Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 February 2004 to 15 March 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-03-26
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 77/2

EN

Official Journal of the European Union

26.3.2004

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 February 2004 to 15 March 2004

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

(2004/C 77/02)

— 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

23.2.2004

Ibandronic
Acid Roche

23.2.2004

Bonviva

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

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

EU/1/03/266/001-002

26.2.2004

EU/1/03/265/001-002

26.2.2004

2.3.2004

Advate

Baxter AG
Industriestraße 67
A-1221 Wien

EU/1/03/271/001-004

4.3.2004

2.3.2004

Reyataz

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

EU/1/03/267/001-007

4.3.2004

10.3.2004

Faslodex

10.3.2004

Cholestagel

AstraZeneca UK Limited
Alderley Park
Macclesfield
Cheshire SK10 4TG
United Kingdom

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

EU/1/03/269/001

12.3.2004

EU/1/03/268/001-003

12.3.2004

— 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

20.2.2004

Foscan

Biolitec pharma limited
Research Avenue South
Heriot-Watt
Research Park
Edinburgh EH14 4AP
United Kingdom

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

EU/1/01/197/001-002

24.2.2004

26.3.2004

EN

Official Journal of the European Union

C 77/3

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

23.2.2004

Gonal-f

23.2.2004

NeoRecormon

23.2.2004

Vfend

Serono Europe Limited
56, Marsh Wall
London E14 9TP
United Kingdom

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/95/001/033-035

26.2.2004

EU/1/97/031/045-046

26.2.2004

EU/1/02/212/026

26.2.2004

23.2.2004

Integrilin

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

EU/1/99/109/001-002

26.2.2004

23.2.2004

Rebif

23.2.2004

Ceprotin

23.2.2004

Xigris

23.2.2004

InductOs

Serono Europe Ltd
56 Marsh Wall
London E14 9TP
United Kingdom

Baxter AG
Industriestraße 67
A-1220 Wien

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

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

EU/1/98/063/001-006

26.2.2004

EU/1/01/190/001-002

26.2.2004

EU/1/02/225/001-002

26.2.2004

EU/1/02/226/001

26.2.2004

2.3.2004

Levitra

Bayer AG
D-51368 Leverkusen

EU/1/03/248/001-012

4.3.2004

2.3.2004

Aprovel

2.3.2004

Karvezide

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

Bristol-Myers
Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

EU/1/97/046/0016-030

4.3.2004

EU/1/98/085/011-020

4.3.2004

2.3.2004

Optisulin

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/001-008

11.3.2004

C 77/4

EN

Official Journal of the European Union

26.3.2004

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

2.3.2004

CoAprovel

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

EU/1/98/086/011-020

4.3.2004

2.3.2004

Karvea

2.3.2004

Protopic

2.3.2004

Humalog

2.3.2004

Xenical

Bristol-Myers
Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

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

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

EU/1/97/049/016-030

4.3.2004

EU/1/02/201/001-006

4.3.2004

EU/1/96/007/001-008
EU/1/96/007/010-028

4.3.2004

EU/1/98/071/001-006

4.3.2004

2.3.2004

Vivanza

Bayer AG
D-51368 Leverkusen

EU/1/03/249/001-012

4.3.2004

2.3.2004

Hepsera

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/03/251/001

8.3.2004

4.3.2004

Protopic

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

EU/1/02/201/001-006

8.3.2004

4.3.2004

Vaniqa

4.3.2004

Prometax

4.3.2004

Exelon

4.3.2004

Exelon

Shire Pharmaceutical Contracts Ltd
Hampshire
International Business Park
Chineham
Basingstoke
Hampshire RG24 8EP
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

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

EU/1/01/173/001-003

8.3.2004

EU/1/98/092/001-017

8.3.2004

EU/1/98/066/014-017

8.3.2004

EU/1/98/066/018

8.3.2004

26.3.2004

EN

Official Journal of the European Union

C 77/5

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

4.3.2004

Prometax

5.3.2004

Emadine

8.3.2004

DepoCyte

8.3.2004

Paxene

8.3.2004

Remicade

9.3.2004

Remicade

10.3.2004

Temodal

10.3.2004

Invanz

10.3.2004

Agenerase

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

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

SkyePharma plc
105 Piccadilly
London W1V 9FN
United Kingdom

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

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/98/092/018

8.3.2004

EU/1/98/095/001-004

9.3.2004

EU/1/01/187/001

10.3.2004

EU/1/99/113/001-004

10.3.2004

EU/1/99/116/001-003

10.3.2004

EU/1/99/116/001-003

11.3.2004

EU/1/98/096/001-008

12.3.2004

EU/1/02/216/001-002

12.3.2004

EU/1/00/148/001-004

12.3.2004

— 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

2.3.2004

Valdyn

Pharmacia Europe EEIG
Hillbottom Road
High Wycombe
Buckinghamshire HP12 4PX
United Kingdom

EU/1/02/242/001-024

5.3.2004

C 77/6

EN

Official Journal of the European Union

26.3.2004

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

2.3.2004

Xapit

Pharmacia Europe EEIG
Hillbottom Road
High Wycombe
Buckinghamshire HP12 4PX
United Kingdom

EU/1/02/208/001-008

5.3.2004

2.3.2004

Tikosyn

8.3.2004

Cotronak

10.3.2004

Allex

10.3.2004

Opulis

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

EU/1/99/121/001-015

4.3.2004

EU/1/99/106/001-003

10.3.2004

EU/1/00/159/001-034

12.3.2004

EU/1/00/158/001-034

12.3.2004

— 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

2.3.2004

Novem

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/2/04/042/001-004

4.3.2004

— 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

23.2.2004

Ibaflin

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/022/013-017

27.2.2004

2.3.2004

Dexdomitor

Orion Corporation
Orionintie 1
FIN-02200 Espoo

EU/2/02/033/001

4.3.2004

2.3.2004

Stronghold

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/2/99/014/001-011

4.3.2004

26.3.2004

EN

Official Journal of the European Union

C 77/7

— Withdrawal of a marketing authorisation (Article 34 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

2.3.2004

Pulsaflox

Virbac SA
1e Avenue 2065
m L.I.D.
F-06516 Carros

EU/2/00/023/001-003

4.3.2004

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 authorizations in respect of medicinal products
from 15 February 2004 to 15 March 2004

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

— Issuing, maintenance or modification of a national marketing authorisation

(2004/C 77/03)

Date of the
decision

Name of the medicinal product

Holder of the marketing
authorization

Member State concerned

Date of
notification

20.2.2004

Gatifloxacin

See Annex I

See Annex I

23.2.2004

1.12.2003

Calcichew-D3 mite

See Annex II

See Annex II

5.12.2003

23.2.2004

Cardiostad

See Annex III

See Annex III

26.2.2004

23.2.2004

Lisinopril Biochemie

See Annex IV

See Annex IV

26.2.2004

2.3.2004

Pravachol

See Annex V

See Annex V

3.3.2004

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.