SP Europe
Rue de Stalle/Stallestraat, 73
B-1180 Brussels

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

EU/1/00/166/001-003

4.7.2001

EU/1/96/022/016-018

4.7.2001

EU/1/00/166/001-003

6.7.2001

EU/1/96/011/001-004

9.7.2001

EU/1/96/009/001-009

9.7.2001

C 209/8

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Official Journal of the European Communities

27.7.2001

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

11.7.2001

Rilutek

11.7.2001

Epivir

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

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

EU/1/96/010/001

12.7.2001

EU/1/96/015/001-002

12.7.2001

16.7.2001

Infanrix Hexa

16.7.2001

Infanrix Penta

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

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

EU/1/00/152/001-016

17.7.2001

EU/1/00/153/001-008

17.7.2001

16.7.2001

Plavix

16.7.2001

Iscover

16.7.2001

Cellcept

16.7.2001

Cellcept

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

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

17.7.2001

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

EU/1/98/070/001a, 001b,
002a, 002b, 003a, 003b

17.7.2001

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

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

EU/1/96/005/001-006

17.7.2001

EU/1/96/005/001-004,
006

17.7.2001

(cid:151) Modification of a marketing authorisation (Article 34 of Council 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

11.7.2001

Poulflox

Virbac SA
1e avenue 2065 m L.I.D
F-06516 Carros

EU/2/00/023/001-003

12.7.2001

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