|
16.2.2012 |
NL |
Publicatieblad van de Europese Unie |
C 44/6 |
Geneesmiddelen — Lijst van door de EER-EVA-staten voor het eerste halfjaar van 2011 afgegeven vergunningen om een geneesmiddel in de handel te brengen
2012/C 44/05
Subcomité I betreffende het vrije verkeer van goederen
Te noteren door het Gemengd Comité van de EER
Met verwijzing naar Besluit nr. 74/1999 van het Gemengd Comité van de EER van 28 mei 1999, wordt het Gemengd Comité van de EER uitgenodigd om op zijn bijeenkomst van 30 september 2011 de navolgende lijsten te noteren betreffende vergunningen om een geneesmiddel in de handel te brengen voor de periode 1 januari-30 juni 2011:
|
Bijlage I |
Lijst van nieuwe vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage II |
Lijst van hernieuwde vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage III |
Lijst van verlengde vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage IV |
Lijst van ingetrokken vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage V |
Lijst van opgeschorte vergunningen om een geneesmiddel in de handel te brengen |
BIJLAGE I
Lijst van nieuwe vergunningen om een geneesmiddel in de handel te brengen
In de EER-EVA-staten zijn in de periode 1 januari-30 juni 2011 de volgende vergunningen om een geneesmiddel in de handel te brengen, afgegeven:
|
EU-nummer |
Product |
Land |
Datum afgifte vergunning |
|
EU/1/09/578/001 |
Pandemic influenza vaccine (H5N1) (gesplitst virion, geïnactiveerd, adjuvant) GlaxoSmithKline Biologicals |
IJsland |
29.4.2011 |
|
EU/1/10/635/001-014 |
Olanzapin Apotex |
Noorwegen |
14.2.2011 |
|
EU/1/10/639/001-030 |
Telmisartan Actavis |
Noorwegen |
17.3.2011 |
|
EU/1/10/641/001 |
Ruconest |
IJsland |
24.1.2011 |
|
EU/1/10/642/001-004 |
Ibandronic Acid Teva |
IJsland |
17.1.2011 |
|
EU/1/10/647/001-002 |
Myclausen |
IJsland |
21.1.2011 |
|
EU/1/10/647/001-028 |
Twynsta |
IJsland |
21.1.2011 |
|
EU/1/10/650/001-015 |
Clopidogrel Teva Generics B.V. |
IJsland |
1.2.2011 |
|
EU/1/10/651/001-015 |
Clopidogrel HCS |
IJsland |
1.2.2011 |
|
EU/1/10/654/001-004 |
Leflunomide ratiopharm |
IJsland |
14.3.2011 |
|
EU/1/10/656/001-006 |
Possia |
IJsland |
13.1.2011 |
|
EU/1/10/656/001-006 |
Possia |
Noorwegen |
25.1.2011 |
|
EU/1/10/657/001-002 |
Prepandemic Influenza vaccine (H5N1) (oppervlakte antigen, geïnactiveerd, adjuvant) Novartis Vaccines and Dia |
IJsland |
14.3.2011 |
|
EU/1/10/657/001-002 |
Prepandemic Influenza Vaccine |
Noorwegen |
3.1.2011 |
|
EU/1/10/658/001-002 |
Aflunov |
IJsland |
14.3.2011 |
|
EU/1/10/658/001-002 |
Aflunov |
Noorwegen |
3.1.2011 |
|
EU/1/10/659/001-010 |
Iasibon |
IJsland |
14.2.2011 |
|
EU/1/10/659/001-010 |
Iasibon |
Noorwegen |
17.2.2011 |
|
EU/1/10/659/001-010 |
Iasibon |
Liechtenstein |
28.2.2011 |
|
EU/1/10/660/001-002 |
Potactasol |
IJsland |
16.3.2011 |
|
EU/1/10/660/001-002 |
Potactasol |
Liechtenstein |
28.2.2011 |
