Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 June to 15 July 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-07-26
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 178/4

EN

Official Journal of the European Communities

26.7.2002

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

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

(2002/C 178/04)

— 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

20.6.2002

Pegasys

20.6.2002

Tamiflu

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/1/02/221/001-008

24.6.2002

EU/1/02/222/001-002

24.6.2002

— 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

17.6.2002

Prandin

17.6.2002

Humalog

18.6.2002

Teslascan

19.6.2002

Iscover

19.6.2002

Plavix

20.6.2002

Xenical

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

EU/1/00/162/001-018

20.6.2002

EU/1/96/007/001-008
EU/1/96/007/010-019

20.6.2002

EU/1/97/040/001-002

20.6.2002

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

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

21.6.2002

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

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

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

21.6.2002

EU/1/98/071/001-006

24.6.2002

26.7.2002

EN

Official Journal of the European Communities

C 178/5

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

20.6.2002

Remicade

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

20.6.2002

Sustiva

20.6.2002

Ketek

20.6.2002

Levviax

25.6.2002

ReFacto

27.6.2002

Quadramet

28.6.2002

Zerit

28.6.2002

Karvea

28.6.2002

Karvezide

9.7.2002

Lumigan

10.7.2002

Sustiva

10.7.2002

Vistide

10.7.2002

Panretin

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

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

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

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

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

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

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

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

Allergan Pharmaceuticals (Ireland) Ltd
Castlebar Road
Westport
County Mayo
Ireland

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

Pharmacia Enterprises SA
6, Circuit de la Foire Internationale
L-1347 Luxembourg

Ligand Pharmaceuticals UK Ltd
Innovis House
108 High Street
Crawley
West Sussex RH10 1BB
United Kingdom

EU/1/99/116/001-003

27.6.2002

EU/1/99/110/001-005

24.6.2002

EU/1/01/191/001-004

24.6.2002

EU/1/01/192/001-004

24.6.2002

EU/1/99/103/001-003

27.6.2002

EU/1/97/057/001

2.7.2002

EU/1/96/009/001-009

4.7.2002

EU/1/97/049/001-015

4.7.2002

EU/1/98/085/001-010

4.7.2002

EU/1/02/205/002

11.7.2002

EU/1/99/110/001-005

15.7.2002

EU/1/97/037/001

15.7.2002

EU/1/00/149/001

15.7.2002

C 178/6

EN

Official Journal of the European Communities

26.7.2002

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

10.7.2002

Agenerase

11.7.2002

ViraferonPeg

11.7.2002

PegIntron

11.7.2002

Kineret

11.7.2002

Targretin

11.7.2002

Trazec

11.7.2002

Starlix

11.7.2002

Remicade

11.7.2002

Viramune

15.7.2002

Mabthera

15.7.2002

NovoRapid

15.7.2002

HumaSPECT

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Ligand Pharmaceuticals UK Ltd
Innovis House
108 High Street
Crawley
West Sussex RH10 1BB
United Kingdom

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

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

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

KS Biomedix Ltd
1 Occam Court
Surrey Research Park
Guildford
Surrey GU2 7HJ
United Kingdom

EU/1/00/148/004

15.7.2002

EU/1/00/132/031-050

15.7.2002

EU/1/00/131/031-050

15.7.2002

EU/1/02/203/001-003

15.7.2002

EU/1/01/178/001

15.7.2002

EU/1/01/175/001-021

15.7.2002

EU/1/01/174/001-021

15.7.2002

EU/1/99/116/001-003

15.7.2002

EU/1/97/055/001-002

15.7.2002

EU/1/98/067/001-002

17.7.2002

EU/1/99/119/001,
EU/1/99/119/003,
EU/1/99/119/005-011

17.7.2002

EU/1/98/083/001

17.7.2002

26.7.2002

EN

Official Journal of the European Communities

C 178/7

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

15.7.2002

PegIntron

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

EU/1/00/131/001-030

17.7.2002

— 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

9.7.2002

Metacam

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/003-005

11.7.2002

10.7.2002

Quadrisol

10.7.2002

Stronghold

10.7.2002

Metacam

15.7.2002

Clomicalm

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
United Kingdom

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Novartis Tiergesundheit GmbH
Industriestraße 30—34
D-65760 Eschborn

EU/2/97/005/008-009

15.7.2002

EU/2/99/014/001-011

15.7.2002

EU/2/97/004/006

15.7.2002

EU/2/98/007/001-003

17.7.2002

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.