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Document 52009XC0529(01)
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 April 2009 to 30 April 2009 (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 authorisations in respect of medicinal products from 1 April 2009 to 30 April 2009 (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 authorisations in respect of medicinal products from 1 April 2009 to 30 April 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 121, 29.5.2009, p. 3–13
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
29.5.2009 |
EN |
Official Journal of the European Union |
C 121/3 |
Summary of Community decisions on marketing authorisations in respect of medicinal products
from 1 April 2009 to 30 April 2009
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2009/C 121/03
— Issuing of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|||||||
|
17.4.2009 |
Rivastigmine Teva |
Rivastigmine |
|
EU/1/09/513/001-020 |
Capsule, hard |
N06DA03 |
21.4.2009 |
|||||||
|
17.4.2009 |
CONBRIZA |
Bazedoxifene |
|
EU/1/09/511/001-004 |
Film-coated tablet |
G03XC02 |
21.4.2009 |
|||||||
|
20.4.2009 |
Removab |
Catumaxomab |
|
EU/1/09/512/001-002 |
Concentrate for solution for infusion |
L01XC09 |
22.4.2009 |
|||||||
|
21.4.2009 |
Exalief |
Eslicarbazepine acetate |
|
EU/1/09/520/001-020 |
Tablet |
N03AF04 |
23.4.2009 |
|||||||
|
21.4.2009 |
Zebinix |
Eslicarbazepine acetate |
|
EU/1/09/514/001-020 |
Tablet |
N03AF04 |
23.4.2009 |
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Rejected
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||||
|
27.4.2009 |
Sovrima |
|
— |
29.4.2009 |
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||||||||
|
2.4.2009 |
Xarelto |
|
EU/1/08/472/001-008 |
6.4.2009 |
||||||||
|
2.4.2009 |
Altargo |
|
EU/1/07/390/001-004 |
4.4.2009 |
||||||||
|
2.4.2009 |
Neupro |
|
EU/1/05/331/001-055 |
6.4.2009 |
||||||||
|
2.4.2009 |
Abraxane |
|
EU/1/07/428/001 |
6.4.2009 |
||||||||
|
2.4.2009 |
Combivir |
|
EU/1/98/058/001-002 |
4.4.2009 |
||||||||
|
3.4.2009 |
Optimark |
|
EU/1/07/398/001-014 |
8.4.2008 |
||||||||
|
3.4.2009 |
Intrinsa |
|
EU/1/06/352/001-003 |
8.4.2009 |
||||||||
|
3.4.2009 |
Livensa |
|
EU/1/06/351/001-003 |
8.4.2009 |
||||||||
|
3.4.2009 |
Riprazo |
|
EU/1/07/409/001-020 |
8.4.2009 |
||||||||
|
3.4.2009 |
Enviage |
|
EU/1/07/406/001-020 |
8.4.2009 |
||||||||
|
3.4.2009 |
Sprimeo |
|
EU/1/07/407/001-020 |
8.4.2009 |
||||||||
|
3.4.2009 |
Tekturna |
|
EU/1/07/408/001-020 |
8.4.2009 |
||||||||
|
3.4.2009 |
Rasilez |
|
EU/1/07/405/001-020 |
8.4.2009 |
||||||||
|
3.4.2009 |
YENTREVE |
|
EU/1/04/280/001-008 |
8.4.2009 |
||||||||
|
3.4.2009 |
DULOXETINE BOEHRINGER INGELHEIM |
|
EU/1/08/471/001-012 |
8.4.2009 |
