EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52012XC1130(08)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 371, 30.11.2012, p. 7–25
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
30.11.2012 |
EN |
Official Journal of the European Union |
C 371/7 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2012/C 371/03
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||
23.10.2012 |
XALKORI |
crizotinib |
|
EU/1/12/793/001-004 |
Capsule, hard |
L01XE16 |
26.10.2012 |
||
25.10.2012 |
Adcetris |
Brentuximab vedotin |
|
EU/1/12/794/001 |
powder for concentrate for solution for infusion |
L01XC12 |
30.10.2012 |
||
25.10.2012 |
Glybera |
Alipogene tiparvovec |
|
EU/1/12/791/001 |
Solution for injection |
C10AX10 |
29.10.2012 |
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||
25.10.2012 |
Elelyso |
|
— |
29.10.2012 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||
1.10.2012 |
Cialis |
|
EU/1/02/237/001-009 |
3.10.2012 |
||
1.10.2012 |
Conbriza |
|
EU/1/09/511/001-005 |
3.10.2012 |
||
1.10.2012 |
Olanzapine Neopharma |
|
EU/1/07/426/001-011 |
3.10.2012 |
||
1.10.2012 |
Tamiflu |
|
EU/1/02/222/001-005 |
3.10.2012 |
||
4.10.2012 |
Cimzia |
|
EU/1/09/544/001-002 |
8.10.2012 |
||
4.10.2012 |
Orencia |
|
EU/1/07/389/001-009 |
8.10.2012 |
||
4.10.2012 |
Soliris |
|
EU/1/07/393/001 |
8.10.2012 |
||
4.10.2012 |
Topotecan Eagle |
|
EU/1/11/744/002 |
8.10.2012 |
||
4.10.2012 |
Vepacel |
|
EU/1/12/752/001-002 |
8.10.2012 |
||
8.10.2012 |
Biograstim |
|
EU/1/08/450/001-010 |
11.10.2012 |
||
8.10.2012 |
Comtan |
|
EU/1/98/081/001-004 |
10.10.2012 |
||
8.10.2012 |
DuoTrav |
|
EU/1/06/338/001-003 |
10.10.2012 |
||
8.10.2012 |
Vidaza |
|
EU/1/08/488/001 |
10.10.2012 |
||
8.10.2012 |
Zavesca |
|
EU/1/02/238/001 |
10.10.2012 |
||
10.10.2012 |
Aprovel |
|
EU/1/97/046/001-039 |
12.10.2012 |
||
10.10.2012 |
Biopoin |
|
EU/1/09/565/001-028 |
12.10.2012 |
||
10.10.2012 |
Dynastat |
|
EU/1/02/209/001-008 |
12.10.2012 |
||
10.10.2012 |
Emend |
|
EU/1/03/262/001-010 |
15.10.2012 |
||
10.10.2012 |
Karvea |
|
EU/1/97/049/034-039 |
12.10.2012 |
||
10.10.2012 |
Pylobactell |
|
EU/1/98/064/001 |
12.10.2012 |
||
10.10.2012 |
Rapamune |
|
EU/1/01/171/007-010 |
12.10.2012 |
||
10.10.2012 |
Synagis |
|
EU/1/99/117/001-002 |
12.10.2012 |
||
15.10.2012 |
Ceplene |
|
EU/1/08/477/001 |
17.10.2012 |
||
15.10.2012 |
Clopidogrel Apotex |
|
EU/1/09/568/001-018 |
17.10.2012 |
||
15.10.2012 |
Olazax |
|
EU/1/09/597/001-005 |
16.10.2012 |
||
23.10.2012 |
Alimta |
|
EU/1/04/290/001-002 |
26.10.2012 |
||
23.10.2012 |
Glivec |
|
EU/1/01/198/001-013 |
26.10.2012 |
||
23.10.2012 |