|
EU/1/10/661/001-002 |
Fluenz |
IJsland |
16.3.2011 |
|
EU/1/10/661/001-002 |
Fluenz |
Liechtenstein |
28.2.2011 |
|
EU/1/10/662/001-002 |
Docetaxel Teva Pharma |
IJsland |
17.2.2011 |
|
EU/1/10/662/001-002 |
Docetaxel Teva Pharma |
Liechtenstein |
28.2.2011 |
|
EU/1/10/662/001-002 |
Docetaxel Teva Pharma |
Noorwegen |
17.3.2011 |
|
EU/1/10/662/001-002 |
Docetaxel Teva Pharma |
Noorwegen |
17.3.2011 |
|
EU/1/10/663/001-002 |
Lamivudine/Zidovudine Teva |
Noorwegen |
31.3.2011 |
|
EU/1/10/663/001-002 |
Lamivudine/Zidovudine Teva |
Liechtenstein |
30.4.2011 |
|
EU/1/10/664/001 |
Pumarix |
IJsland |
8.4.2011 |
|
EU/1/10/664/001 |
Pumarix |
Noorwegen |
13.4.2011 |
|
EU/1/10/664/001 |
Pumarix |
Liechtenstein |
30.4.2011 |
|
EU/1/10/665/001-004 |
Entacapone Teva |
IJsland |
21.3.2011 |
|
EU/1/10/665/001-004 |
Entacapone Teva |
Noorwegen |
4.4.2011 |
|
EU/1/10/665/001-004 |
Entacapone Teva |
Liechtenstein |
30.4.2011 |
|
EU/1/11/666/001-003 |
Libertek |
IJsland |
24.3.2011 |
|
EU/1/11/666/001-003 |
Libertek |
Noorwegen |
15.3.2011 |
|
EU/1/11/666/001-003 |
Libertek |
Liechtenstein |
30.4.2011 |
|
EU/1/11/667/001-003 |
Esbriet |
Liechtenstein |
30.4.2011 |
|
EU/1/11/667/001-003 |
Esbriet |
IJsland |
25.3.2011 |
|
EU/1/11/667/001-003 |
Esbriet |
Noorwegen |
15.3.2011 |
|
EU/1/11/667/001-003 |
Esbriet |
Noorwegen |
15.3.2011 |
|
EU/1/11/668/001-003 |
Daliresp |
IJsland |
12.4.2011 |
|
EU/1/11/668/001-003 |
Daliresp |
Noorwegen |
15.3.2011 |
|
EU/1/11/668/001-003 |
Daliresp |
Liechtenstein |
30.4.2011 |
|
EU/1/11/669/001-004 |
Teysuno |
IJsland |
12.4.2011 |
|
EU/1/11/669/001-004 |
Teysuno |
Noorwegen |
24.5.2011 |
|
EU/1/11/669/001-004 |
Teysuno |
Liechtenstein |
30.4.2011 |
|
EU/1/11/671/001 |
Xiapex |
IJsland |
28.3.2011 |
|
EU/1/11/671/001 |
Xiapex |
Noorwegen |
31.3.2011 |
|
EU/1/11/671/001 |
Xiapex |
Liechtenstein |
30.4.2011 |
|
EU/1/11/672/001-006 |
Xeplion |
IJsland |
8.4.2011 |
|
EU/1/11/672/001-006 |
Xeplion |
Noorwegen |
5.4.2011 |
|
EU/1/11/672/001-006 |
Xeplion |
Liechtenstein |
30.4.2011 |
|
EU/1/11/673/001-024 |
Ifirmacombi |
IJsland |
4.4.2011 |
|
EU/1/11/673/001-024 |
Ifirmacombi |
Noorwegen |
6.4.2011 |
|
EU/1/11/673/001-024 |
Ifirmacombi |
Liechtenstein |
30.4.2011 |
|
EU/1/11/674/001-010 |
Repso |
IJsland |
13.4.2011 |
|
EU/1/11/674/001-010 |
Repso |
Noorwegen |
26.4.2011 |
|
EU/1/11/674/001-010 |
Repso |
Liechtenstein |
30.4.2011 |
|
EU/1/11/675/001-0010 |
Leflunomide Teva |
IJsland |
8.4.2011 |
|
EU/1/11/675/001-010 |
Lefluomide Teva |
Noorwegen |
11.4.2011 |
|
EU/1/11/675/001-010 |
Leflunomid Teva |
Liechtenstein |
30.4.2011 |
|
EU/1/11/676/001 |
Jevtana |
IJsland |
12.4.2011 |
|
EU/1/11/676/001 |
Jevtana |
Noorwegen |
6.4.2011 |
|
EU/1/11/676/001 |
Jevtana |
Liechtenstein |
30.4.2011 |
|
EU/1/11/677/001-004 |
Gilenya |
IJsland |
13.4.2011 |
|
EU/1/11/677/001-004 |
Gilenya |
Noorwegen |
28.3.2011 |
|
