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28.11.2008 |
EN |
Official Journal of the European Union |
C 305/3 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 2008
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
(2008/C 305/04)
— 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 |
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|
1.10.2008 |
Tadalafil Lilly |
Tadalafil |
|
EU/1/08/476/001-004 |
Film-coated tablet |
G04B E08 |
3.10.2008 |
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|
6.10.2008 |
EVICEL |
Human fibrinogen/ human thrombin |
|
EU/1/08/473/001-003 |
Solutions for sealant |
B02BC |
9.10.2008 |
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|
6.10.2008 |
Fluticasone furoate GSK |
Fluticasone furoate |
|
EU/1/08/474/001-003 |
Nasal spray suspension |
R01AD12 |
8.10.2008 |
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|
7.10.2008 |
Olanzapine Mylan |
Olanzapine |
|
EU/1/08/475/001-034 |
Film-coated tablet |
N05AH03 |
9.10.2008 |
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|
7.10.2008 |
Ceplene |
Histamine dihydrochloride |
|
EU/1/08/477/001 |
Solution for injection |
L03AX14 |
9.10.2008 |
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|
8.10.2008 |
Duloxetine Boehringer Ingelheim |
Duloxetine |
|
EU/1/08/471/001-012 |
Gastro-resistant capsule |
N06AX21 |
10.10.2008 |
— 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 |
||||||
|
1.10.2008 |
Karvezide |
|
EU/1/98/085/001-034 |
3.10.2008 |
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|
1.10.2008 |
CoAprovel |
|
EU/1/98/086/001-034 |
3.10.2008 |
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|
8.10.2008 |
Simulect |
|
EU/1/98/084/001-002 |
10.10.2008 |
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|
9.10.2008 |
Tasmar |
|
EU/1/97/044/001-008 |
14.10.2008 |
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|
13.10.2008 |
Yondelis |
|
EU/1/07/417/001-002 |
15.10.2008 |
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|
13.10.2008 |
HBVAXPRO |
|
EU/1/01/183/030-032 |
15.10.2008 |
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|
13.10.2008 |
Galvus |
|
EU/1/07/414/018 |
15.10.2008 |
||||||
|
14.10.2008 |
DepoCyte |
|
EU/1/01/187/001 |
16.10.2008 |
||||||
|
20.10.2008 |
Onsenal |
|
EU/1/03/259/001-006 |
22.10.2008 |
||||||
|
20.10.2008 |
Thalidomide Pharmion |
|
EU/1/08/443/001 |
22.10.2008 |
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|
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|
21.10.2008 |
Telzir |
|
EU/1/04/282/001-002 |
23.10.2008 |
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|
21.10.2008 |
Aptivus |
|
EU/1/05/315/001 |
23.10.2008 |
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|
22.10.2008 |
Abseamed |
|
EU/1/07/412/001-020 |
24.10.2008 |
||||||
|
23.10.2008 |
NeoRecormon |
|
EU/1/97/031/019-046 |
27.10.2008 |
||||||
|
23.10.2008 |
Cellcept |
|
EU/1/96/005/001-006 |
27.10.2008 |
||||||
|
24.10.2008 |
Prezista |
|
EU/1/06/380/001 |
28.10.2008 |
||||||
|
24.10.2008 |
Vectibix |
|
EU/1/07/423/001-003 |
28.10.2008 |
||||||
|
27.10.2008 |
Myocet |
|
EU/1/00/141/001 |
29.10.2008 |
||||||
|
27.10.2008 |
Revlimid |
|
EU/1/07/391/001-004 |
29.10.2008 |
||||||
|
27.10.2008 |
REYATAZ |
|
EU/1/03/267/001-010 |
29.10.2008 |
||||||
|
27.10.2008 |
Lucentis |
|
EU/1/06/374/001 |
29.10.2008 |
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|
28.10.2008 |
Nespo |
|
EU/1/01/184/001-073 |
30.10.2008 |
||||||
|
28.10.2008 |
RotaTeq |
|
EU/1/06/348/001-002 |
30.10.2008 |
||||||
|
28.10.2008 |
CELSENTRI |
|
EU/1/07/418/001-010 |
30.10.2008 |
||||||
|
28.10.2008 |
Valtropin |
|
EU/1/06/335/001 |
5.11.2008 |
||||||
|
28.10.2008 |
Revatio |
|
EU/1/05/318/001 |
30.10.2008 |
||||||
|
28.10.2008 |
Zavesca |
|
EU/1/02/238/001 |
30.10.2008 |
||||||
|
28.10.2008 |
Advagraf |
|
EU/1/07/387/001-010 |
30.10.2008 |
||||||
|
28.10.2008 |
Agenerase |
|
EU/1/00/148/001-004 |
30.10.2008 |
||||||
|
28.10.2008 |
Ketek |
|
EU/1/01/191/001-005 |
30.10.2008 |
||||||
|
28.10.2008 |
Aranesp |
|
EU/1/01/185/001-022 EU/1/01/185/031-073 |
30.10.2008 |
||||||
|
29.10.2008 |
Parareg |
|
EU/1/04/293/001-012 |
31.10.2008 |
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|
