This document is an excerpt from the EUR-Lex website
Document E2012G0216(01)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2011
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2011
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2011
OJ C 44, 16.2.2012, p. 6–20
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
16.2.2012 |
EN |
Official Journal of the European Union |
C 44/6 |
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2011
2012/C 44/05
Subcommittee I on the free movement of goods
To be noted by the EEA Joint Committee
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 January-30 June 2011, at their meeting on 30 September 2011:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
|
Annex V |
List of suspended marketing authorisations |
ANNEX I
List of new marketing authorisations
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2011:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/09/578/001 |
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals |
Iceland |
29.4.2011 |
|
EU/1/10/635/001-014 |
Olanzapin Apotex |
Norway |
14.2.2011 |
|
EU/1/10/639/001-030 |
Telmisartan Actavis |
Norway |
17.3.2011 |
|
EU/1/10/641/001 |
Ruconest |
Iceland |
24.1.2011 |
|
EU/1/10/642/001-004 |
Ibandronic Acid Teva |
Iceland |
17.1.2011 |
|
EU/1/10/647/001-002 |
Myclausen |
Iceland |
21.1.2011 |
|
EU/1/10/647/001-028 |
Twynsta |
Iceland |
21.1.2011 |
|
EU/1/10/650/001-015 |
Clopidogrel Teva Generics BV |
Iceland |
1.2.2011 |
|
EU/1/10/651/001-015 |
Clopidogrel HCS |
Iceland |
1.2.2011 |
|
EU/1/10/654/001-004 |
Leflunomide ratiopharm |
Iceland |
14.3.2011 |
|
EU/1/10/656/001-006 |
Possia |
Iceland |
13.1.2011 |
|
EU/1/10/656/001-006 |
Possia |
Norway |
25.1.2011 |
|
EU/1/10/657/001-002 |
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia |
Iceland |
14.3.2011 |
|
EU/1/10/657/001-002 |
Prepandemic Influenza Vaccine |
Norway |
3.1.2011 |
|
EU/1/10/658/001-002 |
Aflunov |
Iceland |
14.3.2011 |
|
EU/1/10/658/001-002 |
Aflunov |
Norway |
3.1.2011 |
|
EU/1/10/659/001-010 |
Iasibon |
Iceland |
14.2.2011 |
|
EU/1/10/659/001-010 |
Iasibon |
Norway |
17.2.2011 |
|
EU/1/10/659/001-010 |
Iasibon |
Liechtenstein |
28.2.2011 |
|
EU/1/10/660/001-002 |
Potactasol |
Iceland |
16.3.2011 |
|
EU/1/10/660/001-002 |
Potactasol |
Liechtenstein |
28.2.2011 |
|
EU/1/10/661/001-002 |
Fluenz |
Iceland |
16.3.2011 |
|
EU/1/10/661/001-002 |
Fluenz |
Liechtenstein |
28.2.2011 |
|
EU/1/10/662/001-002 |
Docetaxel Teva Pharma |
Iceland |
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 |
Norway |
17.3.2011 |
|
EU/1/10/662/001-002 |
Docetaxel Teva Pharma |
Norway |