EU/1/11/677/001-004 |
Gilenya |
Liechtenstein |
30.4.2011 |
|
EU/1/11/678/001-002 |
Halaven |
IJsland |
14.4.2011 |
|
EU/1/11/678/001-002 |
Halaven |
Noorwegen |
6.4.2011 |
|
EU/1/11/678/001-002 |
Halaven |
Liechtenstein |
30.4.2011 |
|
EU/1/11/679/001-006 |
Pravafenix |
IJsland |
10.5.2011 |
|
EU/1/11/679/001-006 |
Pravafenix |
Noorwegen |
11.5.2011 |
|
EU/1/11/679/001-006 |
Pravafenix |
Liechtenstein |
30.4.2011 |
|
EU/1/11/680/001-080 |
Riprazo HCT |
IJsland |
29.4.2011 |
|
EU/1/11/680/001-080 |
Riprazo HCT |
Noorwegen |
24.5.2011 |
|
EU/1/11/680/001-080 |
Riprazo HCT |
Liechtenstein |
30.4.2011 |
|
EU/1/11/681/001-013 |
Trobalt |
IJsland |
19.4.2011 |
|
EU/1/11/681/001-013 |
Trobalt |
Noorwegen |
4.4.2011 |
|
EU/1/11/681/001-013 |
Trobalt |
Liechtenstein |
30.6.2011 |
|
EU/1/11/681/001-013 |
Trobalt |
Liechtenstein |
30.4.2011 |
|
EU/1/11/682/001 |
Methylthioninium chloride Proveblue |
IJsland |
6.6.2011 |
|
EU/1/11/682/001 |
Methylhionininium chloride Proveblue |
Noorwegen |
27.6.2011 |
|
EU/1/11/682/001 |
Methylthioninchlorid Proveblue |
Liechtenstein |
30.6.2011 |
|
EU/1/11/686/001-056 |
Rasilamlo |
IJsland |
12.5.2011 |
|
EU/1/11/686/001-056 |
Rasilamlo |
Noorwegen |
24.5.2011 |
|
EU/1/11/686/001-056 |
Rasilamlo |
Liechtenstein |
30.4.2011 |
|
EU/1/11/687/001-012 |
Hizentra |
IJsland |
12.5.2011 |
|
EU/1/11/687/001-012 |
Hizentra |
Noorwegen |
9.5.2011 |
|
EU/1/11/687/001-012 |
Hizentra |
Liechtenstein |
30.4.2011 |
|
EU/1/11/688/001 |
Cinryze |
IJsland |
28.6.2011 |
|
EU/1/11/688/001 |
Cinryze |
Noorwegen |
27.6.2011 |
|
EU/1/11/691/001-005 |
Eliquis |
Noorwegen |
31.5.2011 |
|
EU/1/11/691/001-005 |
Eliquis |
Liechtenstein |
30.6.2011 |
|
EU/1/11/692/001 |
Yellox |
IJsland |
28.6.2011 |
|
EU/1/11/692/001 |
Yellox |
Noorwegen |
10.6.2011 |
|
EU/1/11/692/001 |
Yellox |
Liechtenstein |
30.6.2011 |
|
EU/1/11/693/001-016 |
Rivastigmine Actavis |
IJsland |
28.6.2011 |
|
EU/1/11/693/001-016 |
Rivastigmine Actavis |
Liechtenstein |
30.6.2011 |
|
EU/1/190/649/001-016 |
Clopidogrel Teva Pharma B.V. |
IJsland |
30.6.2011 |
|
EU/1/98/058/001-002 |
Lamivudine/Zidovudine Teva |
IJsland |
12.4.2011 |
|
EU/1/98/058/001-002 |
Lamivudine |
Noorwegen |
31.3.2011 |
|
EU/2/11/120/001-003 |
Zulvac 1 + 8 Ovis |
Liechtenstein |
30.4.2011 |
|
EU/2/11/126/001 |
MS-H Impfstoff |
Liechtenstein |
30.6.2011 |
|
EU/2/10/107/001-014 |
Veraflox |
IJsland |
10.5.2011 |
|
EU/2/10/107/001-014 |
Veraflox |
Noorwegen |
24.6.2011 |
|
EU/2/10/107/001-014 |
Veraflox |
Liechtenstein |
30.4.2011 |
|
EU/2/10/109/001-009 |
RHINISENG |
Noorwegen |
3.1.2011 |
|
EU/2/10/110/001-002 |
Coxevac |
IJsland |
26.1.2011 |
|
EU/2/10/111/001-004 |
Meloxoral |
IJsland |
14.3.2011 |
|
EU/2/10/111/001-004 |
Meloxoral |
Noorwegen |
3.1.2011 |
|
EU/2/10/112/001-005 |
BTVPUR ALSap 1 |
IJsland |
10.2.2011 |
|
EU/2/10/112/001-005 |
BTVPUR ALSap 1 |
Liechtenstein |
28.2.2011 |