Helixate NexGen |
|
EU/1/00/144/001-005 |
26.10.2012 |
||
23.10.2012 |
Humira |
|
EU/1/03/256/001-010 |
26.10.2012 |
||
23.10.2012 |
Kogenate Bayer |
|
EU/1/00/143/004-013 |
26.10.2012 |
||
23.10.2012 |
Nplate |
|
EU/1/08/497/001-008 |
26.10.2012 |
||
23.10.2012 |
NULOJIX |
|
EU/1/11/694/001-002 |
26.10.2012 |
||
23.10.2012 |
Osseor |
|
EU/1/04/287/001-006 |
26.10.2012 |
||
23.10.2012 |
Prolia |
|
EU/1/10/618/001-004 |
26.10.2012 |
||
23.10.2012 |
Protelos |
|
EU/1/04/288/001-006 |
26.10.2012 |
||
23.10.2012 |
Telzir |
|
EU/1/04/282/001-002 |
26.10.2012 |
||
23.10.2012 |
Victoza |
|
EU/1/09/529/001-005 |
26.10.2012 |
||
23.10.2012 |
Visudyne |
|
EU/1/00/140/001 |
26.10.2012 |
||
24.10.2012 |
Adenuric |
|
EU/1/08/447/001-012 |
26.10.2012 |
||
24.10.2012 |
Avastin |
|
EU/1/04/300/001-002 |
26.10.2012 |
||
24.10.2012 |
Baraclude |
|
EU/1/06/343/001-007 |
26.10.2012 |
||
24.10.2012 |
Benlysta |
|
EU/1/11/700/001-002 |
26.10.2012 |
||
24.10.2012 |
Brilique |
|
EU/1/10/655/001-006 |
26.10.2012 |
||
24.10.2012 |
ChondroCelect |
|
EU/1/09/563/001 |
26.10.2012 |
||
24.10.2012 |
Cialis |
|
EU/1/02/237/007-008 |
26.10.2012 |
||
24.10.2012 |
Clopidogrel HCS |
|
EU/1/10/651/001-015 |
26.10.2012 |
||
24.10.2012 |
Daliresp |
|
EU/1/11/668/001-003 |
26.10.2012 |
||
24.10.2012 |
Daxas |
|
EU/1/10/636/001-007 |
26.10.2012 |
||
24.10.2012 |
Dynastat |
|
EU/1/02/209/005-008 |
26.10.2012 |
||
24.10.2012 |
EDURANT |
|
EU/1/11/736/001 |
26.10.2012 |
||
24.10.2012 |
Enbrel |
|
EU/1/99/126/001-022 |
26.10.2012 |
||
24.10.2012 |
Eviplera |
|
EU/1/11/737/001-002 |
26.10.2012 |
||
24.10.2012 |
Exjade |
|
EU/1/06/356/001-009 |
26.10.2012 |
||
24.10.2012 |
Ganfort |
|
EU/1/06/340/001-002 |
26.10.2012 |
||
24.10.2012 |
Humira |
|
EU/1/03/256/001-010 |
26.10.2012 |
||
24.10.2012 |
Invirase |
|
EU/1/96/026/001-002 |
26.10.2012 |
||
24.10.2012 |
Kinzalkomb |
|
EU/1/02/214/001-015 |
26.10.2012 |
||
24.10.2012 |
Komboglyze |
|
EU/1/11/731/001-014 |
26.10.2012 |
||
24.10.2012 |
Libertek |
|
EU/1/11/666/001-003 |
26.10.2012 |
||
24.10.2012 |
MicardisPlus |
|
EU/1/02/213/001-023 |
26.10.2012 |
||
24.10.2012 |
Multaq |
|
EU/1/09/591/001-004 |
26.10.2012 |
||
24.10.2012 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-008 |
26.10.2012 |
||
24.10.2012 |
NovoSeven |
|
EU/1/96/006/001-011 |
26.10.2012 |
||
24.10.2012 |
Onduarp |
|
EU/1/11/729/001-006 |
26.10.2012 |
||
24.10.2012 |
Pandemrix |
|
EU/1/08/452/001 |
26.10.2012 |
||
24.10.2012 |
Possia |
|
EU/1/10/656/001-006 |
26.10.2012 |
||
24.10.2012 |
PREZISTA |
|
EU/1/06/380/001-006 |
26.10.2012 |
||
24.10.2012 |
PritorPlus |
|
EU/1/02/215/001-021 |