17.3.2011 |
|
EU/1/10/663/001-002 |
Lamivudine/Zidovudine Teva |
Norway |
31.3.2011 |
|
EU/1/10/663/001-002 |
Lamivudine/Zidovudine Teva |
Liechtenstein |
30.4.2011 |
|
EU/1/10/664/001 |
Pumarix |
Iceland |
8.4.2011 |
|
EU/1/10/664/001 |
Pumarix |
Norway |
13.4.2011 |
|
EU/1/10/664/001 |
Pumarix |
Liechtenstein |
30.4.2011 |
|
EU/1/10/665/001-004 |
Entacapone Teva |
Iceland |
21.3.2011 |
|
EU/1/10/665/001-004 |
Entacapone Teva |
Norway |
4.4.2011 |
|
EU/1/10/665/001-004 |
Entacapone Teva |
Liechtenstein |
30.4.2011 |
|
EU/1/11/666/001-003 |
Libertek |
Iceland |
24.3.2011 |
|
EU/1/11/666/001-003 |
Libertek |
Norway |
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 |
Iceland |
25.3.2011 |
|
EU/1/11/667/001-003 |
Esbriet |
Norway |
15.3.2011 |
|
EU/1/11/667/001-003 |
Esbriet |
Norway |
15.3.2011 |
|
EU/1/11/668/001-003 |
Daliresp |
Iceland |
12.4.2011 |
|
EU/1/11/668/001-003 |
Daliresp |
Norway |
15.3.2011 |
|
EU/1/11/668/001-003 |
Daliresp |
Liechtenstein |
30.4.2011 |
|
EU/1/11/669/001-004 |
Teysuno |
Iceland |
12.4.2011 |
|
EU/1/11/669/001-004 |
Teysuno |
Norway |
24.5.2011 |
|
EU/1/11/669/001-004 |
Teysuno |
Liechtenstein |
30.4.2011 |
|
EU/1/11/671/001 |
Xiapex |
Iceland |
28.3.2011 |
|
EU/1/11/671/001 |
Xiapex |
Norway |
31.3.2011 |
|
EU/1/11/671/001 |
Xiapex |
Liechtenstein |
30.4.2011 |
|
EU/1/11/672/001-006 |
Xeplion |
Iceland |
8.4.2011 |
|
EU/1/11/672/001-006 |
Xeplion |
Norway |
5.4.2011 |
|
EU/1/11/672/001-006 |
Xeplion |
Liechtenstein |
30.4.2011 |
|
EU/1/11/673/001-024 |
Ifirmacombi |
Iceland |
4.4.2011 |
|
EU/1/11/673/001-024 |
Ifirmacombi |
Norway |
6.4.2011 |
|
EU/1/11/673/001-024 |
Ifirmacombi |
Liechtenstein |
30.4.2011 |
|
EU/1/11/674/001-010 |
Repso |
Iceland |
13.4.2011 |
|
EU/1/11/674/001-010 |
Repso |
Norway |
26.4.2011 |
|
EU/1/11/674/001-010 |
Repso |
Liechtenstein |
30.4.2011 |
|
EU/1/11/675/001-0010 |
Leflunomide Teva |
Iceland |
8.4.2011 |
|
EU/1/11/675/001-010 |
Lefluomide Teva |
Norway |
11.4.2011 |
|
EU/1/11/675/001-010 |
Leflunomid Teva |
Liechtenstein |
30.4.2011 |
|
EU/1/11/676/001 |
Jevtana |
Iceland |
12.4.2011 |
|
EU/1/11/676/001 |
Jevtana |
Norway |
6.4.2011 |
|
EU/1/11/676/001 |
Jevtana |
Liechtenstein |
30.4.2011 |
|
EU/1/11/677/001-004 |
Gilenya |
Iceland |
13.4.2011 |
|
EU/1/11/677/001-004 |
Gilenya |
Norway |
28.3.2011 |
|
EU/1/11/677/001-004 |
Gilenya |
Liechtenstein |
30.4.2011 |
|
EU/1/11/678/001-002 |
Halaven |
Iceland |
14.4.2011 |
|
EU/1/11/678/001-002 |
Halaven |
Norway |
6.4.2011 |
|
EU/1/11/678/001-002 |
Halaven |
Liechtenstein |
30.4.2011 |
|
EU/1/11/679/001-006 |
Pravafenix |
Iceland |
10.5.2011 |
|