|
EU/2/10/113/001-005 |
BTVPUR ALSap 1-8 |
IJsland |
10.2.2011 |
|
EU/2/10/113/001-005 |
BTVPUR ALSap 1-8 |
Liechtenstein |
28.2.2011 |
|
EU/2/10/114/001-002 |
Hiprabovis IBR Marker Live |
IJsland |
16.3.2011 |
|
EU/2/10/114/001-002 |
Hiprabovis IBR Marker Live |
Noorwegen |
9.2.2011 |
|
EU/2/10/114/001-002 |
Hiprabovis IBR Marker Live |
Liechtenstein |
28.2.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
IJsland |
22.3.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
Noorwegen |
22.2.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
Liechtenstein |
30.4.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
Noorwegen |
22.2.2011 |
|
EU/2/10/116/001-004 |
Melosus |
IJsland |
24.3.2011 |
|
EU/2/10/116/001-004 |
Melosus |
Noorwegen |
14.4.2011 |
|
EU/2/10/116/001-004 |
Melosus |
Liechtenstein |
30.4.2011 |
|
EU/2/10/117/001-002 |
Purevax Rabies |
IJsland |
21.3.2011 |
|
EU/2/10/117/001-002 |
Purevax Rabies |
Noorwegen |
4.4.2011 |
|
EU/2/10/117/001-002 |
Purevax Rabies |
Liechtenstein |
30.4.2011 |
|
EU/2/10/118/001-014 |
Activyl |
IJsland |
21.3.2011 |
|
EU/2/10/118/001-014 |
Activyl |
Noorwegen |
1.4.2011 |
|
EU/2/10/118/001-014 |
Activyl |
Liechtenstein |
30.4.2011 |
|
EU/2/10/119/001-012 |
Cimalgex |
IJsland |
21.3.2011 |
|
EU/2/10/119/001-012 |
Cimalgex |
Noorwegen |
1.4.2011 |
|
EU/2/108/001-005 |
BTVPUR ALSap 2-4 0.72 U.SN |
IJsland |
10.2.2011 |
|
EU/2/11/120/001-003 |
Zulvac 1 + 8 Ovis |
IJsland |
13.4.2011 |
|
EU/2/11/120/001-003 |
Zulvac 1 + 8 Ovis |
Noorwegen |
18.4.2011 |
|
EU/2/11/121/001-009 |
CaniLeish |
IJsland |
13.4.2011 |
|
EU/2/11/121/001-009 |
CaniLeish |
Noorwegen |
11.4.2011 |
|
EU/2/11/121/001-009 |
CaniLeish |
Liechtenstein |
30.4.2011 |
|
EU/2/11/123/001-002 |
Procox |
IJsland |
28.6.2011 |
|
EU/2/11/123/001-002 |
Procox |
Noorwegen |
20.6.2011 |
|
EU/2/11/123/001-002 |
Procox |
Liechtenstein |
30.6.2011 |
|
EU/2/11/124/001-008 |
Zuprevo |
IJsland |
6.6.2011 |
|
EU/2/11/124/001-008 |
Zuprevo |
Liechtenstein |
30.6.2011 |
|
EU/2/11/125/001-008 |
Certifect |
IJsland |
6.6.2011 |
|
EU/2/11/125/001-008 |
Certificet |
Liechtenstein |
30.6.2011 |
|
EU/2/11/126/001 |
MS-H-vaccine |
IJsland |
28.6.2011 |
BIJLAGE II
Lijst van hernieuwde vergunningen om een geneesmiddel in de handel te brengen
In de EER-EVA-staten zijn in de periode 1 januari-30 juni 2011 de volgende hernieuwde vergunningen om een geneesmiddel in de handel te brengen, afgegeven:
|
EU-nummer |
Product |
Land |
Datum afgifte hernieuwing |
|
EU/1/00/135/001-002 |
DaTSCAN |
IJsland |
14.3.2011 |
|
EU/1/00/149/001 |
Panretin |
IJsland |
18.1.2011 |
|
EU/1/00/156/002-004 |
Trizivir |
IJsland |
14.2.2011 |
|
EU/1/00/166/001-003 |
NeuroBloc |
IJsland |
15.2.2011 |
|
EU/1/00/166/001-003 |
NeuroBloc |
Noorwegen |
15.2.2011 |
|
EU/1/00/167/001-008 |
Prevenar |
IJsland |
25.3.2011 |
|
EU/1/00/167/001-008 |
Prevenar |
Noorwegen |
