Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 March to 15 April 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-04-26
Institutions: European Commission
Subjects: market approval, medicinal product

C 101/2

EN

Official Journal of the European Communities

26.4.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 March to 15 April 2002

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

(2002/C 101/02)

— 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

18.3.2002

Dynepo

19.3.2002

Vfend

21.3.2002

Arixtra

21.3.2002

Quixidar

22.3.2002

Dynastat

22.3.2002

Rayzon

22.3.2002

Xapit

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

EU/1/02/211/001-009

21.3.2002

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Sanofi-Synthelabo
174, avenue de France
F-75013 Paris

Organon NV
Postbus 20
Kloosterstraat 6
5340 EB Oss
Nederland

Pharmacia Europe EEIG
Hillbottom Road
High Wycombe
Buckinghamshire
HP12 4PX
United Kingdom

Pharmacia Europe EEIG
Hillbottom Road
High Wycombe
Buckinghamshire
HP12 4PX
United Kingdom

Pharmacia Europe EEIG
Hillbottom Road
High Wycombe
Buckinghamshire
HP12 4PX
United Kingdom

EU/1/02/212/001-025

21.3.2002

EU/1/02/206/001-004

25.3.2002

EU/1/02/207/001-004

25.3.2002

EU/1/02/209/001-008

26.3.2002

EU/1/02/210/001-008

26.3.2002

EU/1/02/208/001-008

26.3.2002

— 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

21.3.2002

Mabthera

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

EU/1/98/067/001-002

25.3.2002

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

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Official Journal of the European Communities

C 101/3

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

21.3.2002

Xeloda

21.3.2002

Sustiva

21.3.2002

Myocet

21.3.2002

Humalog

21.3.2002

Crixivan

22.3.2002

Arava

22.3.2002

Rilutek

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

Bristol-Myers Squibb
Pharma (UK) Limited
Wedgwood Way
Stevenage
Hertfordshire SG1 4QN
United Kingdom

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

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

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

EU/1/00/163/001-002

25.3.2002

EU/1/99/110/001-005

25.3.2002

EU/1/00/141/001

25.3.2002

EU/1/96/007/002-004,
011, 015

25.3.2002

EU/1/96/024/001-010

25.3.2002

Aventis Pharma Deutschland GmbH
Brüningstraße 50
D-65926 Frankfurt am Main

EU/1/99/118/001-010

3.4.2002

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

EU/1/96/010/001

27.3.2002

22.3.2002

Insuman

Aventis Pharma Deutschland GmbH
Brüningstraße 50
D-65926 Frankfurt am Main

EU/1/97/030/028-084

2.4.2002

26.3.2002

Kaletra

26.3.2002

Ketek

26.3.2002

Keppra

26.3.2002

Starlix

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

UCB SA
Allée de la recherche 60
B-1070 Bruxelles

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

EU/1/01/172/001-003

2.4.2002

EU/1/01/191/001-004

10.4.2002

EU/1/00/146/001-026

2.4.2002

EU/1/01/174/001-021

2.4.2002

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EN

Official Journal of the European Communities

26.4.2002

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

26.3.2002

Cerezyme

26.3.2002

Kaletra

27.3.2002

Levviax

27.3.2002

Destara

27.3.2002

Rapilysin

2.4.2002

NovoRapid

2.4.2002

Tenecteplase

2.4.2002

Metalyse

2.4.2002

Zeffix

2.4.2002

Infergen

2.4.2002

IntronA

2.4.2002

Viraferon

2.4.2002

Rebif

2.4.2002

Sustiva

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Serono Europe Ltd
56 Marsh Wall
London E14 9TP
United Kingdom

