Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October to 15 November 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-11-29
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

29.11.2002

EN

Official Journal of the European Communities

C 297/3

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 October to 15 November 2002

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

(2002/C 297/03)

— 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

12.11.2002 Cialis

13.11.2002

Somavert

Lilly ICOS Limited
25 New Street Square
London EC4A 3LN
United Kingdom

Pharmacia Enterprises SA
6, Circuit de la Foire Internationale
BP 2507
L-1025 Luxembourg

Number of
the entry in
the Community register

Date of
notification

EU/1/02/237/001-004

14.11.2002

EU/1/02/240/001-003

15.11.2002

— 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

17.10.2002

Epivir

17.10.2002

Tracleer

17.10.2002

Prevenar

17.10.2002

Trizivir

17.10.2002 DaTSCAN

17.10.2002

Prometax

17.10.2002 Crixivan

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

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

Actelion Registration Ltd
90 Fetter Lane (ground floor)
London EC4A 7JP
United Kingdom

Wyeth-Lederle Vaccines SA
Rue du Bosquet 15
B-1348 Louvain-La-Neuve

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Amersham plc
Little Chalfont
Buckinhamshire HP7 9NA
United Kingdom

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

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

Number of
the entry in
the Community register

Date of
notification

EU/1/96/015/002

21.10.2002

EU/1/02/220/001-005

21.10.2002

EU/1/00/167/001-002
EU/1/00/167/005

21.10.2002

EU/1/00/156/001-003

21.10.2002

EU/1/00/135/001-002

21.10.2002

EU/1/98/092/001-013

21.10.2002

EU/1/96/024/001-010

21.10.2002

C 297/4

EN

Official Journal of the European Communities

29.11.2002

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

17.10.2002

Targretin

18.10.2002 Nyracta

18.10.2002 Venvia

18.10.2002 Avandia

18.10.2002 Zyprexa

18.10.2002 Cellcept

22.10.2002

INOmax

23.10.2002 Kineret

23.10.2002

Lumigan

23.10.2002 HBVAXPRO

24.10.2002

Twinrix Adult

24.10.2002

Twinrix Paediatric

24.10.2002

Infanrix hexa

24.10.2002

Patrex

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

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

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

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

AGA AB
S-181 81 Lidingö

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland

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

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

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

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Number of
the entry in
the Community register

Date of
notification

EU/1/01/178/001

22.10.2002

EU/1/00/139/001-012

22.10.2002

EU/1/00/138/001-012

22.10.2002

EU/1/00/137/001-012

22.10.2002

EU/1/96/022/016-018

22.10.2002

EU/1/96/005/001-006

22.10.2002

EU/1/01/194/002

24.10.2002

EU/1/02/203/001-004

29.10.2002

EU/1/02/205/001-002

29.10.2002

EU/1/01/183/001-018

29.10.2002

EU/1/96/020/001-009

29.10.2002

EU/1/97/029/001-009

29.10.2002

EU/1/00/152/001-018

29.10.2002

EU/1/98/078/001-012

29.10.2002

29.11.2002

EN

Official Journal of the European Communities

C 297/5

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

24.10.2002 Viagra

24.10.2002 Agenerase

28.10.2002

Puregon

28.10.2002 DaTSCAN

28.10.2002 Ziagen

29.10.2002 Aprovel

29.10.2002 Karvea

29.10.2002 Helicobacter test

INFAI

7.11.2002

Evista

7.11.2002

Norvir

7.11.2002

Protopy

7.11.2002

Optruma

7.11.2002

MabCampath

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Organon NV
PO Box 20
5340 BH Oss
Nederland

Nycomed Amersham plc
Little Chalfont
Buckinhamshire HP7 9NA
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

für biomedizinische Analytic

INFAI
Institut
und NMR Imaging GmbH
Universitätsstraße 142
D-44799 Bochum

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

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

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

Number of
the entry in
the Community register

Date of
notification

EU/1/98/077/001-012

29.10.2002

EU/1/00/148/001-004

29.10.2002

EU/1/96/008/001-039

30.10.2002

EU/1/00/135/001-002

30.10.2002

EU/1/99/112/001-002

30.10.2002

EU/1/97/046/001-015

5.11.2002

EU/1/97/049/001-015

5.11.2002

EU/1/97/045/001-002

5.11.2002

EU/1/98/073/001-004

11.11.2002

EU/1/96/016/001
EU/1/96/016/003

11.11.2002

EU/1/02/202/001-004

11.11.2002

EU/1/98/074/001-004

11.11.2002

EU/1/01/193/001

12.11.2002

C 297/6

EN

Official Journal of the European Communities

29.11.2002

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

Dr. Karl Thomae GmbH
Birkendorfferstraße 65
D-88397 Biberach/Riss

Number of
the entry in
the Community register

Date of
notification

EU/1/97/052/001-006
EU/1/97/052/009-010

13.11.2002

8.11.2002

Daquiran

8.11.2002

Mirapexin

8.11.2002

Sifrol

8.11.2002

Protopic

12.11.2002 Osigraft

12.11.2002 Kaletra

12.11.2002

Epivir

12.11.2002 Zerit

12.11.2002 Azopt

12.11.2002

Invanz

12.11.2002

Travatan

13.11.2002 Humalog

13.11.2002 Kaletra

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

EU/1/97/051/001-006
EU/1/97/051/009-012

13.11.2002

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

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

Howmedica International S. de R.L.
Division of Stryker Corporation
Raheen Industrial Estate
Raheen Limerick
Ireland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

13.11.2002

EU/1/02/201/001-004

13.11.2002

EU/1/01/179/001

14.11.2002

EU/1/01/172/001-003

14.11.2002

EU/1/96/015/001

14.11.2002

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

EU/1/96/009/010-017

14.11.2002

Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UK
United Kingdom

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

Alcon Laboratories (UK) Ltd
Boundary Way
Hemel Hempstead
Herts HP2 7UK
United Kingdom

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/00/129/001-003

14.11.2002

EU/1/02/216/001

14.11.2002

EU/1/01/199/001-002

14.11.2002

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

15.11.2002

EU/1/01/172/001-003

15.11.2002

29.11.2002

EN

Official Journal of the European Communities

C 297/7

— Withdrawal of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93)

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

24.10.2002 Hepacare

8.11.2002

Novomix

Medeva Pharma Limited
Regent Park
Kingston Road
Leatherhead
Surrey KT22 7PQ
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Number of
the entry in
the Community register

Date of
notification

EU/1/00/136/001-002

30.10.2002

EU/1/00/142/003
EU/1/00/142/006

13.11.2002

— 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

EU/2/99/013/001-002

29.10.2002

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

24.10.2002 Halocur

28.10.2002 Metacam

5.11.2002

Pruban

14.11.2002

Ibraxion

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/001
EU/2/97/004/007-008

30.10.2002

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/00/024/001

7.11.2002

EU/2/99/017/001-006

18.11.2002

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.