3.3.2011 |
|
EU/1/00/167/001-008 |
Prevenar |
Liechtenstein |
28.2.2011 |
|
EU/1/00/173/001-003 |
Vaniqa |
IJsland |
15.4.2011 |
|
EU/1/01/171/001, 007-010, 013-014 |
Rapamune |
IJsland |
21.2.2011 |
|
EU/1/01/171/001, EU/1/01/171/007-010 EU/1/01/171/013-014 |
Rapamune |
Noorwegen |
2.2.2011 |
|
EU/1/01/172/001-008 |
Kaletra |
IJsland |
21.3.2011 |
|
EU/1/01/172/001-008 |
Kaletra |
Noorwegen |
27.4.2011 |
|
EU/1/01/172/001-008 |
Kaletra |
Liechtenstein |
30.4.2011 |
|
EU/1/01/173/001-003 |
Vaniqa |
Noorwegen |
3.5.2011 |
|
EU/1/01/173/001-003 |
Vaniqa |
Liechtenstein |
30.4.2011 |
|
EU/1/01/179/001 |
Osigraft |
IJsland |
17.5.2011 |
|
EU/1/01/179/001 |
Osigraft |
Noorwegen |
15.6.2011 |
|
EU/1/01/179/001 |
Osigraft |
Liechtenstein |
30.6.2011 |
|
EU/1/01/183/001&004-005, 007-008, 011, 013, 015, 018-032 |
HBVAXPRO |
IJsland |
18.4.2011 |
|
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/1/01/183/018-032 |
HBVAXPRO |
Noorwegen |
14.4.2011 |
|
EU/1/01/187/001 |
DepoCyte |
IJsland |
23.6.2011 |
|
EU/1/01/187/001 |
DepoCyte |
Liechtenstein |
30.6.2011 |
|
EU/1/01/191/001-005 |
Ketek 400 mg |
IJsland |
9.6.2011 |
|
EU/1/01/191/001-005 |
Ketek |
Noorwegen |
31.5.2011 |
|
EU/1/01/191/001-005 |
Ketek |
Liechtenstein |
30.6.2011 |
|
EU/1/01/193/001-002 |
MabCampath |
IJsland |
23.6.2011 |
|
EU/1/01/193/001-002 |
MabCampath |
Noorwegen |
15.6.2011 |
|
EU/1/05/312/001 |
Xyrem |
IJsland |
14.1.2011 |
|
EU/1/05/313/001-009 |
Ablavar |
IJsland |
28.1.2011 |
|
EU/1/05/314/001 |
Kepivance |
IJsland |
17.1.2011 |
|
EU/1/05/315/001-002 |
Aptivus |
IJsland |
27.1.2011 |
|
EU/1/05/320/001 |
Noxafil |
IJsland |
18.1.2011 |
|
EU/1/05/322/001 |
Yttriga |
IJsland |
18.3.2011 |
|
EU/1/05/322/001 |
Yttriga |
Noorwegen |
20.1.2011 |
|
EU/1/05/322/001 |
Yttriga |
Liechtenstein |
28.2.2011 |
|
EU/1/05/323/001-013 |
ProQuad |
IJsland |
15.4.2011 |
|
EU/1/05/323/001-013 |
ProQuad |
Noorwegen |
6.4.2011 |
|
EU/1/05/323/001-013 |
ProQuad |
Liechtenstein |
30.4.2011 |
|
EU/1/05/324/001-002 |
Naglazyme |
IJsland |
23.3.2011 |
|
EU/1/05/324/001-002 |
Naglazyme |
Noorwegen |
7.2.2011 |
|
EU/1/05/324/001-002 |
Naglazyme |
Liechtenstein |
28.2.2011 |
|
EU/1/05/325/002 |
Macugen |
IJsland |
15.2.2011 |
|
EU/1/05/325/002 |
Macugen |
Noorwegen |
1.2.2011 |
|
EU/1/05/325/002 |
Macugen |
Liechtenstein |
28.2.2011 |
|
EU/1/05/328/001-004 |
Cubicin |
IJsland |
14.2.2011 |
|
EU/1/05/328/001-004 |
Cubicin |
Noorwegen |
11.1.2011 |
|
EU/1/05/329/001-006 |
Kiovig |
IJsland |
24.2.2011 |
|
EU/1/05/329/001-006 |
Kiovig |
Noorwegen |
2.2.2011 |
|
EU/1/05/329/001-006 |
Kiovig |
Liechtenstein |
28.2.2011 |
|
EU/1/05/330/001-011 |
Rotarix |
IJsland |
22.3.2011 |
|
EU/1/05/330/001-011 |
Rotarix |
Noorwegen |
13.5.2011 |
|
EU/1/05/331/001-055 |
Neupro |
IJsland |
15.2.2011 |
|
EU/1/05/331/001-055 |
Neupro |
Noorwegen |
10.1.2011 |
|
EU/1/06/332/001-009 |
Omnitrope |
