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Document 52008XC0725(03)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008 (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 June 2008 to 30 June 2008 (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 June 2008 to 30 June 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 188, 25.7.2008, p. 6–15
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
25.7.2008 |
EN |
Official Journal of the European Union |
C 188/6 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 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 188/04)
— 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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10.6.2008 |
Tyverb |
Lapatinib |
|
EU/1/07/440/001-002 |
Film-coated tablet |
L01XE07 |
12.6.2008 |
— 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 |
|||||||
|
2.6.2008 |
Xyrem |
|
EU/1/05/312/001 |
4.6.2008 |
|||||||
|
2.6.2008 |
Dafiro |
|
EU/1/06/371/001-033 |
4.6.2008 |
|||||||
|
2.6.2008 |
Copalia |
|
EU/1/06/372/001-033 |
4.6.2008 |
|||||||
|
3.6.2008 |
Exforge |
|
EU/1/06/370/001-033 |
5.6.2008 |
|||||||
|
3.6.2008 |
Imprida |
|
EU/1/06/373/001-003 |
5.6.2008 |
|||||||
|
4.6.2008 |
Evoltra |
|
EU/1/06/334/001-004 |
6.6.2008 |
|||||||
|
|||||||||||
|
6.6.2008 |
Vaniqa |
|
EU/1/01/173/001-003 |
10.6.2008 |
|||||||
|
11.6.2008 |
||||||||||
|
10.6.2008 |
Olanzapine Neopharma |
|
EU/1/07/426/001-011 |
12.6.2008 |
|||||||
|
10.6.2008 |
Imprida |
|
EU/1/06/373/001-033 |
12.6.2008 |
|||||||
|
10.6.2008 |
Irbesartan BMS |
|
EU/1/06/375/001-033 |
12.6.2008 |
|||||||
|
10.6.2008 |
Exforge |
|
EU/1/06/370/001-033 |
12.6.2008 |
|||||||
|
10.6.2008 |
Copalia |
|
EU/1/06/372/001-033 |
12.6.2008 |
|||||||
|
10.6.2008 |
Aprovel |
|
EU/1/97/046/001-039 |
12.6.2008 |
|||||||
|
10.6.2008 |
Olanzapine Teva |
|
EU/1/07/427/001-057 |
12.6.2008 |
|||||||
|
10.6.2008 |
Karvea |
|
EU/1/97/049/001-039 |
12.6.2008 |
|||||||
|
10.6.2008 |
Karvezide |
|
EU/1/98/085/001-034 |
12.6.2008 |
|||||||
|
10.6.2008 |
CoAprovel |
|
EU/1/98/086/001-034 |
12.6.2008 |
|||||||
|
10.6.2008 |
Irbesartan HCT BMS |
|
EU/1/06/369/001-028 |
12.6.2008 |
|||||||
|
10.6.2008 |
Irbesartan HCT Winthrop |
|
EU/1/06/377/001-028 |
12.6.2008 |
|||||||
|
10.6.2008 |
Dafiro |
|
EU/1/06/371/001-033 |
12.6.2008 |
|||||||
|
11.6.2008 |
Irbesartan Winthrop |
|
EU/1/06/376/001-033 |
13.6.2008 |
|||||||
|
12.6.2008 |
Optison |
|
EU/1/98/065/001-002 |
16.6.2008 |
|||||||
|
17.6.2008 |
Xenical |
|
EU/1/98/071/001-006 |
19.6.2008 |
|||||||
|
18.6.2008 |
Insuman - |
|
EU/1/97/030/028-139 |
20.6.2008 |
|||||||
|
18.6.2008 |
Novomix |
|
EU/1/00/142/004-005 EU/1/00/142/009-022 |
20.6.2008 |
|||||||
|
18.6.2008 |
Insulin Human Winthrop |
|
EU/1/06/368/001-057 |
20.6.2008 |
|||||||
|
18.6.2008 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-004 |
20.6.2008 |
|||||||
|
18.6.2008 |
Remicade |
|
EU/1/99/116/001-003 |
20.6.2008 |
|||||||
|
18.6.2008 |
Atripla |
|
EU/1/07/430/001 |
23.6.2008 |
|||||||
|
18.6.2008 |
Tamiflu |
|
EU/1/02/222/001-004 |
20.6.2008 |
|||||||
|
18.6.2008 |
Parareg |
|
EU/1/04/293/001-012 |
20.6.2008 |
|||||||
|
18.6.2008 |
Agenerase |
|
EU/1/00/148/001-004 |
20.6.2008 |
|||||||
|
18.6.2008 |
Renagel |
|
EU/1/99/123/005-012 |
20.6.2008 |
|||||||
|
19.6.2008 |
Twinrix Paediatric |
|
EU/1/97/029/001-010 |
23.6.2008 |
|||||||
|
19.6.2008 |
Rotarix |
|
EU/1/05/330/001-004 |
23.6.2008 |
|||||||
|
19.6.2008 |
Cholestagel |
|
EU/1/03/268/001-004 |
23.6.2008 |
|||||||
|
19.6.2008 |
Plavix |
|
EU/1/98/069/001a-007b, 008-010 |
23.6.2008 |
|||||||
|
