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26.1.

2001 EN Official Journal of the European Communities C 26/5

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 December 2000 to 15 January 2001

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

(2001/C 26/04)

— Issuing of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93): Accepted

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorisation
decision product Community Register notification

28.12.2000 Trizivir Glaxo Group Ltd EU/1/00/156/001-003 2.1.2001
Greenford
Middlesex UB6 0NN
United Kingdom

15.1.2001 Allex Schering Plough Europe EU/1/00/159/001-013 18.1.2001
Rue de Stalle 73
B-1180 Brussels

15.1.2001 Opulis Schering Plough Europe EU/1/00/158/001-013 18.1.2001
Rue de Stalle 73
B-1180 Brussels

15.1.2001 Aerius Schering Plough Europe EU/1/00/160/001-013 18.1.2001
Rue de Stalle 73
B-1180 Brussels

15.1.2001 Neoclarityn Schering Plough Europe EU/1/00/161/001-013 18.1.2001
Rue de Stalle 73
B-1180 Brussels

15.1.2001 Azomyr Schering Plough Europe EU/1/00/157/001-013 18.1.2001
Rue de Stalle 73
B-1180 Brussels

— Modification of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93):
Accepted

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorisation
decision product Community Register notification

18.12.2000 Forcaltonin Unigene UK Limited EU/1/98/093/001-002 19.12.2000
63 High Road
Bushey Heath
Herts WD2 1EE
United Kingdom

18.12.2000 Patrex Roerig Farmaceutici SpA EU/1/98/078/001-012 19.12.2000
Strada Statale, 156, km 50
I-04010 Borgo S. Michele (Latina)

18.12.2000 Triacelluvax Chiron SpA EU/1/98/088/001-009 19.12.2000
Via Fiorentina, 1
I-53100 Sienne

(1) OJ L 214, 24.8.1993, p. 1.
C 26/6 EN Official Journal of the European Communities 26.1.2001

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorisation
decision product Community Register notification

18.12.2000 Prometax Novartis Europharm Limited EU/1/98/092/001-002 19.12.2000
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

18.12.2000 Prometax Novartis Europharm Limited EU/1/98/092/013 19.12.2000
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

27.12.2000 Vitrasert Dr. Gerhard Mann EU/1/97/034/001 29.12.2000
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165—173
D-13581 Berlin (Spandau)

27.12.2000 Refacto Genetics Institute of Europe BV EU/1/99/103/001-003 29.12.2000
Fraunhoferstraße 15
D-82152 Planegg/Martinsried

27.12.2000 Invirase Roche Registration Ltd EU/1/96/026/001 2.1.2001
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

27.12.2000 Zyprexa Velotab Eli Lilly Nederland BV EU/1/99/125/001-004 2.1.2001
Krijtwal 17-23
3432 ZT Nieuwegein
Netherlands

27.12.2000 Zyprexa Eli Lilly Nederland BV EU/1/96/022/012-015 2.1.2001
Krijtwal 17-23
3432 ZT Nieuwegein
Netherlands

27.12.2000 Combivir Glaxo Group Ltd EU/1/98/058/001-002 28.12.2000
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

28.12.2000 Avonex Biogen France SA EU/1/97/033/001 2.1.2001
55, avenue des Champs-Pierreux
F-92012 Nanterre Cedex

28.12.2000 Taxotere Aventis Pharma SA EU/1/95/002/001-002 2.1.2001
20, avenue Raymond-Aron
F-92165 Antony Cedex

28.12.2000 Olansek Eli Lilly UK Ltd EU/1/96/021/001-010 2.1.2001
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

28.12.2000 Zyprexa Eli Lilly Nederland BV EU/1/96/022/001-011 2.1.2001
Krijtwal 17-23
3432 ZT Nieuwegein
Netherlands
26.1.2001 EN Official Journal of the European Communities C 26/7

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorisation
decision product Community Register notification

29.12.2000 Rilutek Aventis Pharma SA EU/1/96/010/001 8.1.2001
20, avenue Raymond-Aron
F-92165 Antony Cedex

29.12.2000 Gonal F Ares-Serono (Europe) EU/1/95/001/001-020 2.1.2001
24 Gilbert Street
London W1Y 1RJ
United Kingdom

15.1.2001 Plavix Sanofi Pharma Bristol-Myers Squibb SNC EU/1/98/069/001a-001b- 17.1.2001
174, avenue de France 002a-002b-003a-003b
F-75013 Paris

15.1.2001 Iscover Bristol-Myers Squibb Pharma EEIG EU/1/98/070/001a-001b- 17.1.2001
Swakeleys House 002a-002b-003a-003b
Milton Road
Ickenham UB10 8PU
United Kingdom

15.1.2001 Karvea Bristol-Myers Squibb Pharma EEIG EU/1/97/049/001-009 17.1.2001
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

15.1.2001 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC EU/1/97/046/001-009 17.1.2001
174, avenue de France
F-75013 Paris

15.1.2001 Puregon NV Organon EU/1/96/008/001-039 18.1.2001
Kloosterstraat 6
Postbus 20
5340 BH Oss
Netherlands

15.1.2001 Ammonaps Orphan Europe EU/1/99/120/001-004 17.1.2001
Immeuble ‘Le Guillaumet’
F-92046 Paris-La DØfense

— Modification of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93):
Accepted

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorisation
decision product Community Register notification

20.12.2000 Ibaflin Intervet International BV (NL) EU/2/00/022/001a,001b, 22.12.2000
Wim de Körverstraat 35 002a,002b,003a,003b,
5831 AN Boxmeer 004a,004b,005,006,007,
Netherlands 008

28.12.2000 Fevaxyn Pentofel Fort Dodge Laboratories Ireland EU/2/96/002/001-003 3.1.2001
Finisklin Industrial Estate
Sligo
Ireland
C 26/8 EN Official Journal of the European Communities 26.1.2001

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorisation
decision product Community Register notification

28.12.2000 Halocur Intervet International BV (NL) EU/2/99/013/001-002 2.1.2001
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands

— Suspension of a marketing authorisation (Article 40 of Regulation (EEC) No 2309/93)

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorisation
decision product Community Register notification

20.12.2000 Econor Novartis Animal Health Austria GmbH EU/2/98/010/001-024 22.12.2000
Biochemiestraße 10
A-6250 Kundl

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.

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 December 2000 to 15 January 2001

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1) or Article 22 of Directive 81/851/EEC (2))

(2001/C 26/05)

— Issuing of a national marketing authorisation

Date of the Name(s) of the medicinal Date of
Holder(s) of the marketing authorisation Member State concerned
decision product notification

27.12.2000 KØtoprofŁne See Annex See Annex 28.12.2000
Ethypharm LP

(1) OJ L 147, 9.6.1975, p. 13; as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(2) OJ L 317, 6.11.1981, p. 1; as last amended by Directive 93/40/EEC (OJ L 214, 24.8.1993, p. 31).