IJsland |
28.6.2011 |
|
EU/1/06/332/001-009 |
Omnitrope |
Noorwegen |
5.4.2011 |
|
EU/1/06/332/001-009 |
Omnitrope |
Liechtenstein |
30.4.2011 |
|
EU/1/06/333/001-003 |
Myozyme |
IJsland |
20.4.2011 |
|
EU/1/06/333/001-003 |
Myozyme |
Noorwegen |
22.3.2011 |
|
EU/1/06/333/001-003 |
Myozyme |
Liechtenstein |
30.4.2011 |
|
EU/1/06/334/001-005 |
Evoltra |
IJsland |
18.4.2011 |
|
EU/1/06/334/001-005 |
Evoltra |
Noorwegen |
25.5.2011 |
|
EU/1/06/334/001-005 |
Evoltra |
Liechtenstein |
30.4.2011 |
|
EU/1/06/335/001 |
Valtropin |
IJsland |
12.5.2011 |
|
EU/1/06/335/001 |
Valtropin |
Noorwegen |
3.6.2011 |
|
EU/1/06/335/001 |
Valtropin |
Liechtenstein |
30.4.2011 |
|
EU/1/06/336/001 |
Tygacil |
Noorwegen |
31.5.2011 |
|
EU/1/06/336/001 |
Tygacil |
Liechtenstein |
30.6.2011 |
|
EU/1/06/337/001-013 |
M-M-RVAXPRO |
IJsland |
16.5.2011 |
|
EU/1/06/337/001-013 |
M-M-RVAXPRO |
Noorwegen |
31.5.2011 |
|
EU/1/06/337/001-013 |
M-M-RVAXPRO |
Liechtenstein |
30.6.2011 |
|
EU/1/06/338/001-003 |
DuoTrav |
IJsland |
21.1.2011 |
|
EU/1/06/339/001-002 |
Preotact |
IJsland |
11.5.2011 |
|
EU/1/06/339/001-002 |
Preotact |
Liechtenstein |
30.4.2011 |
|
EU/1/06/341/001-013 |
Zostavax |
IJsland |
18.4.2011 |
|
EU/1/06/341/001-013 |
Zostavax |
Liechtenstein |
30.4.2011 |
|
EU/1/06/343/001-007 |
Baraclude |
IJsland |
23.6.2011 |
|
EU/1/06/343/001-007 |
Baraclude |
Liechtenstein |
30.6.2011 |
|
EU/1/06/346/001 |
Tysabri |
IJsland |
27.6.2011 |
|
EU/1/06/348/001-002 |
RotaTeq |
IJsland |
23.6.2011 |
|
EU/1/06/348/001-002 |
RotaTeq |
Noorwegen |
17.6.2011 |
|
EU/1/06/348/001-002 |
RotaTeq |
Liechtenstein |
28.2.2011 |
|
EU/1/06/354/001-011 |
Competact |
IJsland |
24.6.2011 |
|
EU/1/06/354/001-011 |
Competact |
Noorwegen |
23.6.2011 |
|
EU/1/06/354/001-011 |
Competact |
Liechtenstein |
30.6.2011 |
|
EU/1/06/360/001-013 |
Champix |
Liechtenstein |
30.6.2011 |
|
EU/1/06/367/001-012 |
Diacomit |
IJsland |
11.2.2011 |
|
EU/1/06/367/001-012 |
Diacomit |
Noorwegen |
15.2.2011 |
|
EU/1/06/367/001-012 |
Diacomit |
Liechtenstein |
28.2.2011 |
|
EU/1/07/423/001-003 |
Vectibix |
IJsland |
15.2.2011 |
|
EU/1/07/423/001-003 |
Vectibix |
Noorwegen |
25.1.2011 |
|
EU/1/07/440/001-003 |
Tyverb |
Noorwegen |
3.6.2011 |
|
EU/1/10/625/001 |
Arzerra |
IJsland |
22.2.2011 |
|
EU/1/10/625/001-002 |
Arzerra |
Noorwegen |
17.2.2011 |
|
EU/1/10/625/001-002 |
Arzerra |
Liechtenstein |
28.2.2011 |
|
EU/1/10/628/001-004 |
Votrient |
IJsland |
6.6.2011 |
|
EU/1/183/001, 004-005, 007-008, 011, 013, 015, 018-032 |
HBVAXPRO |
Liechtenstein |
30.4.2011 |
|
EU/1/96/009/001-008 |
Zerit |
IJsland |
16.5.2011 |
|
EU/1/96/009/001-009 |
Zerit |
Noorwegen |
6.5.2011 |
|
EU/1/96/009/001-009 |
Zerit |
Liechtenstein |
30.4.2011 |
|
EU/2/00/026/001-004 |
Porcilis AR-T DF |
Noorwegen |
3.1.2011 |
|
EU/2/00/026/001-006 |
Porcilis AR-T DF |
IJsland |
17.1.2011 |
|
EU/2/04/045/001-007 |
Previcox |