19.6.2008 |
Iscover |
|
EU/1/98/070/001a-007b, 008-010 |
23.6.2008 |
|||||||
|
19.6.2008 |
InductOs |
|
EU/1/02/226/001 |
23.6.2008 |
|||||||
|
19.6.2008 |
Paxene |
|
EU/1/99/113/001-004 |
24.6.2008 |
|||||||
|
19.6.2008 |
Mimpara |
|
EU/1/04/292/001-012 |
23.6.2008 |
|||||||
|
19.6.2008 |
Twinrix Adult |
|
EU/1/96/020/001-009 |
23.6.2008 |
|||||||
|
20.6.2008 |
PEGASYS |
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EU/1/02/221/001-010 |
24.6.2008 |
|||||||
|
20.6.2008 |
Viracept |
|
EU/1/97/054/001 EU/1/97/054/004-005 |
24.6.2008 |
|||||||
|
20.6.2008 |
Azopt |
|
EU/1/00/129/001-003 |
24.6.2008 |
|||||||
|
20.6.2008 |
Tysabri |
|
EU/1/06/346/001 |
26.6.2008 |
|||||||
|
20.6.2008 |
REYATAZ |
|
EU/1/03/267/001-009 |
24.6.2008 |
|||||||
|
20.6.2008 |
Evra |
|
EU/1/02/223/001-003 |
24.6.2008 |
|||||||
|
20.6.2008 |
Crixivan |
|
EU/1/96/024/001-005 EU/1/96/024/007-08 EU/1/96/024/010 |
24.6.2008 |
|||||||
|
20.6.2008 |
Apidra |
|
EU/1/04/285/001-036 |
24.6.2008 |
|||||||
|
20.6.2008 |
Prezista |
|
EU/1/06/380/001 |
24.6.2008 |
|||||||
|
20.6.2008 |
ProQuad |
|
EU/1/05/323/001-013 |
24.6.2008 |
|||||||
|
20.6.2008 |
Abilify |
|
EU/1/04/276/036 |
24.6.2008 |
|||||||
|
20.6.2008 |
M-M-RVAXPRO |
|
EU/1/06/337/001-013 |
24.6.2008 |
|||||||
|
20.6.2008 |
Puregon |
|
EU/1/96/008/001-041 |
24.6.2008 |
|||||||
|
20.6.2008 |
Kaletra |
|
EU/1/01/172/001-006 |
24.6.2008 |
|||||||
|
20.6.2008 |
Vistide |
|
EU/1/97/037/001- |
24.6.2008 |
|||||||
|
20.6.2008 |
Raptiva |
|
EU/1/04/291/001-002 |
24.6.2008 |
|||||||
|
20.6.2008 |
Prevenar |
|
EU/1/00/167/001-008 |
24.6.2008 |
|||||||
|
20.6.2008 |
Rapilysin |
|
EU/1/97/033/002 |
24.6.2008 |
|||||||
|
24.6.2008 |
||||||||||
|
20.6.2008 |
Avonex |
|
EU/1/97/033/002-004 |
24.6.2008 |
|||||||
|
20.6.2008 |
Vfend |
|
EU/1/02/212/001-026 |
24.6.2008 |
|||||||
|
20.6.2008 |
Telzir |
|
EU/1/04/282/001-002 |
24.6.2008 |
|||||||
|
23.6.2008 |
Humira |
|
EU/1/03/256/001-010 |
25.6.2008 |
|||||||
|
25.6.2008 |
Optisulin |
|
EU/1/00/133/001-007 |
27.6.2008 |
|||||||
|
25.6.2008 |
Baraclude |
|
EU/1/06/343/001-007 |
27.6.2008 |
|||||||
|
25.6.2008 |
Lantus |
|
EU/1/00/134/001-037 |
27.6.2008 |
|||||||
|
25.6.2008 |
Temodal |
|
EU/1/98/096/001-012 |
27.6.2008 |
|||||||
|
25.6.2008 |
Elaprase |
|
EU/1/06/365/001-003 |
27.6.2008 |
|||||||
|
27.6.2008 |
Abseamed |
|
EU/1/07/412/001-020 |
1.7.2008 |
|||||||
|
30.6.2008 |
Sprycel |
|
EU/1/06/363/001-009 |
2.7.2008 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected
|
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 |
||||||
|
25.6.2008 |
Tygacil |
|
EU/1/06/336/001 |
27.6.2008 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004) (applicable with effect from 1 January 2009)
|
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 |
|||||
|
10.6.2008 |
Zenapax |
|
EU/1/99/098/001-002 |
12.6.2008 |
— 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 |
|||||
|
23.6.2008 |
Posatex |
Orbifloxacin, Mometasone furoate, Posaconazole |
|
EU/2/08/081/001-003 |
Ear drops, suspension |
QS02CA91 |
25.6.2008 |
|||||
|
25.6.2008 |
EQUIOXX |
Firocoxib |
|
EU/2/08/083/001 |
Oral paste |
QM01AH90 |
27.6.2008 |
— 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 |
|||||
|
3.6.2008 |
Convenia |
|
EU/2/06/059/001 |
5.6.2008 |
|||||
|
4.6.2008 |
Aivlosin |
|
EU/2/04/044/007 |
6.6.2008 |
|||||
|
13.6.2008 |
Gonazon |
|
EU/2/03/040/001-002 |
17.6.2008 |
|||||
|
20.6.2008 |
DRAXXIN |
|
EU/2/03/041/001-005 |
24.6.2008 |
|||||
|
23.6.2008 |
Nobilis Influenza H7N1 |
|
EU/2/07/073/001-004 |
25.6.2008 |
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.