PT Jornal Oficial da União Europeia C 293/11

Lista das decisões comunitárias no domínio da autorização de colocação de medicamentos no mercado de 1 de Outubro de 2005 a 31 de Outubro de 2005

[Publicada ao abrigo do artigo 12.o ou do artigo 34.o do Regulamento (CEE) n.o 2309/93 do Conselho (1)]

(2005/C 293/06)

— Concessão da autorização de colocação no mercado [artigo 12.o do Regulamento (CEE) n.o 2309/93 do Conselho]: Aceitação

Data da decisão Nome do medicamento Titular da autorização de colocação no mercado N.o de inscrição no registo comunitário Data de notificação 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

— Alteração de uma autorização de colocação no mercado ]artigo 12.o do Regulamento (CEE) n.o 2309/93 do Conselho]: Aceitação

Data da decisão Nome do medicamento Titular da autorização de colocação no mercado N.o de inscrição no registo comunitário Data de notificação 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

— Suspensão de uma autorização de colocação no mercado [artigo 18.o do Regulamento (CEE) n.o 2309/93 do Conselho]

Data da decisão Nome do medicamento Titular da autorização de colocação no mercado N.o de inscrição no registo comunitário Data de notificação 13.10.2005 Bextra Pharmacia-Pfizer EEIG, Sandwich, Kent, UK-CT13 9NJ EU/1/02/239/001-030 19.10.2005

(1) JO L 214 de 24.8.1993, p. 1..