Noorwegen |
18.4.2011 |
|
EU/2/04/048/001-002 |
Purevax RCP FeLV |
Noorwegen |
13.4.2011 |
|
EU/2/04/049/001-002 |
Purevax RCCh |
Noorwegen |
13.4.2011 |
|
EU/2/04/050/001-002 |
Purevax RCPCh |
Noorwegen |
13.4.2011 |
|
EU/2/04/051/001-002 |
Purevax RC |
Noorwegen |
13.4.2011 |
|
EU/2/04/052/001-002 |
Purevax RCP |
Noorwegen |
13.4.2011 |
|
EU/2/06/058/004 |
Flexicam |
IJsland |
8.4.2011 |
|
EU/2/06/058/004 |
Flexicam |
Noorwegen |
26.4.2011 |
|
EU/2/06/058/004 |
Flexicam |
Liechtenstein |
30.4.2011 |
|
EU/2/06/059/001 |
Convenia |
IJsland |
27.6.2011 |
BIJLAGE III
Lijst van verlengde vergunningen om een geneesmiddel in de handel te brengen
In de EER-EVA-staten zijn in de periode 1 januari-30 juni 2011 de volgende vergunningen om een geneesmiddel in de handel te brengen, verlengd:
|
EU-nummer |
Product |
Land |
Datum afgifte verlenging |
|
EU/1/01/185/100-111 |
Aranesp |
IJsland |
15.4.2011 |
|
EU/1/01/194/003-004 |
INOmax |
IJsland |
15.4.2011 |
|
EU/1/02/227/003 |
Neulasta |
Liechtenstein |
30.4.2011 |
|
EU/1/06/332/010-012 |
Omnitrope |
IJsland |
16.6.2011 |
|
EU/1/06/332/010-012 |
Omnitrope |
Liechtenstein |
30.6.2011 |
|
EU/1/06/354/010-011 |
Competact |
Liechtenstein |
28.2.2011 |
|
EU/1/06/354/012 |
Competact |
Liechtenstein |
30.6.2011 |
|
EU/1/06/370/037-039 |
Exforge |
Liechtenstein |
28.2.2011 |
|
EU/1/06/371/037-039 |
Dafiro |
Liechtenstein |
28.2.2011 |
|
EU/1/06/373/037-039 |
Imprida |
Liechtenstein |
28.2.2011 |
|
EU/1/07/387/014-026 |
Advagraf |
Liechtenstein |
30.6.2011 |
|
EU/1/07/397/002-004 |
Siklos |
IJsland |
25.3.2011 |
|
EU/1/07/397/002-004 |
Siklos |
Noorwegen |
5.4.2011 |
|
EU/1/07/397/002-004 |
Siklos |
Liechtenstein |
30.4.2011 |
|
EU/1/07/401/012-015 |
Alli |
IJsland |
16.2.2011 |
|
EU/1/07/401/012-015 |
Alli |
Noorwegen |
26.1.2011 |
|
EU/1/07/404/006-008 |
Flebogamma DIF |
IJsland |
17.2.2011 |
|
EU/1/07/404/006-008 |
Flebogamma DIF |
Noorwegen |
14.1.2011 |
|
EU/1/07/404/006-008 |
Flebogamma DIF |
Liechtenstein |
28.2.2011 |
|
EU/1/07/407/021-040 |
Sprimeo |
Liechtenstein |
30.4.2011 |
|
EU/1/07/410/027-052 |
Binocrit |
Liechtenstein |
30.4.2011 |
|
EU/1/07/411/027-052 |
Epoetin alfa Hexal |
Liechtenstein |
30.4.2011 |
|
EU/1/07/420/002 |
Cyanokit |
IJsland |
20.1.2011 |
|
EU/1/07/420/002 |
Cyanokit |
Noorwegen |
14.2.2011 |
|
EU/1/07/422/005-006 |
Tasigna |
IJsland |
23.3.2011 |
|
EU/1/07/422/005-006 |
Tasigna |
Noorwegen |
21.1.2011 |
|
EU/1/07/422/005-006 |
Tasigna |
Liechtenstein |
28.2.2011 |
|
EU/1/07/438/005-006 |
Myfenax |
Liechtenstein |
30.6.2011 |
|
EU/1/07/439/005-006 |
Mycophenole mofetil Teva |
Liechtenstein |
30.6.2011 |
|
EU/1/08/461/002 |
Firazyr |
Liechtenstein |
30.4.2011 |
|
EU/1/08/490/017-024 |
Pramipexole Teva |
Liechtenstein |
30.6.2011 |
|
EU/1/09/511/005 |
Conbriza |
Liechtenstein |
30.4.2011 |
|
EU/1/09/535/015-016 |
Grepid |
Liechtenstein |
28.2.2011 |
|
