You are on page 1of 3

C 244/2 EN Official Journal of the European Communities 25.8.

2000

Summary of Community decisions on marketing authorisations in respect of medicinal products


for the period from 15 June 2000 to 15 July 2000

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

(2000/C 244/02)

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

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

11.7.2000 Venvia SmithKline Beecham plc EU/1/00/138/001-012 26.7.2000


New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

11.7.2000 Nyracta SmithKline Beecham plc EU/1/00/139/001-012 26.7.2000


New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

13.7.2000 Myocet The Liposome Company Ltd EU/1/00/141/001 26.7.2000


3 Shortlands
Hammersmith
International Center
London W 8EH
United Kingdom

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


Accepted

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

11.7.2000 Simulect Novartis Europharm Ltd EU/1/98/084/001 20.7.2000


Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

11.7.2000 Procomvax Aventis Pasteur MSD SNC EU/1/99/104/001 20.7.2000


8, rue Jonas-Salk
F-69007 Lyon

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


25.8.2000 EN Official Journal of the European Communities C 244/3

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

11.7.2000 Zyprexa Eli Lilly EU/1/96/022/005-006 20.7.2000


Nederland BV
Krijtwal 17-23
3432 ZT Nieuwegein
Nederland

11.7.2000 Helicobacter INFAI EU/1/97/045/001 20.7.2000


test INFAI Institut für biomedizinische Analytic
und NMR Imaging GmbH
Universitätsstraße 142
D-44799 Bochum

11.7.2000 Puregon NV Organon EU/1/96/008/038-039 20.7.2000


Postbus 20
5340 BH Oss
Nederland

13.7.2000 Plavix Sanofi Pharma Bristol-Myers Squibb EU/1/98/069/001 20.7.2000


SNC a-001b-002a-002b-003a-003b
32-34, rue Marbeuf
F-75008 Paris

13.7.2000 Iscover Bristol-Myers Squibb Pharma EEIG EU/1/98/070/001 20.7.2000


Swakeleys House a-001b-002a-002b-003a-003b
Milton Road
Ickenham UB10 8PU
United Kingdom

13.7.2000 Vistide Pharmacia & Upjohn SA EU/1/97/037/001 20.7.2000


52, route d’Esch
L-1470 Luxembourg

13.7.2000 Viracept Roche Registration Limited EU/1/98/054/001-003 20.7.2000


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

13.7.2000 Telmisartan Boehringer Ingelheim International EU/1/98/091/001-008 20.7.2000


Boehringer GmbH
Ingelheim Binger Straße 173
Pharma KG D-55216 Ingelheim am Rhein
C 244/4 EN Official Journal of the European Communities 25.8.2000

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


Accepted

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

13.7.2000 Metacam Boehringer Ingelheim Vetmedica EU/2/97/004/001 20.7.2000


GmbH
D-55216 Ingelheim am Rhein

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


for the period from 15 June 2000 to 15 July 2000

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1))


(2000/C 244/03)

— Modification of a national marketing authorisation

Date of the Names of the medicinal Holders of the Member State Date of
decision products marketing authorization concerned notification

27.6.2000 Leucomax/Mielogen/SCH39300 See Annex See Annex 28.6.2000

(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).