29.10.2008 |
Mimpara |
|
EU/1/04/292/001-012 |
31.10.2008 |
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|
29.10.2008 |
Binocrit |
|
EU/1/07/410/001-020 |
31.10.2008 |
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|
29.10.2008 |
Betaferon |
|
EU/1/95/003/003-008 |
31.10.2008 |
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|
29.10.2008 |
Crixivan |
|
EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 |
31.10.2008 |
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|
29.10.2008 |
Epoetin alfa Hexal |
|
EU/1/07/411/001-020 |
31.10.2008 |
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|
30.10.2008 |
Rapamune |
|
EU/1/01/171/001 EU/1/01/171/007-010 |
4.11.2008 |
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|
30.10.2008 |
Kaletra |
|
EU/1/01/172/001-006 |
4.11.2008 |
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|
30.10.2008 |
Tysabri |
|
EU/1/06/346/001 |
4.11.2008 |
||||||
|
30.10.2008 |
Tygacil |
|
EU/1/06/336/001 |
4.11.2008 |
||||||
|
30.10.2008 |
Eucreas |
|
EU/1/07/425/001-018 |
4.11.2008 |
||||||
|
30.10.2008 |
PEGASYS |
|
EU/1/02/221/001-010 |
4.11.2008 |
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|
30.10.2008 |
Infanrix Penta |
|
EU/1/00/153/001-010 |
4.11.2008 |
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|
30.10.2008 |
Hycamtin |
|
EU/1/96/027/001 EU/1/96/027/003-007 |
4.11.2008 |
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|
30.10.2008 |
Myozyme |
|
EU/1/06/333/001-003 |
4.11.2008 |
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|
30.10.2008 |
SUTENT |
|
EU/1/06/347/001-006 |
4.11.2008 |
||||||
|
31.10.2008 |
Sebivo |
|
EU/1/07/388/001-002 |
4.11.2008 |
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|
31.10.2008 |
Gardasil |
|
EU/1/06/357/001-021 |
4.11.2008 |
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|
31.10.2008 |
Silgard |
|
EU/1/06/358/001-021 |
4.11.2008 |
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|
31.10.2008 |
Tamiflu |
|
EU/1/02/222/001-004 |
4.11.2008 |
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|
31.10.2008 |
Invirase |
|
EU/1/96/026/001-002 |
4.11.2008 |
||||||
|
31.10.2008 |
CELSENTRI |
|
EU/1/07/418/001-010 |
4.11.2008 |
||||||
|
31.10.2008 |
Xeloda |
|
EU/1/00/163/001-002 |
4.11.2008 |
||||||
|
31.10.2008 |
Rebetol |
|
EU/1/99/107/001-005 |
4.11.2008 |
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|
31.10.2008 |
Galvus |
|
EU/1/07/414/001-010 EU/1/07/414/018 |
4.11.2008 |
||||||
|
31.10.2008 |
Infanrix hexa |
|
EU/1/00/152/001-018 |
4.11.2008 |
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|
31.10.2008 |
Insulin human Winthrop |
|
EU/1/06/368/088-142 |
4.11.2008 |
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|
31.10.2008 |
ViraferonPeg |
|
EU/1/00/132/001-050 |
4.11.2008 |
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|
31.10.2008 |
PegIntron |
|
EU/1/00/131/001-050 |
4.11.2008 |
— Withdrawal of a marketing authorization (Article 13 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 |
|||||
|
13.10.2008 |
Viraferon |
|
EU/1/99/128/001-037 |
15.10.2008 |
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|
29.10.2008 |
Forcaltonin |
|
EU/1/98/093/002 |
3.11.2008 |
— 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 |
|||||
|
9.10.2008 |
SevoFlo |
|
EU/2/02/035/007 |
14.10.2008 |
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|
13.10.2008 |
Vaxxitek HVT + IBD |
|
EU/2/02/032/001 |
15.10.2008 |
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|
17.10.2008 |
Previcox |
|
EU/2/04/045/001-006 |
21.10.2008 |
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|
20.10.2008 |
Aivlosin |
|
EU/2/04/044/001-002 |
22.10.2008 |
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|
21.10.2008 |
Convenia |
|
EU/2/06/059/001 |
23.10.2008 |
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 |
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7 Westferry Circus |
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Canary Wharf |
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London E14 4HB |
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United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.