EU/1/09/545/011-015 |
Onglyza |
IJsland |
14.4.2011 |
|
EU/1/09/545/011-015 |
Onglyza |
Noorwegen |
25.3.2011 |
|
EU/1/09/545/011-015 |
Onglyza |
Liechtenstein |
30.4.2011 |
|
EU/1/09/581/003-008 |
Resolor |
Liechtenstein |
28.2.2011 |
|
EU/1/10/614/002 |
Menveo |
Liechtenstein |
30.4.2011 |
|
EU/1/96/022/035-040 |
Zyprexa |
Liechtenstein |
28.2.2011 |
|
EU/1/97/033/005-006 |
Avonex |
Liechtenstein |
30.6.2011 |
|
EU/1/99/103/005 |
ReFacto AF |
IJsland |
6.6.2011 |
|
EU/1/99/103/005-008 |
ReFacto AF |
Noorwegen |
1.6.2011 |
|
EU/1/99/103/005-008 |
ReFacto AF |
Liechtenstein |
30.6.2011 |
|
EU/2/07/078/009-010 |
Rheumocam |
IJsland |
18.4.2011 |
|
EU/2/07/078/009-010 |
Rheumocam |
Noorwegen |
9.2.2011 |
|
EU/2/07/078/009-010 |
Rheumocam |
Liechtenstein |
28.2.2011 |
|
EU/2/07/078/011-014 |
Rheumocam |
IJsland |
28.6.2011 |
|
EU/2/07/078/011-014 |
Rheumocam |
Liechtenstein |
30.6.2011 |
|
EU/2/08/082/007 |
Zactran |
Liechtenstein |
30.6.2011 |
|
EU/2/97/004/041-048 |
Metacam |
Liechtenstein |
28.2.2011 |
|
EU/2/98/010/025 |
Econor |
IJsland |
18.2.2011 |
|
EU/2/98/010/025 |
Econor |
Liechtenstein |
28.2.2011 |
|
EU/99/119/017-018 |
NovoRapid |
Liechtenstein |
30.4.2011 |
BIJLAGE IV
Lijst van ingetrokken vergunningen om een geneesmiddel in de handel te brengen
In de EER-EVA-staten zijn in de periode 1 januari-30 juni 2011 de volgende vergunningen om een geneesmiddel in de handel te brengen, ingetrokken:
|
EU-nummer |
Product |
Land |
Datum van intrekking |
|
EU/1/03/259/001-006 |
Onsenal |
IJsland |
20.4.2011 |
|
EU/1/03/259/001-006 |
Onsenal |
Liechtenstein |
30.4.2011 |
|
EU/1/05/326/001 |
Ionsys |
IJsland |
20.4.2011 |
|
EU/1/06/353/001-005 |
Thelin |
IJsland |
15.3.2011 |
|
EU/1/06/353/001-005 |
Thelin |
Liechtenstein |
28.2.2011 |
|
EU/1/08/449/001-008 |
Filgrastim ratiopharm |
Liechtenstein |
30.4.2011 |
|
EU/1/08/449/001-008 |
Filgrastim ratiopharm |
IJsland |
12.5.2011 |
|
EU/1/09/542/001-007 |
Clopidogrel 1A Pharma |
Liechtenstein |
28.2.2011 |
|
EU/1/09/542/001-007 |
Clopidogrel 1A Pharma |
IJsland |
16.3.2011 |
|
EU/1/09/547/001-007 |
Clopidogrel Sandoz |
Liechtenstein |
30.4.2011 |
|
EU/1/10/629/001 |
Humenza |
IJsland |
29.6.2011 |
|
EU/1/10/629/001 |
Humenza |
Liechtenstein |
30.6.2011 |
BIJLAGE V
Lijst van opgeschorte vergunningen om een geneesmiddel in de handel te brengen
In de EER-EVA-staten zijn in de periode 1 januari-30 juni 2011 de volgende vergunningen om een geneesmiddel in de handel te brengen, opgeschort:
|
EU-nummer |
Product |
Land |
Datum van opschorting |
|
EU/1/00/137/002-018 |
Avandia |
IJsland |
13.1.2011 |
|
EU/1/03/258/001-022 |
Avandamet |
IJsland |
13.1.2011 |
|
EU/1/06/349/001-010 |
Avaglim |
IJsland |
17.1.2011 |
|
EU/2/06/058/001-003 |
Flexicam |
IJsland |
14.1.2011 |
|
EU/2/08/088/001-003 |
Acticam |
Noorwegen |
7.3.2011 |
|
EU/2/09/099/001-006 |
Suvaxyn PCV |
IJsland |
22.3.2011 |