EU/1/11/679/001-006 |
Pravafenix |
Norway |
11.5.2011 |
|
EU/1/11/679/001-006 |
Pravafenix |
Liechtenstein |
30.4.2011 |
|
EU/1/11/680/001-080 |
Riprazo HCT |
Iceland |
29.4.2011 |
|
EU/1/11/680/001-080 |
Riprazo HCT |
Norway |
24.5.2011 |
|
EU/1/11/680/001-080 |
Riprazo HCT |
Liechtenstein |
30.4.2011 |
|
EU/1/11/681/001-013 |
Trobalt |
Iceland |
19.4.2011 |
|
EU/1/11/681/001-013 |
Trobalt |
Norway |
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 |
Iceland |
6.6.2011 |
|
EU/1/11/682/001 |
Methylhionininium chloride Proveblue |
Norway |
27.6.2011 |
|
EU/1/11/682/001 |
Methylthioninchlorid Proveblue |
Liechtenstein |
30.6.2011 |
|
EU/1/11/686/001-056 |
Rasilamlo |
Iceland |
12.5.2011 |
|
EU/1/11/686/001-056 |
Rasilamlo |
Norway |
24.5.2011 |
|
EU/1/11/686/001-056 |
Rasilamlo |
Liechtenstein |
30.4.2011 |
|
EU/1/11/687/001-012 |
Hizentra |
Iceland |
12.5.2011 |
|
EU/1/11/687/001-012 |
Hizentra |
Norway |
9.5.2011 |
|
EU/1/11/687/001-012 |
Hizentra |
Liechtenstein |
30.4.2011 |
|
EU/1/11/688/001 |
Cinryze |
Iceland |
28.6.2011 |
|
EU/1/11/688/001 |
Cinryze |
Norway |
27.6.2011 |
|
EU/1/11/691/001-005 |
Eliquis |
Norway |
31.5.2011 |
|
EU/1/11/691/001-005 |
Eliquis |
Liechtenstein |
30.6.2011 |
|
EU/1/11/692/001 |
Yellox |
Iceland |
28.6.2011 |
|
EU/1/11/692/001 |
Yellox |
Norway |
10.6.2011 |
|
EU/1/11/692/001 |
Yellox |
Liechtenstein |
30.6.2011 |
|
EU/1/11/693/001-016 |
Rivastigmine Actavis |
Iceland |
28.6.2011 |
|
EU/1/11/693/001-016 |
Rivastigmine Actavis |
Liechtenstein |
30.6.2011 |
|
EU/1/190/649/001-016 |
Clopidogrel Teva Pharma BV |
Iceland |
30.6.2011 |
|
EU/1/98/058/001-002 |
Lamivudine/Zidovudine Teva |
Iceland |
12.4.2011 |
|
EU/1/98/058/001-002 |
Lamivudine |
Norway |
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 |
Iceland |
10.5.2011 |
|
EU/2/10/107/001-014 |
Veraflox |
Norway |
24.6.2011 |
|
EU/2/10/107/001-014 |
Veraflox |
Liechtenstein |
30.4.2011 |
|
EU/2/10/109/001-009 |
RHINISENG |
Norway |
3.1.2011 |
|
EU/2/10/110/001-002 |
Coxevac |
Iceland |
26.1.2011 |
|
EU/2/10/111/001-004 |
Meloxoral |
Iceland |
14.3.2011 |
|
EU/2/10/111/001-004 |
Meloxoral |
Norway |
3.1.2011 |
|
EU/2/10/112/001-005 |
BTVPUR ALSap 1 |
Iceland |
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 |
Iceland |
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 |
Iceland |
16.3.2011 |
|
EU/2/10/114/001-002 |
Hiprabovis IBR Marker Live |
Norway |
9.2.2011 |
|
EU/2/10/114/001-002 |
Hiprabovis IBR Marker Live |
Liechtenstein |
28.2.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
Iceland |
22.3.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
Norway |
