EN Official Journal of the European Union C 293/11

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2005 to 31 October 2005

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

(2005/C 293/06)

— Issuing of a marketing authorization (Article 12 of 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 3.10.2005 Vasovist Schering AG, Müllerstrasse 170-178, DE-13342 Berlin EU/1/05/313/001-009 5.10.2005 13.10.2005 Xyrem UCB Pharma Ltd., 208 Bath Road, Slough, Berks, UK-SL1 3WE EU/1/05/312/001 18.10.2005 25.10.2005 Posaconazole SP SP Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73 — BE-1180 Brussel EU/1/05/321/001 27.10.2005 25.10.2005 Aptivus Boehringer Ingelheim International GmbH, Binger Strasse 173 — DE-55216 Ingelheim am Rhein EU/1/05/315/001 27.10.2005 25.10.2005 Xolair Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex, UK-RH12 5AB EU/1/05/319/001-002 27.10.2005 25.10.2005 Kepivance Amgen Europe BV, Minervum 7061, NL-4817 ZK Breda EU/1/05/314/001 27.10.2005 25.10.2005 Noxafil SP Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73 — BE-1180 Brussel EU/1/05/320/001 27.10.2005 25.10.2005 Corlentor Laboratoires Servier, 22, rue Garnier, FR-92200 Neuilly-sur-Seine EU/1/05/317/001-014 27.10.2005 25.10.2005 Procoralan Laboratoires Servier, 22, rue Garnier, FR-92200 Neuilly-sur-Seine EU/1/05/316/001-014 27.10.2005 28.10.2005 Revatio PFIZER Ltd, Ramsgate Road, Sandwich, Kent, UK-CT 13 9NJ EU/1/05/318/001 4.11.2005