26.10.2012 |
||
24.10.2012 |
ReFacto AF |
|
EU/1/99/103/001-009 |
26.10.2012 |
||
24.10.2012 |
RotaTeq |
|
EU/1/06/348/001-002 |
26.10.2012 |
||
24.10.2012 |
SonoVue |
|
EU/1/01/177/002 |
26.10.2012 |
||
24.10.2012 |
Thymanax |
|
EU/1/08/498/001-008 |
26.10.2012 |
||
24.10.2012 |
Trajenta |
|
EU/1/11/707/001-011 |
26.10.2012 |
||
24.10.2012 |
Valdoxan |
|
EU/1/08/499/001-008 |
26.10.2012 |
||
24.10.2012 |
Vimpat |
|
EU/1/08/470/001-013 EU/1/08/470/016-019 |
29.10.2012 |
||
24.10.2012 |
Votrient |
|
EU/1/10/628/001-004 |
26.10.2012 |
||
24.10.2012 |
Zometa |
|
EU/1/01/176/001-009 |
26.10.2012 |
||
25.10.2012 |
Bridion |
|
EU/1/08/466/001-002 |
29.10.2012 |
||
25.10.2012 |
Capecitabine Krka |
|
EU/1/12/763/001-018 |
30.10.2012 |
||
25.10.2012 |
Cinryze |
|
EU/1/11/688/001 |
29.10.2012 |
||
25.10.2012 |
Clopidogrel Teva Pharma |
|
EU/1/09/561/001-011 |
29.10.2012 |
||
25.10.2012 |
Copalia |
|
EU/1/06/372/001-039 |
29.10.2012 |
||
25.10.2012 |
Corlentor |
|
EU/1/05/317/001-014 |
29.10.2012 |
||
25.10.2012 |
Dafiro |
|
EU/1/06/371/001-039 |
29.10.2012 |
||
25.10.2012 |
Efavirenz Teva |
|
EU/1/11/742/001-010 |
30.10.2012 |
||
25.10.2012 |
Eucreas |
|
EU/1/07/425/001-018 |
29.10.2012 |
||
25.10.2012 |
Exforge HCT |
|
EU/1/09/569/001-060 |
29.10.2012 |
||
25.10.2012 |
Fasturtec |
|
EU/1/00/170/001-002 |
26.10.2012 |
||
25.10.2012 |
Ferriprox |
|
EU/1/99/108/001-006 |
29.10.2012 |
||
25.10.2012 |
Firazyr |
|
EU/1/08/461/001-002 |
29.10.2012 |
||
25.10.2012 |
Glidipion |
|
EU/1/12/756/001-027 |
29.10.2012 |
||
25.10.2012 |
Helicobacter test INFAI |
|
EU/1/97/045/001-005 |
29.10.2012 |
||
25.10.2012 |
Humalog |
|
EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010 EU/1/96/007/015-021 EU/1/96/007/023-038 |
30.10.2012 |
||
25.10.2012 |
Incivo |
|
EU/1/11/720/001-002 |
29.10.2012 |
||
25.10.2012 |
Instanyl |
|
EU/1/09/531/001-021 |
29.10.2012 |
||
25.10.2012 |
Irbesartan Teva |
|
EU/1/09/576/001-042 |
30.10.2012 |
||
25.10.2012 |
Isentress |
|
EU/1/07/436/001-002 |
30.10.2012 |
||
25.10.2012 |
Jentadueto |
|
EU/1/12/780/029-034 |
30.10.2012 |
||
25.10.2012 |
Kaletra |
|
EU/1/01/172/001-008 |
30.10.2012 |
||
25.10.2012 |
Kepivance |
|
EU/1/05/314/001 |
29.10.2012 |
||
25.10.2012 |
Kineret |
|
EU/1/02/203/001-004 |
30.10.2012 |
||
25.10.2012 |
Liprolog |
|
EU/1/01/195/001-027 |
29.10.2012 |
||
25.10.2012 |
Olanzapine Glenmark |
|
EU/1/09/587/001-017 |
29.10.2012 |
||
25.10.2012 |
Olanzapine Glenmark Europe |
|
EU/1/09/588/001-012 |
29.10.2012 |
||
25.10.2012 |
Olanzapine Mylan |
|
EU/1/08/475/001-060 |
29.10.2012 |
||
25.10.2012 |
Olazax Disperzi |
|
EU/1/09/592/001-005 |