||||||||
|
7.4.2009 |
Vectibix |
|
EU/1/07/423/001-003 |
9.4.2009 |
||||||||
|
7.4.2009 |
ADROVANCE |
|
EU/1/06/364/001-009 |
14.4.2009 |
||||||||
|
7.4.2009 |
FOSAVANCE |
|
EU/1/05/310/001-009 |
14.4.2009 |
||||||||
|
7.4.2009 |
Champix |
|
EU/1/06/360/001-012 |
9.4.2009 |
||||||||
|
7.4.2009 |
Volibris |
|
EU/1/08/451/001-004 |
9.4.2009 |
||||||||
|
7.4.2009 |
Irbesartan |
|
EU/1/06/375/001-033 |
9.4.2009 |
||||||||
|
7.4.2009 |
PritorPlus |
|
EU/1/02/215/001-021 |
9.4.2009 |
||||||||
|
7.4.2009 |
KOGENATE Bayer |
|
EU/1/00/143/001-011 |
9.4.2009 |
||||||||
|
7.4.2009 |
Tasigna |
|
EU/1/07/422/001-004 |
9.4.2009 |
||||||||
|
7.4.2009 |
Irbesartan HCT BMS |
|
EU/1/06/369/001-028 |
9.4.2009 |
||||||||
|
7.4.2009 |
Helixate NexGen |
|
EU/1/00/144/001-004 |
9.4.2009 |
||||||||
|
7.4.2009 |
Kinzalkomb |
|
EU/1/02/214/001-015 |
9.4.2009 |
||||||||
|
7.4.2009 |
Nexavar |
|
EU/1/06/342/001 |
9.4.2009 |
||||||||
|
7.4.2009 |
Fluticasone furoate GSK |
|
EU/1/08/474/001-003 |
9.4.2009 |
||||||||
|
7.4.2009 |
Protopic |
|
EU/1/02/201/001-006 |
9.4.2009 |
||||||||
|
7.4.2009 |
MIRCERA |
|
EU/1/07/400/001-021 |
9.4.2009 |
||||||||
|
7.4.2009 |
Integrilin |
|
EU/1/99/109/001-002 |
9.4.2009 |
||||||||
|
7.4.2009 |
Ziagen |
|
EU/1/99/112/001-002 |
9.4.2009 |
||||||||
|
7.4.2009 |
Avamys |
|
EU/1/07/434/001-003 |
9.4.2009 |
||||||||
|
7.4.2009 |
MicardisPlus |
|
EU/1/02/213/001-023 |
9.4.2009 |
||||||||
|
7.4.2009 |
Thyrogen |
|
EU/1/99/122/001-002 |
9.4.2009 |
||||||||
|
8.4.2009 |
Irbesartan Winthrop |
|
EU/1/06/376/001-033 |
15.4.2009 |
||||||||
|
8.4.2009 |
PEGASYS |
|
EU/1/02/221/001-010 |
15.4.2009 |
||||||||
|
16.4.2009 |
ReFacto AF |
|
EU/1/99/103/001-004 |
20.4.2009 |
||||||||
|
16.4.2009 |
Levemir |
|
EU/1/04/278/001-009 |
20.4.2009 |
||||||||
|
16.4.2009 |
Thelin |
|
EU/1/06/353/001-005 |
21.4.2009 |
||||||||
|
17.4.2009 |
CUBICIN |
|
EU/1/05/328/001-002 |
21.4.2009 |
||||||||
|
17.4.2009 |
Mirapexin |
|
EU/1/97/051/001-006 EU/1/97/051/009-012 |
21.4.2009 |
||||||||
|
17.4.2009 |
Irbesartan HCT Winthrop |
|
EU/1/06/377/001-028 |
21.4.2009 |
||||||||
|
17.4.2009 |
Sifrol |
|
EU/1/97/050/001-006 EU/1/97/050/009-012 |
21.4.2009 |
||||||||
|
21.4.2009 |
Trisenox |
|
EU/1/02/204/001 |
23.4.2009 |
||||||||
|
21.4.2009 |
Kivexa |
|
EU/1/04/298/001-003 |
23.4.2009 |
||||||||
|
21.4.2009 |
Prepandrix |
|
EU/1/08/453/001 |
23.4.2009 |
||||||||
|
21.4.2009 |
Tasigna |
|
EU/1/07/422/001-004 |
23.4.2009 |
||||||||
|
21.4.2009 |
Pandemrix |
|
EU/1/08/452/001 |
23.4.2009 |
||||||||
|
21.4.2009 |
Angiox |
|
EU/1/04/289/001-002 |
23.4.2009 |
||||||||
|
21.4.2009 |
Abilify |
|
EU/1/04/276/001-020 EU/1/04/276/024-036 |
23.4.2009 |
||||||||
|
21.4.2009 |
ISENTRESS |
|
EU/1/07/436/001-002 |
23.4.2009 |