22.2.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
Liechtenstein |
30.4.2011 |
|
EU/2/10/115/001-010 |
Comfortis |
Norway |
22.2.2011 |
|
EU/2/10/116/001-004 |
Melosus |
Iceland |
24.3.2011 |
|
EU/2/10/116/001-004 |
Melosus |
Norway |
14.4.2011 |
|
EU/2/10/116/001-004 |
Melosus |
Liechtenstein |
30.4.2011 |
|
EU/2/10/117/001-002 |
Purevax Rabies |
Iceland |
21.3.2011 |
|
EU/2/10/117/001-002 |
Purevax Rabies |
Norway |
4.4.2011 |
|
EU/2/10/117/001-002 |
Purevax Rabies |
Liechtenstein |
30.4.2011 |
|
EU/2/10/118/001-014 |
Activyl |
Iceland |
21.3.2011 |
|
EU/2/10/118/001-014 |
Activyl |
Norway |
1.4.2011 |
|
EU/2/10/118/001-014 |
Activyl |
Liechtenstein |
30.4.2011 |
|
EU/2/10/119/001-012 |
Cimalgex |
Iceland |
21.3.2011 |
|
EU/2/10/119/001-012 |
Cimalgex |
Norway |
1.4.2011 |
|
EU/2/108/001-005 |
BTVPUR ALSap 2-4 0.72 U.SN |
Iceland |
10.2.2011 |
|
EU/2/11/120/001-003 |
Zulvac 1 + 8 Ovis |
Iceland |
13.4.2011 |
|
EU/2/11/120/001-003 |
Zulvac 1 + 8 Ovis |
Norway |
18.4.2011 |
|
EU/2/11/121/001-009 |
CaniLeish |
Iceland |
13.4.2011 |
|
EU/2/11/121/001-009 |
CaniLeish |
Norway |
11.4.2011 |
|
EU/2/11/121/001-009 |
CaniLeish |
Liechtenstein |
30.4.2011 |
|
EU/2/11/123/001-002 |
Procox |
Iceland |
28.6.2011 |
|
EU/2/11/123/001-002 |
Procox |
Norway |
20.6.2011 |
|
EU/2/11/123/001-002 |
Procox |
Liechtenstein |
30.6.2011 |
|
EU/2/11/124/001-008 |
Zuprevo |
Iceland |
6.6.2011 |
|
EU/2/11/124/001-008 |
Zuprevo |
Liechtenstein |
30.6.2011 |
|
EU/2/11/125/001-008 |
Certifect |
Iceland |
6.6.2011 |
|
EU/2/11/125/001-008 |
Certificet |
Liechtenstein |
30.6.2011 |
|
EU/2/11/126/001 |
MS-H-vaccine |
Iceland |
28.6.2011 |
ANNEX II
List of renewed marketing authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2011:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/00/135/001-002 |
DaTSCAN |
Iceland |
14.3.2011 |
|
EU/1/00/149/001 |
Panretin |
Iceland |
18.1.2011 |
|
EU/1/00/156/002-004 |
Trizivir |
Iceland |
14.2.2011 |
|
EU/1/00/166/001-003 |
NeuroBloc |
Iceland |
15.2.2011 |
|
EU/1/00/166/001-003 |
NeuroBloc |
Norway |
15.2.2011 |
|
EU/1/00/167/001-008 |
Prevenar |
Iceland |
25.3.2011 |
|
EU/1/00/167/001-008 |
Prevenar |
Norway |
3.3.2011 |
|
EU/1/00/167/001-008 |
Prevenar |
Liechtenstein |
28.2.2011 |
|
EU/1/00/173/001-003 |
Vaniqa |
Iceland |
15.4.2011 |
|
EU/1/01/171/001, 007-010, 013-014 |
Rapamune |
Iceland |
21.2.2011 |
|
EU/1/01/171/001, EU/1/01/171/007-010 EU/1/01/171/013-014 |
Rapamune |
Norway |
2.2.2011 |
|
EU/1/01/172/001-008 |
Kaletra |
Iceland |
21.3.2011 |
|
EU/1/01/172/001-008 |
Kaletra |
Norway |
27.4.2011 |
|
EU/1/01/172/001-008 |
Kaletra |
