Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 August to 15 September 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-10-02
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation

2.10.2002

EN

Official Journal of the European Communities

C 237/5

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 August to 15 September 2002

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

(2002/C 237/03)

— 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

Number of the entry in the
Community Register

Date of
notification

22.8.2002

Xigris

22.8.2002

Neupopeg

22.8.2002

Neulasta

22.8.2002

Evra

30.8.2002

Ambirix

9.9.2002

InductOs

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

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

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

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

EU/1/02/225/001-002

26.8.2002

EU/1/02/228/001

26.8.2002

EU/1/02/227/001

26.8.2002

EU/1/02/223/001-003

26.8.2002

EU/1/02/224/001-005

5.9.2002

EU/1/02/226/001

11.9.2002

— 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

20.8.2002

ReFacto

21.8.2002

Epivir

22.8.2002

Ixense

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

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

EU/1/99/103/001-003

22.8.2002

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

Takeda Europe R & D Centre Ltd
Savanah House
11/12 Charles II Street
London SW1Y 4QU
United Kingdom

EU/1/96/015/001-003

23.8.2002

EU/1/01/181/001-007

27.8.2002

C 237/6

EN

Official Journal of the European Communities

2.10.2002

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

22.8.2002

Fortovase

22.8.2002

NeoRecormon

22.8.2002

Pritor

22.8.2002

Sustiva

22.8.2002

Stocrin

22.8.2002

Visudyne

22.8.2002

PritorPlus

22.8.2002

Combivir

22.8.2002

Aranesp

22.8.2002

Nespo

22.8.2002

Regranex

30.8.2002

Sustiva

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

Novartis Ophtalmics Europe Ltd
Delta House
Southwood Crescent
Southwood
Farnborough
Hants GU 14 0NL
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Dompé Biotec SpA
Via Santa Lucio 4
I-20122 Milan

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

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

EU/1/98/075/001-002

27.8.2002

EU/1/97/031/001-013,
EU/1/97/031/019-044

27.8.2002

EU/1/98/089/001-016

27.8.2002

EU/1/99/110/006-009

27.8.2002

EU/1/99/111/006-009

27.8.2002

EU/1/00/140/001

27.8.2002

EU/1/02/215/001-010

27.8.2002

EU/1/98/058/001-002

27.8.2002

EU/1/01/185/031-032

26.8.2002

EU/1/01/184/031-032

26.8.2002

EU/1/99/101/001

26.8.2002

EU/1/99/110/005

5.9.2002

2.10.2002

EN

Official Journal of the European Communities

C 237/7

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

30.8.2002

Trazec

30.8.2002

Starlix

30.8.2002

Stocrin

9.9.2002

Novonorm

9.9.2002

Zyprexa

9.9.2002

Zenapax

9.9.2002

Plavix

9.9.2002

Iscover

9.9.2002

Zeffix

9.9.2002

DaTSCAN

10.9.2002

Prandin

10.9.2002

Replagal

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

EU/1/01/175/001-021

5.9.2002

EU/1/01/174/001-021

5.9.2002

EU/1/99/111/005

5.9.2002

EU/1/98/076/001-002,
EU/1/98/076/004-009,
EU/1/98/076/011-016,
EU/1/98/076/018-021

11.9.2002

EU/1/96/022/001-018

12.9.2002

EU/1/99/098/001-002

11.9.2002

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

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

11.9.2002

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

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

11.9.2002

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Nycomed Amersham plc
Little Chalfont
Buckinghamshire
HP7 9NA
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

TKT Europe-5S AB
Rinkebyvägen 11B
S-182 36 Danderyd

EU/1/99/114/003

11.9.2002

EU/1/00/135/001-002

11.9.2002

EU/1/00/162/001-018

12.9.2002

EU/1/01/189/002

12.9.2002

C 237/8

EN

Official Journal of the European Communities

2.10.2002

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

10.9.2002

Replagal

10.9.2002

Zyprexa
Velotab

10.9.2002

Exelon

10.9.2002

Olansek

10.9.2002

Viracept

10.9.2002

Invirase

10.9.2002

Norvir

10.9.2002

Zerene

10.9.2002

Sonata

10.9.2002

Tractocile

13.9.2002

Kaletra

13.9.2002

Foscan

TKT Europe-5S AB
Rinkebyvägen 11B
S-182 36 Danderyd

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

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

Eli Lilly UK Ltd
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

Ferring AB
Soldattorpsvägen 5
Box 30 047
S-200 61 Limhamn

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Biolitec Pharma Limited
Research Avenue South
Heriot Watt Research Park
Edinburgh EH14 4AP
United Kingdom

EU/1/01/189/003

12.9.2002

EU/1/99/125/001-004

12.9.2002

EU/1/98/066/001-013

12.9.2002

EU/1/96/021/001-010

12.9.2002

EU/1/97/054/001-005

12.9.2002

EU/1/96/026/001

12.9.2002

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

12.9.2002

EU/1/99/099/001-006

12.9.2002

EU/1/99/102/001-008

12.9.2002

EU/1/99/124/001-002

12.9.2002

EU/1/01/172/001-003

18.9.2002

EU/1/01/197/001-002

19.9.2002

2.10.2002

EN

Official Journal of the European Communities

C 237/9

— Issuing 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

30.8.2002

Dexdomitor

10.9.2002

Nobivac Bb

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/02/033/001

5.9.2002

EU/2/02/034/001

12.9.2002

— 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

11.9.2002

Stronghold

13.9.2002

Oxyglobin

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

Biopure Netherlands BV
Prinses Irenestraat 59
1077-WV Amsterdam
Nederland

EU/2/99/014/001-011

17.9.2002

EU/2/99/015/001

18.9.2002

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.