29.10.2012 |
||
25.10.2012 |
Procoralan |
|
EU/1/05/316/001-014 |
29.10.2012 |
||
25.10.2012 |
Ranexa |
|
EU/1/08/462/001-012 |
30.10.2012 |
||
25.10.2012 |
Synflorix |
|
EU/1/09/508/001-011 |
29.10.2012 |
||
25.10.2012 |
Temomedac |
|
EU/1/09/605/001-012 |
29.10.2012 |
||
25.10.2012 |
Temozolomide HEXAL |
|
EU/1/10/616/001-002 EU/1/10/616/005-006 EU/1/10/616/009-010 EU/1/10/616/013-014 EU/1/10/616/017-018 EU/1/10/616/021-022 EU/1/10/616/025-036 |
30.10.2012 |
||
25.10.2012 |
Temozolomide Sandoz |
|
EU/1/10/617/001-002 EU/1/10/617/005-006 EU/1/10/617/009-010 EU/1/10/617/013-014 EU/1/10/617/017-018 EU/1/10/617/021-022 EU/1/10/617/025-036 |
30.10.2012 |
||
25.10.2012 |
Temozolomide SUN |
|
EU/1/11/697/001-024 |
30.10.2012 |
||
25.10.2012 |
Temozolomide Teva |
|
EU/1/09/606/001-012 |
29.10.2012 |
||
25.10.2012 |
Topotecan Teva |
|
EU/1/09/552/001-004 |
29.10.2012 |
||
25.10.2012 |
Toviaz |
|
EU/1/07/386/019-020 |
29.10.2012 |
||
25.10.2012 |
Tracleer |
|
EU/1/02/220/001-006 |
30.10.2012 |
||
25.10.2012 |
Tredaptive |
|
EU/1/08/459/001-014 |
29.10.2012 |
||
25.10.2012 |
Trevaclyn |
|
EU/1/08/458/001-014 |
29.10.2012 |
||
25.10.2012 |
Twynsta |
|
EU/1/10/648/001-028 |
29.10.2012 |
||
25.10.2012 |
Vectibix |
|
EU/1/07/423/001-003 |
29.10.2012 |
||
29.10.2012 |
Advagraf |
|
EU/1/07/387/009-010 EU/1/07/387/016 EU/1/07/387/026 |
1.11.2012 |
||
29.10.2012 |
Aranesp |
|
EU/1/01/185/001-022 EU/1/01/185/031-111 |
1.11.2012 |
||
29.10.2012 |
ATryn |
|
EU/1/06/355/001-003 |
6.11.2012 |
||
29.10.2012 |
Biograstim |
|
EU/1/08/450/001-010 |
5.11.2012 |
||
29.10.2012 |
Bronchitol |
|
EU/1/12/760/001-002 |
1.11.2012 |
||
29.10.2012 |
Byetta |
|
EU/1/06/362/001-004 |
1.11.2012 |
||
29.10.2012 |
Caelyx |
|
EU/1/96/011/001-004 |
5.11.2012 |
||
29.10.2012 |
CANCIDAS |
|
EU/1/01/196/001 EU/1/01/196/003 |
6.11.2012 |
||
29.10.2012 |
Dificlir |
|
EU/1/11/733/001-004 |
31.10.2012 |
||
29.10.2012 |
Docetaxel Mylan |
|
EU/1/11/748/001-006 |
6.11.2012 |
||
29.10.2012 |
Esbriet |
|
EU/1/11/667/001-004 |
1.11.2012 |
||
29.10.2012 |
Exforge |
|
EU/1/06/370/001-039 |
31.10.2012 |
||
29.10.2012 |
Firdapse |
|
EU/1/09/601/001 |
1.11.2012 |
||
29.10.2012 |
Foscan |
|
EU/1/01/197/001-002 |
31.10.2012 |
||
29.10.2012 |
Fycompa |
|
EU/1/12/776/001-023 |
31.10.2012 |
||
29.10.2012 |
Ibandronic Acid Teva |
|
EU/1/10/642/001-004 |
31.10.2012 |
||
29.10.2012 |
Icandra |
|
EU/1/08/484/001-018 |
1.11.2012 |
||
29.10.2012 |
Imprida |
|
EU/1/06/373/001-039 |
31.10.2012 |
||
29.10.2012 |
INOmax |
|
EU/1/01/194/001-004 |
1.11.2012 |
||
29.10.2012 |
Irbesartan/Hydrochlorothiazide Teva |
|
EU/1/09/583/001-075 |
1.11.2012 |