Liechtenstein |
30.4.2011 |
|
EU/1/01/173/001-003 |
Vaniqa |
Norway |
3.5.2011 |
|
EU/1/01/173/001-003 |
Vaniqa |
Liechtenstein |
30.4.2011 |
|
EU/1/01/179/001 |
Osigraft |
Iceland |
17.5.2011 |
|
EU/1/01/179/001 |
Osigraft |
Norway |
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 |
Iceland |
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 |
Norway |
14.4.2011 |
|
EU/1/01/187/001 |
DepoCyte |
Iceland |
23.6.2011 |
|
EU/1/01/187/001 |
DepoCyte |
Liechtenstein |
30.6.2011 |
|
EU/1/01/191/001-005 |
Ketek 400 mg |
Iceland |
9.6.2011 |
|
EU/1/01/191/001-005 |
Ketek |
Norway |
31.5.2011 |
|
EU/1/01/191/001-005 |
Ketek |
Liechtenstein |
30.6.2011 |
|
EU/1/01/193/001-002 |
MabCampath |
Iceland |
23.6.2011 |
|
EU/1/01/193/001-002 |
MabCampath |
Norway |
15.6.2011 |
|
EU/1/05/312/001 |
Xyrem |
Iceland |
14.1.2011 |
|
EU/1/05/313/001-009 |
Ablavar |
Iceland |
28.1.2011 |
|
EU/1/05/314/001 |
Kepivance |
Iceland |
17.1.2011 |
|
EU/1/05/315/001-002 |
Aptivus |
Iceland |
27.1.2011 |
|
EU/1/05/320/001 |
Noxafil |
Iceland |
18.1.2011 |
|
EU/1/05/322/001 |
Yttriga |
Iceland |
18.3.2011 |
|
EU/1/05/322/001 |
Yttriga |
Norway |
20.1.2011 |
|
EU/1/05/322/001 |
Yttriga |
Liechtenstein |
28.2.2011 |
|
EU/1/05/323/001-013 |
ProQuad |
Iceland |
15.4.2011 |
|
EU/1/05/323/001-013 |
ProQuad |
Norway |
6.4.2011 |
|
EU/1/05/323/001-013 |
ProQuad |
Liechtenstein |
30.4.2011 |
|
EU/1/05/324/001-002 |
Naglazyme |
Iceland |
23.3.2011 |
|
EU/1/05/324/001-002 |
Naglazyme |
Norway |
7.2.2011 |
|
EU/1/05/324/001-002 |
Naglazyme |
Liechtenstein |
28.2.2011 |
|
EU/1/05/325/002 |
Macugen |
Iceland |
15.2.2011 |
|
EU/1/05/325/002 |
Macugen |
Norway |
1.2.2011 |
|
EU/1/05/325/002 |
Macugen |
Liechtenstein |
28.2.2011 |
|
EU/1/05/328/001-004 |
Cubicin |
Iceland |
14.2.2011 |
|
EU/1/05/328/001-004 |
Cubicin |
Norway |
11.1.2011 |
|
EU/1/05/329/001-006 |
Kiovig |
Iceland |
24.2.2011 |
|
EU/1/05/329/001-006 |
Kiovig |
Norway |
2.2.2011 |
|
EU/1/05/329/001-006 |
Kiovig |
Liechtenstein |
28.2.2011 |
|
EU/1/05/330/001-011 |
Rotarix |
Iceland |
22.3.2011 |
|
EU/1/05/330/001-011 |
Rotarix |
Norway |
13.5.2011 |
|
EU/1/05/331/001-055 |
Neupro |
Iceland |
15.2.2011 |
|
EU/1/05/331/001-055 |
Neupro |
Norway |
10.1.2011 |
|
EU/1/06/332/001-009 |
Omnitrope |
Iceland |
28.6.2011 |
|
EU/1/06/332/001-009 |
Omnitrope |
Norway |
5.4.2011 |
|
EU/1/06/332/001-009 |
Omnitrope |
Liechtenstein |
30.4.2011 |
|
EU/1/06/333/001-003 |
Myozyme |
Iceland |
20.4.2011 |
|
EU/1/06/333/001-003 |
Myozyme |
Norway |
22.3.2011 |
|
EU/1/06/333/001-003 |
Myozyme |
Liechtenstein |
30.4.2011 |
|
EU/1/06/334/001-005 |
Evoltra |
Iceland |
