Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 March 2001 to 15 April 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-04-27
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation

C 127/2

EN

Official Journal of the European Communities

27.4.2001

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

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

(2001/C 127/02)

(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

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

EU/1/01/173/001-03

22.3.2001

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Bracco International BV
Strawinskylaan 3051
1077 ZX Amsterdam
Nederland

Ligand Pharmaceuticals UK Ltd
2 Kings Hill Avenue
West Malling
Kent ME19 4AQ
United Kingdom

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

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

EU/1/01/172/001-03

22.3.2001

EU/1/01/176/001-03

22.3.2001

EU/1/01/177/001-02

29.3.2001

EU/1/01/178/001

2.4.2001

EU/1/01/175/001-21

5.4.2001

EU/1/01/174/001-21

5.4.2001

20.3.2001

Vaniqa

20.3.2001

Kaletra

20.3.2001

Zometa

26.3.2001

SonoVue

29.3.2001

Targretin

3.4.2001

Trazec

3.4.2001

Starlix

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

27.4.2001

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Official Journal of the European Communities

C 127/3

(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

20.3.2001

NeoRecormon

20.3.2001

Hycamtin

20.3.2001

Infergen

20.3.2001

Visudyne

20.3.2001

Cetrotide

20.3.2001

Exelon

20.3.2001

Zerene

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

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

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

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

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

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

Wyeth Research (UK) Limited
Huntercombe Lane
South
Taplow, Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/97/031/001-044

21.3.2001

EU/1/98/092/001-013

21.3.2001

EU/1/98/087/001-003

21.3.2001

EU/1/00/140/001

22.3.2001

EU/1/99/100/001-002

22.3.2001

EU/1/98/066/001-013

22.3.2001

EU/1/99/099/001-006

22.3.2001

20.3.2001

Fareston

Orion Corporation
Orionintie 1
FIN-02200 Espoo

EU/1/96/004/001-002

22.3.2001

20.3.2001

Sonata

20.3.2001

Rebif

Wyeth Research (UK) Limited
Huntercombe Lane
South
Taplow, Maidenhead
Berkshire SL6 0PH
United Kingdom

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

EU/1/99/102/001-008

22.3.2001

EU/1/98/063/001-006

29.3.2001

C 127/4

EN

Official Journal of the European Communities

27.4.2001

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

20.3.2001

Twinrix Adult

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

EU/1/96/020/001-009

22.3.2001

20.3.2001

Rapilysin

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

EU/1/96/018/001

22.3.2001

20.3.2001

Infanrix Hep B

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

EU/1/97/048/001-012

22.3.2001

20.3.2001

Twinrix Paediatric

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

EU/1/97/029/001-007

23.3.2001

20.3.2001

Avandia

20.3.2001

Nyracta

20.3.2001

Venvia

20.3.2001

Prometax

20.3.2001

Myocet

21.3.2001

Myocet

26.3.2001

Simulect

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

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

The Liposome Company Ltd
3 Shortlands
Hammersmith
International Center
London W6 8EH
United Kingdom

EU/1/00/137/001-012

22.3.2001

EU/1/00/139/001-012

22.3.2001

EU/1/00/138/001-012

22.3.2001

EU/1/98/092/001-013

22.3.2001

EU/1/00/141/001

23.3.2001

Elan Pharma International Limited
WIL House
Shannon Business Park
Shannon, County Clare,
Ireland

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

EU/1/00/141/001

3.4.2001

EU/1/98/084/001

29.3.2001

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C 127/5

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

26.3.2001

Teslascan

26.3.2001

Ziagen

26.3.2001

Rebetol

26.3.2001

ViraferonPeg

26.3.2001

Cotronak

26.3.2001

Pegintron

3.4.2001

Betaferon

10.4.2001

Puregon

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Schering Plough Europe
73, rue de Stalle
B-1180 Bruxelles

Schering Plough Europe
73, rue de Stalle
B-1180 Bruxelles

Schering Plough Europe
73, rue de Stalle
B-1180 Bruxelles

Schering Plough Europe
73, rue de Stalle
B-1180 Bruxelles

Schering AG
D-13342 Berlin

NV Organon
Kloosterstraat 6
Postbus 20
5340 BH Oss
Nederland

EU/1/97/040/001-002

29.3.2001

EU/1/99/112/001-002

29.3.2001

EU/1/99/107/001-003

28.3.2001

EU/1/00/132/001-030

28.3.2001

EU/1/99/106/001-003

28.3.2001

EU/1/00/131/001-030

28.3.2001

EU/1/95/003/001-004

5.4.2001

EU/1/96/008/001-039

12.4.2001

(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

20.3.2001

Turvel

Roerig Farmaceutici Italiana SpA
SS 156 (cid:151) Km 50
I-04010 Borgo San Michele (Latina)

EU/1/98/061/001-012

23.3.2001

20.3.2001

Turvel IV

Roerig Farmaceutici Italiana SpA
SS 156 (cid:151) Km 50
I-04010 Borgo San Michele (Latina)

EU/1/98/062/001-003

23.3.2001

C 127/6

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Official Journal of the European Communities

27.4.2001

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

20.3.2001

Trovan

20.3.2001

Trovan IV

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/98/059/001-012

23.3.2001

EU/1/98/060/001-003

29.3.2001

(cid:151) Issuing 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

13.3.2001

Zubrin

26.3.2001

Eurican Herpes 205

Schering-Plough Limited
Schering-Plough House
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
United Kingdom

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/00/028/001-008

14.3.2001

EU/2/01/029/001-002

29.3.2001

(cid:151) 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

10.4.2001

Oxiglobin

10.4.2001

Porcilis Porcoli

Biopure Netherlands BV
Prinses Irenestraat 59
1077 WV Amsterdam
Nederland

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

EU/2/99/015/001

18.4.2001

EU/2/96/001/001-002

18.4.2001

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.