||
29.10.2012 |
Javlor |
|
EU/1/09/550/001-012 |
31.10.2012 |
||
29.10.2012 |
Leflunomide Teva |
|
EU/1/11/675/001-010 |
6.11.2012 |
||
29.10.2012 |
Levetiracetam Actavis Group |
|
EU/1/11/738/001-003 |
1.11.2012 |
||
29.10.2012 |
Lucentis |
|
EU/1/06/374/001 |
1.11.2012 |
||
29.10.2012 |
Myclausen |
|
EU/1/10/647/001-004 |
31.10.2012 |
||
29.10.2012 |
Myocet |
|
EU/1/00/141/001-002 |
5.11.2012 |
||
29.10.2012 |
Nimvastid |
|
EU/1/09/525/001-050 |
5.11.2012 |
||
29.10.2012 |
Pelzont |
|
EU/1/08/460/001-014 |
31.10.2012 |
||
29.10.2012 |
Pixuvri |
|
EU/1/12/764/001 |
6.11.2012 |
||
29.10.2012 |
Plavix |
|
EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b EU/1/98/069/008-010 EU/1/98/069/011a-011b EU/1/98/069/012 |
2.11.2012 |
||
29.10.2012 |
Plenadren |
|
EU/1/11/715/001-002 |
6.11.2012 |
||
29.10.2012 |
Pravafenix |
|
EU/1/11/679/007 |
6.11.2012 |
||
29.10.2012 |
Pumarix |
|
EU/1/10/664/001 |
6.11.2012 |
||
29.10.2012 |
Raloxifene Teva |
|
EU/1/10/627/001-003 |
6.11.2012 |
||
29.10.2012 |
Ranexa |
|
EU/1/08/462/001-012 |
2.11.2012 |
||
29.10.2012 |
Rapiscan |
|
EU/1/10/643/001 |
6.11.2012 |
||
29.10.2012 |
Repaglinide Krka |
|
EU/1/09/579/001-018 |
5.11.2012 |
||
29.10.2012 |
Repaglinide Teva |
|
EU/1/09/530/001-015 |
6.11.2012 |
||
29.10.2012 |
Repso |
|
EU/1/11/674/001-010 |
1.11.2012 |
||
29.10.2012 |
Ribavirin Mylan |
|
EU/1/10/634/001-011 |
1.11.2012 |
||
29.10.2012 |
Rienso |
|
EU/1/12/774/001-004 |
31.10.2012 |
||
29.10.2012 |
Sabervel |
|
EU/1/12/765/001-009 |
31.10.2012 |
||
29.10.2012 |
Samsca |
|
EU/1/09/539/001-004 |
31.10.2012 |
||
29.10.2012 |
Stelara |
|
EU/1/08/494/001-002 |
5.11.2012 |
||
29.10.2012 |
Sycrest |
|
EU/1/10/640/001-006 |
6.11.2012 |
||
29.10.2012 |
Tasmar |
|
EU/1/97/044/001-009 |
1.11.2012 |
||
29.10.2012 |
Telmisartan Actavis |
|
EU/1/10/639/001-030 |
31.10.2012 |
||
29.10.2012 |
Telmisartan Teva |
|
EU/1/09/610/001-062 |
31.10.2012 |
||
29.10.2012 |
Telmisartan Teva Pharma |
|
EU/1/11/719/001-062 |
31.10.2012 |
||
29.10.2012 |
Teysuno |
|
EU/1/11/669/001-005 |
6.11.2012 |
||
29.10.2012 |
Topotecan Hospira |
|
EU/1/10/633/001-002 |
31.10.2012 |
||
29.10.2012 |
Vfend |
|
EU/1/02/212/001-027 |
1.11.2012 |
||
29.10.2012 |
Xarelto |
|
EU/1/08/472/011-021 |
31.10.2012 |
||
29.10.2012 |
Zalasta |
|
EU/1/07/415/001-056 |
6.11.2012 |
||
29.10.2012 |
Zomarist |
|
EU/1/08/483/001-018 |
1.11.2012 |
||
31.10.2012 |
Adjupanrix |
|
EU/1/09/578/001 |
6.11.2012 |
||
31.10.2012 |
Axura |
|
EU/1/02/218/001-003 EU/1/02/218/005-030 |
6.11.2012 |
||
31.10.2012 |
Copalia HCT |
|
EU/1/09/575/001-060 |
6.11.2012 |
||
31.10.2012 |
Dafiro HCT |
|