||||||||
|
21.4.2009 |
Renagel |
|
EU/1/99/123/005-012 |
23.4.2009 |
||||||||
|
22.4.2009 |
Viread |
|
EU/1/01/200/001-002 |
24.4.2009 |
||||||||
|
22.4.2009 |
Liprolog |
|
EU/1/01/195/022-027 |
24.4.2009 |
||||||||
|
22.4.2009 |
Sustiva |
|
EU/1/99/110/001-005 EU/1/99/110/008-010 |
24.4.2009 |
||||||||
|
22.4.2009 |
Stocrin |
|
EU/1/99/111/001-005 EU/1/99/111/008-011 |
24.4.2009 |
||||||||
|
22.4.2009 |
BeneFIX |
|
EU/1/97/047/001-007 |
24.4.2009 |
||||||||
|
22.4.2009 |
Rebif |
|
EU/1/98/063/001-010 |
24.4.2009 |
||||||||
|
22.4.2009 |
Cervarix |
|
EU/1/07/419/001-012 |
24.4.2009 |
||||||||
|
22.4.2009 |
Enviage |
|
EU/1/07/406/001-020 |
24.4.2009 |
||||||||
|
22.4.2009 |
Riprazo |
|
EU/1/07/409/001-020 |
24.4.2009 |
||||||||
|
22.4.2009 |
Tekturna |
|
EU/1/07/408/001-020 |
24.4.2009 |
||||||||
|
22.4.2009 |
Rasilez |
|
EU/1/07/405/001-020 |
24.4.2009 |
||||||||
|
22.4.2009 |
Sprimeo |
|
EU/1/07/407/001-020 |
27.4.2009 |
||||||||
|
23.4.2009 |
Rebetol |
|
EU/1/99/107/001-005 |
28.4.2009 |
||||||||
|
23.4.2009 |
Corlentor |
|
EU/1/05/317/001-014 |
7.5.2009 |
||||||||
|
23.4.2009 |
Procoralan |
|
EU/1/05/316/001-014 |
7.5.2009 |
||||||||
|
23.4.2009 |
INTELENCE |
|
EU/1/08/468/001 |
28.4.2009 |
||||||||
|
23.4.2009 |
EVICEL |
|
EU/1/08/473/001-003 |
28.4.2009 |
||||||||
|
24.4.2009 |
KOGENATE Bayer |
|
EU/1/00/143/001-011 |
28.4.2009 |
||||||||
|
24.4.2009 |
Helixate NexGen |
|
EU/1/00/144/001-004 |
28.4.2009 |
||||||||
|
27.4.2009 |
Advagraf |
|
EU/1/07/387/001-013 |
29.4.2009 |
||||||||
|
29.4.2009 |
Glivec |
|
EU/1/01/198/001-013 |
5.5.2009 |
||||||||
|
29.4.2009 |
Evoltra |
|
EU/1/06/334/001-004 |
5.5.2009 |
||||||||
|
29.4.2009 |
Rapamune |
|
EU/1/01/171/001 EU/1/01/171/007-010 |
5.5.2009 |
||||||||
|
30.4.2009 |
NovoRapid |
|
EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 |
5.5.2009 |
||||||||
|
30.4.2009 |
TachoSil |
|
EU/1/04/277/001-004 |
5.5.2009 |
||||||||
|
30.4.2009 |
Xagrid |
|
EU/1/04/295/001 |
5.5.2009 |
||||||||
|
30.4.2009 |
Kentera |
|
EU/1/03/270/001-003 |
5.5.2009 |
— Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
|||||
|
17.4.2009 |
Raptiva |
|
EU/1/04/291/001-003 |
21.4.2009 |
— Issuing of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||||
|
16.4.2009 |
Netvax |
Clostridium perfringens type A toxoid |
|
EU/2/09/093/001-002 |
Emulsion for injection |
QI01A08 |
20.4.2009 |
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||||
|
27.4.2009 |
Equilis StrepE |
|
EU/2/04/043/001 |
29.4.2009 |
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 |
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Canary Wharf |
|
London |
|
E14 4HB |
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UNITED KINGDOM |
(1) OJ L 136, 30.4.2004, p. 1.