18.4.2011 |
|
EU/1/06/334/001-005 |
Evoltra |
Norway |
25.5.2011 |
|
EU/1/06/334/001-005 |
Evoltra |
Liechtenstein |
30.4.2011 |
|
EU/1/06/335/001 |
Valtropin |
Iceland |
12.5.2011 |
|
EU/1/06/335/001 |
Valtropin |
Norway |
3.6.2011 |
|
EU/1/06/335/001 |
Valtropin |
Liechtenstein |
30.4.2011 |
|
EU/1/06/336/001 |
Tygacil |
Norway |
31.5.2011 |
|
EU/1/06/336/001 |
Tygacil |
Liechtenstein |
30.6.2011 |
|
EU/1/06/337/001-013 |
M-M-RVAXPRO |
Iceland |
16.5.2011 |
|
EU/1/06/337/001-013 |
M-M-RVAXPRO |
Norway |
31.5.2011 |
|
EU/1/06/337/001-013 |
M-M-RVAXPRO |
Liechtenstein |
30.6.2011 |
|
EU/1/06/338/001-003 |
DuoTrav |
Iceland |
21.1.2011 |
|
EU/1/06/339/001-002 |
Preotact |
Iceland |
11.5.2011 |
|
EU/1/06/339/001-002 |
Preotact |
Liechtenstein |
30.4.2011 |
|
EU/1/06/341/001-013 |
Zostavax |
Iceland |
18.4.2011 |
|
EU/1/06/341/001-013 |
Zostavax |
Liechtenstein |
30.4.2011 |
|
EU/1/06/343/001-007 |
Baraclude |
Iceland |
23.6.2011 |
|
EU/1/06/343/001-007 |
Baraclude |
Liechtenstein |
30.6.2011 |
|
EU/1/06/346/001 |
Tysabri |
Iceland |
27.6.2011 |
|
EU/1/06/348/001-002 |
RotaTeq |
Iceland |
23.6.2011 |
|
EU/1/06/348/001-002 |
RotaTeq |
Norway |
17.6.2011 |
|
EU/1/06/348/001-002 |
RotaTeq |
Liechtenstein |
28.2.2011 |
|
EU/1/06/354/001-011 |
Competact |
Iceland |
24.6.2011 |
|
EU/1/06/354/001-011 |
Competact |
Norway |
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 |
Iceland |
11.2.2011 |
|
EU/1/06/367/001-012 |
Diacomit |
Norway |
15.2.2011 |
|
EU/1/06/367/001-012 |
Diacomit |
Liechtenstein |
28.2.2011 |
|
EU/1/07/423/001-003 |
Vectibix |
Iceland |
15.2.2011 |
|
EU/1/07/423/001-003 |
Vectibix |
Norway |
25.1.2011 |
|
EU/1/07/440/001-003 |
Tyverb |
Norway |
3.6.2011 |
|
EU/1/10/625/001 |
Arzerra |
Iceland |
22.2.2011 |
|
EU/1/10/625/001-002 |
Arzerra |
Norway |
17.2.2011 |
|
EU/1/10/625/001-002 |
Arzerra |
Liechtenstein |
28.2.2011 |
|
EU/1/10/628/001-004 |
Votrient |
Iceland |
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 |
Iceland |
16.5.2011 |
|
EU/1/96/009/001-009 |
Zerit |
Norway |
6.5.2011 |
|
EU/1/96/009/001-009 |
Zerit |
Liechtenstein |
30.4.2011 |
|
EU/2/00/026/001-004 |
Porcilis AR-T DF |
Norway |
3.1.2011 |
|
EU/2/00/026/001-006 |
Porcilis AR-T DF |
Iceland |
17.1.2011 |
|
EU/2/04/045/001-007 |
Previcox |
Norway |
18.4.2011 |
|
EU/2/04/048/001-002 |
Purevax RCP FeLV |
Norway |
13.4.2011 |
|
EU/2/04/049/001-002 |
Purevax RCCh |
Norway |
13.4.2011 |
|
EU/2/04/050/001-002 |
Purevax RCPCh |
Norway |
13.4.2011 |
|
EU/2/04/051/001-002 |
Purevax RC |
Norway |
13.4.2011 |
|
EU/2/04/052/001-002 |
Purevax RCP |
Norway |
13.4.2011 |
|
EU/2/06/058/004 |
