24.12.2004   

EN

Official Journal of the European Union

C 320/23


Summary of Community decisions on marketing authorisations in respect of medicinal products for the period 15 November 2004 to 15 December 2004

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

(2004/C 320/13)

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

16.11.2004

Xagrid

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

EU/1/04/295/001

18.11.2004

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

16.11.2004

Tamiflu

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

EU/1/02/222/001

18.11.2004

17.11.2004

Trizivir

Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom

EU/1/00/156/001-003

19.11.2004

17.11.2004

Targretin

Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom

EU/1/01/178/001

19.11.2004

25.11.2004

Bextra

Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/239/001-024

29.11.2004

25.11.2004

ReFacto

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

EU/1/99/103/001-004

29.11.2004

30.11.2004

Xigris

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

EU/1/02/225/001-002

2.12.2004

30.11.2004

Tracleer

Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220/001-005

2.12.2004

30.11.2004

Cialis

Lilly ICOS Limited, St Bride's House, 10 Salisbury Square, London, EC4Y 8EH, United Kingdom

EU/1/02/237/001

EU/1/02/237/005

2.12.2004

1.12.2004

Micardis

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein

EU/1/98/090/001-014

3.12.2004

6.12.2004

Integrilin

Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom

Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles, Stallestraat 73, B-1180 Brussel

EU/1/99/109/001-002

8.12.2004

6.12.2004

Epivir

Glaxo Group Ltd, Greenford Road, Greenford, Middlesex, UB6 0NN, United Kingdom

EU/1/96/015/001-005

8.12.2004

6.12.2004

Dynastat

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/209/001-008

8.12.2004

6.12.2004

Sustiva

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

EU/1/99/110/001-009

8.12.2004

6.12.2004

NutropinAq

IPSEN Limited, 190 Bath Road, Slough, Berkshire, SLI 3XE, United Kingdom

EU/1/00/164/001-005

8.12.2004

6.12.2004

Strocrin

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

EU/1/99/111/001-009

8.12.2004

6.12.2004

Dynastat

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/209/001-008

8.12.2004

6.12.2004

Panretin

Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom

EU/1/00/149/001

8.12.2004

6.12.2004

Arava

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/99/118/001-010

8.12.2004

6.12.2004

Viread

Gilead Sciences International Limited, Cambridge, CB1 6GT United Kingdom

EU/1/01/200/001

8.12.2004

6.12.2004

Rayzon

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-008

8.12.2004

6.12.2004

Rayzon 6m

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-008

8.12.2004

7.12.2004

Kinzalmono

Bayer AG, D-51368 Leverkusen

EU/1/98/091/001-014

9.12.2004

7.12.2004

Micardis

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein

EU/1/98/090/001-014

10.12.2004

7.12.2004

Pritor

Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom

EU/1/98/089/001-016

9.12.2004

Withdrawal of a marketing authorization (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

8.12.2004

Venvia

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

EU/1/00/138/001-012

10.12.2004

7.12.2004

Nyracta

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

EU/1/00/139/001-012

9.12.2004

Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

25.11.2004

Nobivac Bb

Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/02/034/001

29.11.2004

25.11.2004

Halocur

Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/99/013/001-002

29.11.2004

7.12.2004

Stronghold

Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/2/99/014/001-012

10.12.2004

7.12.2004

Oxyglobin

Biopure Netherlands BV, Prinses Irenestraat 59, 1077 WV Amsterdam, Nederland

EU/2/99/015/001

9.12.2004


(1)  OJ L 214, 24.8.1993, p. 1.