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Document 52007XC0928(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2007 to 31 August 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2007 to 31 August 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2007 to 31 August 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 228, 28.9.2007, p. 2–10
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
28.9.2007 |
EN |
Official Journal of the European Union |
C 228/2 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2007 to 31 August 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 228/02)
— 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 |
|||||
|
3.8.2007 |
INCRELEX |
Mecasermin |
|
EU/1/07/402/001 |
Solution for injection |
H01AC03 |
7.8.2007 |
|||||
|
22.8.2007 |
Enviage |
Aliskiren |
|
EU/1/07/406/001-020 |
Film-coated tablet |
C09XA02 |
24.8.2007 |
|||||
|
22.8.2007 |
Riprazo |
Aliskiren |
|
EU/1/07/409/001-020 |
Film-coated tablet |
C09XA02 |
24.8.2007 |
|||||
|
22.8.2007 |
Sprimeo |
Aliskiren |
|
EU/1/07/407/001-020 |
Film-coated tablet |
C09XA02 |
24.8.2007 |
|||||
|
22.8.2007 |
Rasilez |
Aliskiren |
|
EU/1/07/405/001-020 |
Film-coated tablet |
C09XA02 |
24.8.2007 |
|||||
|
22.8.2007 |
Tekturna |
Aliskiren |
|
EU/1/07/408/001-020 |
Film-coated tablet |
C09XA02 |
24.8.2007 |
|||||
|
22.8.2007 |
Atriance |
Nelarabine |
|
EU/1/07/403/001 |
Solution for infusion |
L01BB07 |
24.8.2007 |
|||||
|
23.8.2007 |
Flebogammadif |
Human normal immunoglobulin |
|
EU/1/07/404/001-005 |
Solution for infusion |
J06BA02 |
27.8.2007 |
|||||
|
28.8.2007 |
Abseamed |
Epoetin alfa |
|
EU/1/07/412/001-016 |
Solution for injection in a pre-filled syringe |
B03XA01 |
31.8.2007 |
|||||
|
28.8.2007 |
Binocrit |
Epoetin alfa |
|
EU/1/07/410/001-016 |
Solution for injection in a pre-filled syringe |
B03XA01 |
31.8.2007 |
|||||
|
28.8.2007 |
Epoetin alfa hexal |
Epoetin alfa |
|
EU/1/07/411/001-016 |
Solution for injection in a pre-filled syringe |
B03XA01 |
3.9.2007 |
— 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 |
||||||||||
|
1.8.2007 |
Keppra |
|
EU/1/00/146/001-030 |
3.8.2007 |
||||||||||
|
3.8.2007 |
TachoSil |
|
EU/1/04/277/001-004 |
7.8.2007 |
||||||||||
|
7.8.2007 |
BeneFIX |
|
EU/1/97/047/001-007 |
9.8.2007 |
||||||||||
|
10.8.2007 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-004 |
14.8.2007 |
||||||||||
|
10.8.2007 |
Fasturtec |
|
EU/1/00/170/001-002 |
14.8.2007 |
||||||||||
|
10.8.2007 |
Ceprotin |
|
EU/1/01/190/001-002 |
14.8.2007 |
||||||||||
|
10.8.2007 |
Cellcept |
|
EU/1/96/005/001-006 |
14.8.2007 |
||||||||||
|
10.8.2007 |
Rebif |
|
EU/1/98/063/001-007 |
14.8.2007 |
||||||||||
|
10.8.2007 |
Tritanrix HepB |
|
EU/1/96/014/001-003 |
14.8.2007 |
||||||||||
|
10.8.2007 |
Cialis |
|
EU/1/02/237/001-008 |
22.8.2007 |
||||||||||
|
20.8.2007 |
Actos |
|
EU/1/00/150/001-024 |
22.8.2007 |
||||||||||
|
20.8.2007 |
Glustin |
|
EU/1/00/151/001-022 |
22.8.2007 |
||||||||||
|
20.8.2007 |
Competact |
|
EU/1/06/354/001-009 |
22.8.2007 |
||||||||||
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21.8.2007 |
Forsteo |
|
EU/1/03/247/001-002 |
23.8.2007 |
||||||||||
|
21.8.2007 |
Nexavar |
|
EU/1/06/342/001 |
23.8.2007 |
||||||||||
|
21.8.2007 |
Opatanol |
|
EU/1/02/217/001-002 |
23.8.2007 |
||||||||||
|
21.8.2007 |
NeuroBloc |
|
EU/1/00/166/001-003 |
23.8.2007 |
||||||||||
|
21.8.2007 |
Avastin |
|
EU/1/04/300/001-002 |
23.8.2007 |
||||||||||
|
21.8.2007 |
Kiovig |
|
EU/1/05/329/001-005 |
23.8.2007 |
||||||||||
|
22.8.2007 |
Sprycel |
|
EU/1/06/363/001-009 |
24.8.2007 |
||||||||||
|
22.8.2007 |
Luminity |
|
EU/1/06/361/001-002 |
24.8.2007 |
||||||||||
|
22.8.2007 |
Emtriva |
|
EU/1/03/261/001-003 |
24.8.2007 |
||||||||||
|
22.8.2007 |
Baraclude |
|
EU/1/06/343/001-005 |
24.8.2007 |
||||||||||
|
23.8.2007 |
Inovelon |
|
EU/1/06/378/001-016 |
28.8.2007 |
||||||||||
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23.8.2007 |
Stocrin |
|
EU/1/99/111/001-011 |
28.8.2007 |
||||||||||
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23.8.2007 |
Sustiva |
|
EU/1/99/110/001-009 |
28.8.2007 |
||||||||||
|
23.8.2007 |
