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.