EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52005XC1125(02)
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)
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)
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)
OJ C 293, 25.11.2005, p. 11–14
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
25.11.2005 |
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.