Orfadin |
|
EU/1/04/303/001-003 |
27.8.2007 |
||||||||||
|
27.8.2007 |
Kivexa |
|
EU/1/04/298/001-002 |
29.8.2007 |
||||||||||
|
27.8.2007 |
Ziagen |
|
EU/1/99/112/001-002 |
29.8.2007 |
||||||||||
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27.8.2007 |
Rapamune |
|
EU/1/01/171/001 EU/1/01/171/007-012 |
29.8.2007 |
||||||||||
|
27.8.2007 |
Prezista |
|
EU/1/06/380/001 |
29.8.2007 |
||||||||||
|
27.8.2007 |
NovoMix |
|
EU/1/00/142/004-005 EU/1/00/142/009-022 |
29.8.2007 |
||||||||||
|
27.8.2007 |
Invanz |
|
EU/1/02/216/001-002 |
29.8.2007 |
||||||||||
|
27.8.2007 |
Tandemact |
|
EU/1/06/366/001-004 |
29.8.2007 |
||||||||||
|
27.8.2007 |
Ebixa |
|
EU/1/02/219/001-015 |
29.8.2007 |
||||||||||
|
29.8.2007 |
Enbrel |
|
EU/1/99/126/001-018 |
31.8.2007 |
||||||||||
|
28.8.2007 |
Cymbalta |
|
EU/1/04/296/001-009 |
31.8.2007 |
||||||||||
|
28.8.2007 |
Xeristar |
|
EU/1/04/297/001-008 |
31.8.2007 |
||||||||||
|
28.8.2007 |
YENTREVE |
|
EU/1/04/280/001-008 |
31.8.2007 |
||||||||||
|
28.8.2007 |
Ariclaim |
|
EU/1/04/283/001-007 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Stalevo |
|
EU/1/03/260/001-018 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Exubera |
|
EU/1/05/327/001-018 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Vistide |
|
EU/1/97/037/001 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Evoltra |
|
EU/1/06/334/001-004 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Xelevia |
|
EU/1/07/382/001-018 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Januvia |
|
EU/1/07/383/001-018 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Quixidar |
|
EU/1/02/207/001-004 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Quixidar |
|
EU/1/02/207/001-004 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Arixtra |
|
EU/1/02/206/001-004 |
31.8.2007 |
||||||||||
|
29.8.2007 |
Arixtra |
|
EU/1/02/206/001-004 |
31.8.2007 |
||||||||||
|
30.8.2007 |
Fuzeon |
|
EU/1/03/252/001-003 |
5.9.2007 |
||||||||||
|
30.8.2007 |
BYETTA |
|
EU/1/06/362/001-004 |
5.9.2007 |
||||||||||
|
30.8.2007 |
Agenerase |
|
EU/1/00/148/001-004 |
5.9.2007 |
||||||||||
|
30.8.2007 |
Aranesp |
|
EU/1/01/185/001-073 |
5.9.2007 |
||||||||||
|
30.8.2007 |
NovoRapid |
|
EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 |
5.9.2007 |
||||||||||
|
30.8.2007 |
Nespo |
|
EU/1/01/184/001-073 |
5.9.2007 |
||||||||||
|
30.8.2007 |
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 |
5.9.2007 |
||||||||||
|
30.8.2007 |
Zyprexa Velotab |
|
EU/1/99/125/001-016 |
5.9.2007 |
||||||||||
|
30.8.2007 |
InductOs |
|
EU/1/02/226/001 |
5.9.2007 |
||||||||||
|
30.8.2007 |
Aldara |
|
EU/1/98/080/001 |
5.9.2007 |
||||||||||
|
5.9.2007 |
|||||||||||||
|
31.8.2007 |
Karvea |
|
EU/1/97/049/001-039 |
6.9.2007 |
||||||||||
|
31.8.2007 |
Aprovel |
|
EU/1/97/046/001-039 |
5.9.2007 |
||||||||||
|
31.8.2007 |
CUBICIN |
|
EU/1/05/328/001-002 |
5.9.2007 |
||||||||||
|
31.8.2007 |
Glustin |
|
EU/1/00/151/001-024 |
5.9.2007 |
||||||||||
|
31.8.2007 |
Mimpara |
|
EU/1/04/292/001-012 |
6.9.2007 |
||||||||||
|
31.8.2007 |
Parareg |
|
EU/1/04/293/001-012 |
6.9.2007 |
||||||||||
|
31.8.2007 |
Epivir |
|
EU/1/96/015/001-005 |
6.9.2007 |
||||||||||
|
31.8.2007 |
Zimulti |
|
EU/1/06/345/001-011 |
6.9.2007 |
||||||||||
|
31.8.2007 |
ACOMPLIA |
|
EU/1/06/344/001-011 |
6.9.2007 |
||||||||||
|
31.8.2007 |
Prevenar |
|
EU/1/00/167/001-007 |
6.9.2007 |
— Suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004)
|
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 |
|||||
|
6.8.2007 |
Viracept |
|
EU/1/97/054/001 EU/1/97/054/003-005 |
8.8.2007 |
— 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 |
|||
|
2.8.2007 |
Dexdomitor |
|
EU/2/02/033/001 |
6.8.2007 |
|||
|
13.8.2007 |
Advocate |
|
EU/2/03/039/001-030 |
15.8.2007 |
|||
|
23.8.2007 |
PRAC-TIC |
|
EU/2/06/066/001-012 |
27.8.2007 |
|||
|
27.8.2007 |
Yarvitan |
|
EU/2/06/063/001-003 |
29.8.2007 |
|||
|
29.8.2007 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
|
The European Medicines Agency |
|
7, Westferry Circus |
|
Canary Wharf |
|
London E14 4HB |
|
United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.