Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 February 2001 to 15 March 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-03-30
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation

C 100/2

EN

Official Journal of the European Communities

30.3.2001

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 February 2001 to 15 March 2001

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

(2001/C 100/02)

(cid:151) 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

16.2.2001

NutropinAq

23.2.2001

Fasturtec

23.2.2001

Metalyse

23.2.2001

Tenecteplase

13.3.2001

Rapamune

Schwarz Pharma AG
Alfred-Nobel-Stra(cid:223)e 10
D-40789 Monheim

Sanofi Synthelabo
174, avenue de France
F-75013 Paris

Boehringer Ingelheim International
GmbH
Binger Stra(cid:223)e 173
D-55216 Ingelheim am Rhein

Boehringer Ingelheim International
GmbH
Binger Stra(cid:223)e 173
D-55216 Ingelheim am Rhein

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

EU/1/00/164/001-002

20.2.2001

EU/1/00/170/001

2.2.2001

EU/1/00/169/001-003

28.2.2001

EU/1/00/168/001-003

28.2.2001

EU/1/01/171/001-005

14.3.2001

(cid:151) 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

16.2.2001

Glustin

16.2.2001

Actos

16.2.2001

Visudyne

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

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

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

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

EU/1/00/151/007-008

20.2.2001

EU/1/00/150/007-008

21.2.2001

EU/1/00/140/001

20.2.2001

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EN

Official Journal of the European Communities

C 100/3

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

22.2.2001

Datscan

22.2.2001

Ziagen

23.2.2001

Patrex

23.2.2001

Refacto

23.2.2001

Remicade

23.2.2001

Tractocile

5.3.2001

Vitravene

5.3.2001

Pylobactell

5.3.2001

Gonal F

Nycomed Amersham plc
Little Chalfont
Buckinhamshire HP7 9NA
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/00/135/002

23.2.2001

EU/1/99/112/001-002

23.2.2001

EU/1/98/078/001-012

28.2.2001

Genetics Institute of Europe BV
Fraunhoferstra(cid:223)e 15
D-82152 Planegg/Martinsried

EU/1/99/103/001-003

28.2.2001

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Ferring AB
Soldattorpsv(cid:228)gen 5
Box 30047
S-200 61 Limhamn

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

Cambridge Export No 2 Limited
Grandview
North Rigton
Leeds LS17 0DW
United Kingdom

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

EU/1/99/116/001-003

28.2.2001

EU/1/99/124/001-002

1.3.2001

EU/1/99/115/001

7.3.2001

EU/1/98/064/001

7.3.2001

EU/1/95/001/017-020

7.3.2001

5.3.2001

Twinrix Paediatric

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

EU/1/97/029/008

8.3.2001

5.3.2001

Novonorm

5.3.2001

Viracept

6.3.2001

Optruma

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

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

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

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

7.3.2001

EU/1/97/054/004

7.3.2001

EU/1/98/074/001-004

8.3.2001

C 100/4

EN

Official Journal of the European Communities

30.3.2001

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

6.3.2001

Evista

6.3.2001

Iscover

6.3.2001

Ferriprox

13.3.2001

Tritanrix Hep B

13.3.2001

Plavix

13.3.2001

Norvir

13.3.2001

Enbrel

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

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

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

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

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

EU/1/98/073/001-004

8.3.2001

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

8.3.2001

EU/1/99/108/001

8.3.2001

EU/1/96/014/001-002

14.3.2001

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

14.3.2001

EU/1/96/016/001-003

16.3.2001

EU/1/99/126/001

14.3.2001

13.3.2001

Quadramet

CIS Bio International
BP 32
F-91192 Gif-sur-Yvette Cedex

EU/1/97/057/001

14.3.2001

(cid:151) 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

13.3.2001

Liprolog

Eli Lilly and Company Limited
Kingsclere Road
Basingstoke
Hants RG21 6XA
United Kingdom

EU/1/97/038/001-003

14.3.2001

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.