|
28.12.2007 |
EN |
Official Journal of the European Union |
C 316/42 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2007 to 30 November 2007
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2007/C 316/05)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||||||
|
14.11.2007 |
Olanzapine Neopharma |
Olanzapine |
|
EU/1/07/426/001-011 |
Coated tablets |
N05AH03 |
16.11.2007 |
||||||
|
14.11.2007 |
Eucreas |
Vildagliptin/Metformin hydrochloride |
|
EU/1/07/425/001-018 |
Film-coated tablets |
(Non applicable) |
16.11.2007 |
||||||
|
19.11.2007 |
Tasigna |
Nilotinib |
|
EU/1/07/422/001-004 |
Capsule, hard |
L01XE08 |
21.11.2007 |
||||||
|
19.11.2007 |
TORISEL |
Temsirolimus |
|
EU/1/07/424/001 |
Concentrate and diluent for solution for infusion |
(Non applicable) |
21.11.2007 |
||||||
|
23.11.2007 |
Cyanokit |
Hydroxocobalamin |
|
EU/1/07/420/001 |
Powder for solution for infusion |
V03AB33 |
27.11.2007 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
||||||
|
8.11.2007 |
PhotoBarr |
|
EU/1/04/272/001-002 |
12.11.2007 |
||||||
|
8.11.2007 |
Arava |
|
EU/1/99/118/001-010 |
12.11.2007 |
||||||
|
12.11.2007 |
Tandemact |
|
EU/1/06/366/001-016 |
14.11.2007 |
||||||
|
13.11.2007 |
Combivir |
|
EU/1/98/058/001-002 |
16.11.2007 |
||||||
|
13.11.2007 |
Betaferon |
|
EU/1/95/003/003-006 |
15.11.2007 |
||||||
|
13.11.2007 |
Kepivance |
|
EU/1/05/314/001 |
15.11.2007 |
||||||
|
14.11.2007 |
Optisulin |
|
EU/1/00/133/001-008 |
16.11.2007 |
||||||
|
19.11.2007 |
Pegasys |
|
EU/1/02/221/001-010 |
21.11.2007 |
||||||
|
19.11.2007 |
Mabthera |
|
EU/1/98/067/001-002 |
21.11.2007 |
||||||
|
19.11.2007 |
Enbrel |
|
EU/1/99/126/001-018 |
21.11.2007 |
||||||
|
19.11.2007 |
Evista |
|
EU/1/98/073/001-004 |
21.11.2007 |
||||||
|
19.11.2007 |
Optruma |
|
EU/1/98/074/001-004 |
21.11.2007 |
||||||
|
19.11.2007 |
Ferriprox |
|
EU/1/99/108/002-003 |
21.11.2007 |
||||||
|
20.11.2007 |
Rapamune |
|
EU/1/01/171/001 EU/1/01/171/007-012 |
22.11.2007 |
||||||
|
20.11.2007 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-004 |
22.11.2007 |
||||||
|
20.11.2007 |
Glivec |
|
EU/1/01/198/001-015 |
22.11.2007 |
||||||
|
20.11.2007 |
Kaletra |
|
EU/1/01/172/001-005 |
22.11.2007 |
||||||
|
20.11.2007 |
Neulasta |
|
EU/1/02/227/001-003 |
22.11.2007 |
||||||
|
20.11.2007 |
Vivanza |
|
EU/1/03/249/001-012 |
22.11.2007 |
||||||
|
20.11.2007 |
Ziagen |
|
EU/1/99/112/001-002 |
22.11.2007 |
||||||
|
20.11.2007 |
Neupopeg |
|
EU/1/02/228/001-003 |
22.11.2007 |
||||||
|
20.11.2007 |
Lucentis |
|
EU/1/06/374/001 |
22.11.2007 |
||||||
|
21.11.2007 |
AVANDIA |
|
EU/1/00/137/002-018 |
23.11.2007 |
||||||
|
21.11.2007 |
Telzir |
|
EU/1/04/282/001-002 |
23.11.2007 |
||||||
|
21.11.2007 |
Zyprexa Velotab |
|
EU/1/99/125/001-016 |
23.11.2007 |
||||||
|
21.11.2007 |
TRIZIVIR |
|
EU/1/00/156/002-003 |
23.11.2007 |
||||||
|
21.11.2007 |
Ionsys |
|
EU/1/05/326/001 |
26.11.2007 |
||||||
|
21.11.2007 |
Zyprexa |
|
EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 |
23.11.2007 |
||||||
|
21.11.2007 |
Zerene |
|
EU/1/99/099/001-006 |
23.11.2007 |
||||||
|
21.11.2007 |
Sonata |
|
EU/1/99/102/001-008 |
23.11.2007 |
||||||
|
21.11.2007 |
Levitra |
|
EU/1/03/248/001-013 |
23.11.2007 |
||||||
|
21.11.2007 |
Baraclude |
|
EU/1/06/343/001-005 |
23.11.2007 |
||||||
|
22.11.2007 |
SUTENT |
|
EU/1/06/347/001-003 |
26.11.2007 |
||||||
|
22.11.2007 |
Busilvex |
|
EU/1/03/254/001 |
26.11.2007 |
||||||
|
22.11.2007 |
Ariclaim |
|
EU/1/04/283/001-007 |
26.11.2007 |
||||||
|
23.11.2007 |
Avaglim |
|
EU/1/06/349/001-010 |
27.11.2007 |
||||||
|
23.11.2007 |
Combivir |
|
EU/1/98/058/001-002 |
27.11.2007 |
||||||
|
23.11.2007 |
Docetaxel Winthrop |
|
EU/1/07/384/001-002 |
27.11.2007 |
||||||
|
23.11.2007 |
Lantus |
|
EU/1/00/134/001-037 |
27.11.2007 |
||||||
|
23.11.2007 |
Taxotere |
|
EU/1/95/002/001-002 |
27.11.2007 |
||||||
|
29.11.2007 |
Raptiva |
|
EU/1/04/291/001-002 |
3.12.2007 |
||||||
|
30.11.2007 |
Tandemact |
|
EU/1/06/366/005-016 |
4.12.2007 |
||||||
|
30.11.2007 |
Macugen |
|
EU/1/05/325/001-002 |
4.12.2007 |
||||||
|
30.11.2007 |
Truvada |
|
EU/1/04/305/001 |
4.12.2007 |
||||||
|
30.11.2007 |
Agenerase |
|
EU/1/00/148/001-004 |
4.12.2007 |
||||||
|
30.11.2007 |
Remicade |
|
EU/1/99/116/001-003 |
4.12.2007 |
||||||
|
30.11.2007 |
Azopt |
|
EU/1/00/129/001-003 |
4.12.2007 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|||
|
14.11.2007 |
Meloxivet |
Meloxicam |
|
EU/2/07/077/001-005 |
Oral suspension |
QM01AC06 |
16.11.2007 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
||||
|
6.11.2007 |
SevoFlo |
|
EU/2/02/035/001-007 |
8.11.2007 |
||||
|
13.11.2007 |
Quadrisol |
|
EU/2/97/005/001-009 |
15.11.2007 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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The European Medicines Agency |
|
7, Westferry Circus |
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Canary Wharf |
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London E14 4HB |
|
United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.