EU/1/09/574/001-060 |
6.11.2012 |
||
31.10.2012 |
Docetaxel Winthrop |
|
EU/1/07/384/003-005 |
6.11.2012 |
||
31.10.2012 |
Ebixa |
|
EU/1/02/219/001-003 EU/1/02/219/005-049 |
6.11.2012 |
||
31.10.2012 |
Ifirmasta |
|
EU/1/08/480/001-024 |
6.11.2012 |
||
31.10.2012 |
Kaletra |
|
EU/1/01/172/001-008 |
6.11.2012 |
||
31.10.2012 |
Kiovig |
|
EU/1/05/329/001-006 |
6.11.2012 |
||
31.10.2012 |
Levetiracetam Accord |
|
EU/1/11/712/001-040 |
6.11.2012 |
||
31.10.2012 |
Levetiracetam Actavis |
|
EU/1/11/713/001-040 |
6.11.2012 |
||
31.10.2012 |
Ratiograstim |
|
EU/1/08/444/001-012 |
7.11.2012 |
||
31.10.2012 |
Repaglinide Accord |
|
EU/1/11/743/001-015 |
6.11.2012 |
||
31.10.2012 |
Rivastigmine Sandoz |
|
EU/1/09/599/001-018 |
6.11.2012 |
||
31.10.2012 |
Siklos |
|
EU/1/07/397/001-004 |
6.11.2012 |
||
31.10.2012 |
Tevagrastim |
|
EU/1/08/445/001-014 |
6.11.2012 |
||
31.10.2012 |
Tolura |
|
EU/1/10/632/001-021 |
6.11.2012 |
||
31.10.2012 |
Votubia |
|
EU/1/11/710/001-007 |
6.11.2012 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||
4.10.2012 |
Daliresp |
|
— |
8.10.2012 |
||
4.10.2012 |
Daxas |
|
— |
8.10.2012 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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 |
||
24.10.2012 |
Rilonacept Regeneron |
|
EU/1/09/582/001 |
26.10.2012 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||
10.10.2012 |
Acticam |
|
EU/2/08/088/004 |
12.10.2012 |
||
15.10.2012 |
Oxyglobin |
|
EU/2/99/015/001-004 |
16.10.2012 |
||
23.10.2012 |
ProteqFlu |
|
EU/2/03/037/005 |
26.10.2012 |
||
24.10.2012 |
Pirsue |
|
EU/2/00/027/001-003 |
26.10.2012 |
||
25.10.2012 |
Dexdomitor |
|
EU/2/02/033/001-004 |
30.10.2012 |
||
25.10.2012 |
Posatex |
|
EU/2/08/081/001-003 |
29.10.2012 |
||
25.10.2012 |
Stronghold |
|
EU/2/99/014/001-012 |
29.10.2012 |
||
29.10.2012 |
Improvac |
|
EU/2/09/095/001-006 |
1.11.2012 |
||
29.10.2012 |
Loxicom |
|
EU/2/08/090/001-028 |
31.10.2012 |
||
29.10.2012 |
Meloxidyl |
|
EU/2/06/070/009 |
31.10.2012 |
||
29.10.2012 |
Previcox |
|
EU/2/04/045/001-007 |
6.11.2012 |
||
29.10.2012 |
Procox |
|
EU/2/11/123/001-002 |
2.11.2012 |
||
29.10.2012 |
RevitaCAM |
|
EU/2/12/138/001-003 |
31.10.2012 |
||
29.10.2012 |
Suvaxyn PCV |
|
EU/2/09/099/001-006 |
1.11.2012 |
||
31.10.2012 |
PRILACTONE |
|
EU/2/07/074/001-009 |
6.11.2012 |
— Lift of suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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 |
||
10.10.2012 |
Suvaxyn PCV |
|
EU/2/09/099/001-006 |
12.10.2012 |
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 |
UK - LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.