EU/1/97/053/001-005

2.4.2002

EU/1/01/172/001-003

2.4.2002

EU/1/01/192/001-004

4.4.2002

EU/1/96/013/001-004

4.4.2002

EU/1/96/018/011

4.4.2002

EU/1/99/119/011

4.4.2002

EU/1/00/168/001-003

4.4.2002

EU/1/00/169/001-003

4.4.2002

EU/1/99/114/001-003

4.4.2002

EU/1/98/087/001-003

4.4.2002

EU/1/99/127/001-044

4.4.2002

EU/1/99/128/001-037

4.4.2002

EU/1/98/063/001-006

4.4.2002

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

EU/1/99/110/001-005

4.4.2002

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C 101/5

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

2.4.2002

Taluvian

2.4.2002

INOmax

2.4.2002

Simulect

10.4.2002

Aprovel

10.4.2002

Vitravene

10.4.2002

Replagal

10.4.2002

Karvea

10.4.2002

Karvezide

11.4.2002

Aprovel

11.4.2002

Temodal

11.4.2002

Coaprovel

11.4.2002

Twinrix Enfant

11.4.2002

Twinrix Adulte

Abbott SpA
Campoverde di Aprilia
I-04010 Latina

AGA AB
S-181 81 Lidingö

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

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

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

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

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

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

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

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

EU/1/01/182/001-010

4.4.2002

EU/1/01/194/001

4.4.2002

EU/1/98/084/001

4.4.2002

EU/1/97/046/001-012

12.4.2002

EU/1/99/115/001

12.4.2002

EU/1/01/189/001

12.4.2002

EU/1/97/049/001-012

12.4.2002

EU/1/98/085/001-008

12.4.2002

EU/1/97/046/001-015

15.4.2002

EU/1/98/096/001-008

15.4.2002

EU/1/98/086/001-008

15.4.2002

EU/1/97/029/001-007

15.4.2002

EU/1/96/020/001-009

15.4.2002

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Official Journal of the European Communities

26.4.2002

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

12.4.2002

Rapamune

12.4.2002

Rapamune

12.4.2002

Myocet

12.4.2002

Uprima

12.4.2002

Stocrin

12.4.2002

Rebetol

12.4.2002

Cotronak

12.4.2002

Aerius

12.4.2002

Allex

12.4.2002

Opulis

12.4.2002

Azomyr

12.4.2002

Neoclarityn

12.4.2002

Actos

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

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

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

EU/1/01/171/007-008

16.4.2002

EU/1/01/171/001-006

16.4.2002

EU/1/00/141/001

17.4.2002

EU/1/01/180/001-010

16.4.2002

EU/1/99/111/001-005

16.4.2002

EU/1/99/107/001-003

16.4.2002

EU/1/99/106/001-003

16.4.2002

EU/1/00/160/001-013

16.4.2002

EU/1/00/159/001-013

16.4.2002

EU/1/00/158/001-013

16.4.2002

EU/1/00/157/001-013

16.4.2002

EU/1/00/161/001-013

16.4.2002

EU/1/00/150/001-010

16.4.2002

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Official Journal of the European Communities

C 101/7

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

12.4.2002

Glustin

12.4.2002

Foscan

12.4.2002

Karvea

12.4.2002

Ferriprox

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

Scotia Pharmaceuticals Limited
Scotia House
Castle Business Park
Stirling FK9 4TZ
United Kingdom

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

Apotex Europe Ltd
22 Clarendon Road
Leeds LS2 9NZ
United Kingdom

EU/1/00/151/001-008

16.4.2002

EU/1/01/197/001-002

16.4.2002

EU/1/97/049/001-015

16.4.2002

EU/1/99/108/001

16.4.2002

— 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

Number of the entry in the
Community Register

Date of
notification

2.4.2002

Vitrasert

Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165—173
D-13581 Berlin (Spandau)

EU/1/97/034/001

4.4.2002

— 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

12.4.2002

Fevaxyn pentofel

Fort Dodge Laboratories Ireland
Finisklin Industrial Estate
Sligo
Ireland

EU/2/96/002/001-003

16.4.2002

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.