Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 November 2000 to 15 December 2000 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-01-05
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical legislation

5.1.2001

EN

Official Journal of the European Communities

C 2/3

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 November 2000 to 15 December 2000

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

(2001/C 2/04)

(cid:151) Issuing of a marketing authorisation (Article 12 of Council 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

29.11.2000 Neospect

29.11.2000

Luveris

Nycomed Imaging AS
Nycoveien 1-2
PO Box 4220
Torshov
N-0401 Oslo

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

EU/1/00/154/001-002

4.12.2000

EU/1/00/155/001-006

30.11.2000

(cid:151) Modification of a marketing authorisation (Article 12 of Council 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

14.11.2000

Aprovel

14.11.2000

Paxene

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

EU/1/97/046/001-009

16.11.2000

Norton Healthcare Limited
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

EU/1/99/113/001-002

16.11.2000

16.11.2000

Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-009

20.11.2000

16.11.2000

Viracept

16.11.2000

Crixivan

16.11.2000

Viraferon Peg

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

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

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

EU/1/97/054/001-003

20.11.2000

EU/1/96/024/010

20.11.2000

EU/1/00/132/001-030

20.11.2000

C 2/4

EN

Official Journal of the European Communities

5.1.2001

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

16.11.2000 Daquiran

Dr. Karl Thomae GmbH
D-88397 Biberach/Ri(cid:223)

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

20.11.2000

16.11.2000

Remicade

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

16.11.2000

Viramune

16.11.2000

Karvea

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

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

EU/1/99/116/001-003

20.11.2000

EU/1/97/055/001-002

20.11.2000

EU/1/97/049/001-009

20.11.2000

16.11.2000

Pegintron

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

EU/1/00/131/001-030

17.11.2000

16.11.2000

Karvezide

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

EU/1/98/085/001-006

20.11.2000

16.11.2000

Coaprovel

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

EU/1/98/086/001-006

27.11.2000

16.11.2000

Azopt

29.11.2000

Cystagon

29.11.2000

Infergen

29.11.2000 Optison

1.12.2000

Exelon

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

Orphan Europe SARL
Immeuble (cid:145)Le Guillaumet(cid:146)
60, avenue du PrØsident-Wilson
F-92046 Paris-la-DØfense

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

Mallinckrodt Medical GmbH
Josef-Dietzgen-Stra(cid:223)e 1-3
D-53773 Hennef

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

EU/1/00/129/003

17.11.2000

EU/1/97/039/001-004

4.12.2000

EU/1/98/087/001-003

30.11.2000

EU/1/98/065/001-002

30.11.2000

EU/1/98/066/001-012

4.12.2000

5.1.2001

EN

Official Journal of the European Communities

C 2/5

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

1.12.2000

Exelon

1.12.2000

Ferriprox

1.12.2000

Simulect

7.12.2000

Viagra

8.12.2000

Puregon

8.12.2000

Rebif

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

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

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Organon NV
PO Box 20
5340 BH Oss
Nederland

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

EU/1/98/066/013

4.12.2000

EU/1/99/108/001

4.12.2000

EU/1/98/084/001

4.12.2000

EU/1/98/077/001-012

15.12.2000

EU/1/98/008/001-039

11.12.2000

EU/1/98/063/001-006

11.12.2000

(cid:151) Withdrawal of a marketing authorisation (Article 12 of Council 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

29.11.2000 Novomix 30

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

EU/1/00/142/001-002

4.12.2000

(cid:151) Issuing of a marketing authorisation (Article 34 of Council 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

13.11.2000

Porcilis Art DF

16.11.2000

Poulflox

16.11.2000

Pruban

Intervet International BV
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Nederland

Virbac SA
1re avenue 2065 m LID
F-06516 Carros

Intervet International BV
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/026/001-002

20.11.2000

EU/2/00/023/001-003

20.11.2000

EU/2/00/024/001

20.11.2000

C 2/6

EN

Official Journal of the European Communities

5.1.2001

(cid:151) Modification of a marketing authorisation (Article 34 of Council 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

16.11.2000

Stronghold

16.11.2000 Quadrisol

16.11.2000 Doxirobe Gel

29.11.2000

Ibaflin

29.11.2000

Pocilis Pesti

7.12.2000

Metacam

7.12.2000

Dicural

7.12.2000

Nobi-vac Porcoli

8.12.2000

Clomicalm

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

Intervet International BV
35 Wim de K(cid:246)rverstraat
5831 AN Boxmeer
Nederland

Pharmacia & Upjohn NV
Rijksweg 12
B-2870 Puurs

Intervet International BV
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Nederland

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

Intervet International BV
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Nederland

Novartis Tiergesundheit GmbH
Industriestra(cid:223)e 30-34
D-65760 Eschborn

EU/2/99/014/001-011

20.11.2000

EU/2/97/005/001-007

20.11.2000

EU/2/99/012/001-002

20.11.2000

EU/2/00/022/001-004

4.12.2000

EU/2/99/010/001-006

1.12.2000

EU/2/97/004/001

8.12.2000

EU/2/97/003/004-015

8.12.2000

EU/2/96/001/001-002

11.12.2000

EU/2/98/007/001-003

11.12.2000

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.