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Document 52008XC0125(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 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 December 2007 to 31 December 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 December 2007 to 31 December 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 19, 25.1.2008, p. 4–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
25.1.2008 |
EN |
Official Journal of the European Union |
C 19/4 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007
(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 19/04)
— 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 |
|||||
11.12.2007 |
NEVANAC |
Nepafenac |
|
EU/1/07/433/001 |
Eye drops, suspension |
S01BC10 |
13.12.2007 |
|||||
11.12.2007 |
Pioglitazone/metformin hydrochloride Takeda |
Pioglitazone/metformin hydrochloride |
|
EU/1/07/421/001-009 |
Film-coated tablet |
A10BD05 |
13.12.2007 |
|||||
12.12.2007 |
Olanzapine Teva |
Olanzapine |
|
EU/1/07/427/001-022 |
Film-coated tablet |
N05AH03 |
14.12.2008 |
|||||
EU/1/07/427023-037 |
Orodispersible tablets |
|||||||||||
13.12.2007 |
Atripla |
Efavirenz/emtricitabine/tenofovir disoproxil fumarate |
|
EU/1/07/430/001 |
Film-coated tablet |
J05AR06 |
18.12.2008 |
|||||
18.12.2007 |
Retacrit |
Epoetin zeta |
|
EU/1/07/431/001-019 |
Solution for injection |
B03XA01 |
20.12.2007 |
|||||
18.12.2007 |
Silapo |
Epoetin zeta |
|
EU/1/07/432/001-019 |
Solution for injection |
B03XA01 |
20.12.2007 |
|||||
20.12.2007 |
ISENTRESS |
Raltegravir |
|
EU/1/07/436/001-002 |
Film-coated tablets |
J05AX08 |
2.1.2008 |
— 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 |
||||||
11.12.2007 |
RotaTeq |
|
EU/1/06/348/001-002 |
13.12.2007 |
||||||
11.12.2007 |
TARGRETIN |
|
EU/1/01/178/001 |
13.12.2007 |
||||||
11.12.2007 |
Quintanrix |
|
EU/1/04/301/001-005 |
13.12.2007 |
||||||
11.12.2007 |
Tandemact |
|
EU/1/06/366/005-016 |
13.12.2007 |
||||||
11.12.2007 |
Procomvax |
|
EU/1/99/104/001 |
13.12.2007 |
||||||
11.12.2007 |
Prevenar |
|
EU/1/00/167/001-007 |
13.12.2007 |
||||||
12.12.2007 |
Quadramet |
|
EU/1/97/057/001 |
14.12.2007 |
||||||
12.12.2007 |
Sonata |
|
EU/1/99/102/001-008 |
17.12.2007 |
||||||
|
14.12.2007 |
|||||||||
14.12.2007 |
Avastin |
|
EU/1/04/300/001-002 |
18.12.2007 |
||||||
14.12.2007 |
Ariclaim |
|
EU/1/04/283/008-012 |
18.12.2007 |
||||||
14.12.2007 |
Caelyx |
|
EU/1/96/011/001-004 |
18.12.2007 |
||||||
14.12.2007 |
Diacomit |
|
EU/1/06/367/001-012 |
18.12.2007 |
||||||
14.12.2007 |
RotaTeq |
|
EU/1/06/348/001-002 |
18.12.2007 |
||||||
14.12.2007 |
Rebif |
|
EU/1/98/063/001-007 |
18.12.2007 |
||||||
14.12.2007 |
Velcade |
|
EU/1/04/274/001 |
18.12.2007 |
||||||
18.12.2007 |
Tracleer |
|
EU/1/02/220/001-005 |
20.12.2007 |
||||||
18.12.2007 |
Xelevia |
|
EU/1/07/382/001-018 |
20.12.2007 |
||||||
18.12.2007 |
Infanrix Penta |
|
EU/1/00/153/001-010 |
20.12.2007 |
||||||
18.12.2007 |
Lyrica |
|
EU/1/04/279/001-043 |
21.12.2007 |
||||||
18.12.2007 |
Prezista |
|
EU/1/06/380/001 |
20.12.2007 |
||||||
18.12.2007 |
Betaferon |
|
EU/1/95/003/003-006 |
20.12.2007 |
||||||
18.12.2007 |
Helixate NexGen |
|
EU/1/00/144/004 |
20.12.2007 |
||||||
18.12.2007 |
KOGENATE Bayer |
|
EU/1/00/143/010-011 |
20.12.2007 |
||||||
18.12.2007 |
Zonegran |
|
EU/1/04/307/001-013 |
20.12.2007 |
||||||
18.12.2007 |
NovoMix |
|
EU/1/00/142/004-005 EU/1/00/142/009-010 |
20.12.2007 |
||||||
18.12.2007 |
Insuman |
|
EU/1/97/030/028-109 EU/1/97/030/085-139 |
20.12.2007 |
||||||
18.12.2007 |
Truvada |
|
EU/1/04/305/001 |
20.12.2007 |
||||||
19.12.2007 |
CUBICIN |
|
EU/1/05/328/001-002 |
21.12.2007 |
||||||
19.12.2007 |
Humira |
|
EU/1/03/256/001-010 |
21.12.2007 |
||||||
19.12.2007 |
Tygacil |
|
EU/1/06/336/001 |
21.12.2007 |
||||||
19.12.2007 |
MabCampath |
|
EU/1/01/193/001-002 |
21.12.2007 |
||||||
19.12.2007 |
Lucentis |
|
EU/1/06/374/001 |
21.12.2007 |
||||||
19.12.2007 |
REYATAZ |
|
EU/1/03/267/001-007 |
21.12.2007 |
||||||
19.12.2007 |
Januvia |
|
EU/1/07/383/001-018 |
21.12.2007 |
||||||
19.12.2007 |
Aptivus |
|
EU/1/05/315/001 |
21.12.2007 |
||||||
20.12.2007 |
Infanrix Hexa |
|
EU/1/00/152/001-018 |
24.12.2007 |
||||||
20.12.2007 |
Aldurazyme |
|
EU/1/03/253/001-003 |
24.12.2007 |
||||||
20.12.2007 |
Insulin Human Winthrop |
|
EU/1/06/368/001-087 |
27.12.2007 |
||||||
21.12.2007 |
Remicade |
|
EU/1/99/116/001-003 |
27.12.2007 |
||||||
21.12.2007 |
Keppra |
|
EU/1/00/146/001-030 |
26.12.2007 |
||||||
21.12.2007 |
Mimpara |
|
EU/1/04/292/001-012 |
27.12.2007 |
||||||
21.12.2007 |
Macugen |
|
EU/1/05/325/002 |
2.1.2008 |
||||||
21.12.2007 |
Somavert |
|
EU/1/02/240/001-004 |
27.12.2007 |
||||||
21.12.2007 |
Parareg |
|
EU/1/04/293/001-012 |
2.1.2008 |
||||||
21.12.2007 |
GONAL-F |
|
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 |
2.1.2008 |
||||||
21.12.2007 |
HBVAXPRO |
|
EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 |
26.12.2007 |
— 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 |
|||
18.12.2007 |
Levviax |
|
EU/1/01/192/001-005 |
20.12.2007 |
— 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 |
|||||||||
14.12.2007 |
Suprelorin |
|
EU/2/07/072/001-002 |
18.12.2007 |
|||||||||
19.12.2007 |
Aivlosin |
|
EU/2/04/044/001-006 |
21.12.2007 |
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.