— Modification of a marketing authorization (Article 12 of 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 5.10.2005 Mixtard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/02/231/011-013 EU/1/02/231/033-035 10.10.2005 5.10.2005 Actraphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/02/229/011-013 EU/1/02/229/033-035 10.10.2005 5.10.2005 Insulatard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/02/233/005-007 EU/1/02/233/013-015 10.10.2005 5.10.2005 Protaphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/02/234/005-007 EU/1/02/234/013-015 10.10.2005 5.10.2005 Actrapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/02/230/005-007 EU/1/02/230/013-015 10.10.2005 5.10.2005 Prevenar Wyeth-Lederle Vaccines SA, Rue du Bosquet, 15 — BE-1348 Louvain-La-Neuve EU/1/00/167/001-007 7.10.2005 5.10.2005 NovoMix Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/00/142/011-016 10.10.2005 5.10.2005 Fuzeon Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, UK-AL7 3AY EU/1/03/252/001-003 7.10.2005 5.10.2005 Onsenal Pharmacia-Pfizer EEIG, Ramsgate Road, Sanwich, UK-CT13 9NJ EU/1/03/259/001-006 7.10.2005 5.10.2005 NovoMix Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/00/142/017-022 10.10.2005 5.10.2005 Dynastat Pharmacia Europe EEIG, Sandwich, Kent, UK-CT13 9NJ EU/1/02/209/001-008 7.10.2005 6.10.2005 Trisenox Cell Therapeutics (UK) Limited, 100 Pall Mall, London, UK-SW1Y 5HP EU/1/02/204/001 10.10.2005 13.10.2005 Actos Takeda Europe R & D Centre Ltd, Savanah House, 11/12 Charles II Street, London, UK-SW1Y 4QU EU/1/00/150/001-015 18.10.2005 13.10.2005 Glustin Takeda Europe R & D Centre Ltd, Savanah House, 11/12 Charles II Street, London, UK-SW1Y 4QU EU/1/00/151/001-013 18.10.2005 13.10.2005 Procomvax Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, FR-69007 Lyon EU/1/99/104/001 18.10.2005 13.10.2005 Foscan Biolitec pharma Ltd. United Drug, House Magna Drive, IE-Dublin 24 EU/1/01/197/001-002 18.10.2005 19.10.2005 GONAL-f Serono Europe Limited, 56, Marsh Wall, London, UK-E14 9TP EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 21.10.2005 19.10.2005 Tracleer Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London, UK-W4 4AL EU/1/02/220/001-005 21.10.2005 19.10.2005 NeuroBloc Solstice Neurosciences Ltd, Fitzwilton House, Wilton Place, IE-Dublin 2 EU/1/02/166/001-003 21.10.2005 19.10.2005 Velcade Janssen-Cilag International NV, Turnhoutsewe, 30 — BE-2340 Beerse EU/1/04/274/001 21.10.2005 25.10.2005 Paxene Norton Healthcare Limited, Albert Basin, Royal Docks, London, UK-E16 2QJ EU/1/99/113/001-004 27.10.2005 25.10.2005 Pegasys Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, UK-AL7 3AY EU/1/02/221/001-010 27.10.2005 25.10.2005 Orgalutran NV Organon, PO Box 20, Kloosterstraat 6, NL-5340 BH Oss EU/1/00/130/001-002 27.10.2005 25.10.2005 Rebetol Norton Healthcare Limited, Albert Basin, Royal Docks, London, UK-E16 2QJ EU/1/99/107/001-004 27.10.2005 25.10.2005 Telzir Glaxo Group Ltd., Greenford Road, Greenford, Middlesex, UK-UB6 0NN EU/1/04/282/001-002 27.10.2005 25.10.2005 Truvada Gilead Sciences International Limited, Granta Park Abington Cambridge, UK-CB1 6GT EU/1/04/305/001 27.10.2005 25.10.2005 Viread Gilead Sciences International Limited, Cambridge, UK-CB1 6GT EU/1/01/200/001 27.10.2005 25.10.2005 Ovitrelle Serono Europe Limited, 56, Marsh Wall, London, UK-E14 9TP EU/1/01/200/001-007 27.10.2005 25.10.2005 Stocrin Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire, UK-EN11 9BU EU/1/99/111/001-009 27.10.2005 25.10.2005 Cialis Lilly ICOS Limited, St Bride's House — 10 Salisbury Square — London, UK-EC4Y 8EH EU/1/02/237/002-005 27.10.2005 25.10.2005 Refludan Pharmion Limited, Riverside House, Riverside Walk, Windsor, UK-SL4 1NA EU/1/97/035/001-004 27.10.2005 25.10.2005 Sustiva Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge, UK-UD8 1DH EU/1/99/110/001-009 27.10.2005 27.10.2005 Vfend Pfizer Limited, Sandwich, Kent, UK-CT13 9NJ EU/1/02/212/001-026 31.10.2005 27.10.2005 IntronA Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73 — BE-1180 Brussel EU/1/99/127/001-044 2.11.2005 27.10.2005 Rapilysin Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, UK-AL7 3AY EU/1/96/018/001 31.10.2005 27.10.2005 Prevenar Wyeth-Lederle Vaccines SA, Rue du Bosquet, 15 — BE-1348 Louvain-La-Neuve EU/1/00/167/001-007 31.10.2005 27.10.2005 Betaferon Schering AG Pharma, Berlin, DE-13342 Berlin EU/1/95/003/001-004 31.10.2005 27.10.2005 Busilvex Pierre Fabre Médicament, 45 place Abel Gance, FR-92654 Boulogne Billancourt Cedex EU/1/03/254/001 31.10.2005 27.10.2005 Viraferon Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73 — BE-1180 Brussel EU/1/99/128/001-037 2.11.2005 28.10.2005 Abilify Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London, UK-W6 8DW EU/1/04/276/033-035 4.11.2005 28.10.2005 Neupopeg Dompé Biotec SpA, Via San Martino, 12, IT-20122 Milano EU/1/02/228/001-003 4.11.2005 28.10.2005 Aldara 3M Santé, Boulevard de l'Oise, FR-95029 Cergy Pontoise Cedex EU/1/98/080/001 4.11.2005 28.10.2005 Neulasta Amgen Europe BV, Minervum 7061, NL-4817 ZK Breda EU/1/02/227/001-003 4.11.2005

— Suspension of a marketing authorization (Article 18 of Regulation (EEC) No 2309/93)

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 13.10.2005 Bextra Pharmacia-Pfizer EEIG, Sandwich, Kent, UK-CT13 9NJ EU/1/02/239/001-030 19.10.2005

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