Flexicam |
Iceland |
8.4.2011 |
|
EU/2/06/058/004 |
Flexicam |
Norway |
26.4.2011 |
|
EU/2/06/058/004 |
Flexicam |
Liechtenstein |
30.4.2011 |
|
EU/2/06/059/001 |
Convenia |
Iceland |
27.6.2011 |
ANNEX III
List of extended marketing authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2011:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/01/185/100-111 |
Aranesp |
Iceland |
15.4.2011 |
|
EU/1/01/194/003-004 |
INOmax |
Iceland |
15.4.2011 |
|
EU/1/02/227/003 |
Neulasta |
Liechtenstein |
30.4.2011 |
|
EU/1/06/332/010-012 |
Omnitrope |
Iceland |
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 |
Iceland |
25.3.2011 |
|
EU/1/07/397/002-004 |
Siklos |
Norway |
5.4.2011 |
|
EU/1/07/397/002-004 |
Siklos |
Liechtenstein |
30.4.2011 |
|
EU/1/07/401/012-015 |
Alli |
Iceland |
16.2.2011 |
|
EU/1/07/401/012-015 |
Alli |
Norway |
26.1.2011 |
|
EU/1/07/404/006-008 |
Flebogamma DIF |
Iceland |
17.2.2011 |
|
EU/1/07/404/006-008 |
Flebogamma DIF |
Norway |
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 |
Iceland |
20.1.2011 |
|
EU/1/07/420/002 |
Cyanokit |
Norway |
14.2.2011 |
|
EU/1/07/422/005-006 |
Tasigna |
Iceland |
23.3.2011 |
|
EU/1/07/422/005-006 |
Tasigna |
Norway |
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 |
Iceland |
14.4.2011 |
|
EU/1/09/545/011-015 |
Onglyza |
Norway |
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 |
Iceland |
6.6.2011 |
|
EU/1/99/103/005-008 |
ReFacto AF |
Norway |
1.6.2011 |
|
EU/1/99/103/005-008 |
ReFacto AF |
Liechtenstein |
30.6.2011 |
|
EU/2/07/078/009-010 |
Rheumocam |
Iceland |
18.4.2011 |
|
EU/2/07/078/009-010 |
Rheumocam |
Norway |
9.2.2011 |
|
EU/2/07/078/009-010 |
Rheumocam |
Liechtenstein |
28.2.2011 |
|
EU/2/07/078/011-014 |
Rheumocam |
Iceland |
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 |
Iceland |
18.2.2011 |
|
EU/2/98/010/025 |
Econor |
Liechtenstein |
28.2.2011 |
|
EU/99/119/017-018 |
NovoRapid |
Liechtenstein |
30.4.2011 |
ANNEX IV
List of withdrawn marketing authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2011:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/03/259/001-006 |
Onsenal |
Iceland |
20.4.2011 |
|
EU/1/03/259/001-006 |
Onsenal |
Liechtenstein |
30.4.2011 |
|
EU/1/05/326/001 |
Ionsys |
Iceland |
20.4.2011 |
|
EU/1/06/353/001-005 |
Thelin |
Iceland |
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 |
Iceland |
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 |
Iceland |
16.3.2011 |
|
EU/1/09/547/001-007 |
Clopidogrel Sandoz |
Liechtenstein |
30.4.2011 |
|
EU/1/10/629/001 |
Humenza |
Iceland |
29.6.2011 |
|
EU/1/10/629/001 |
Humenza |
Liechtenstein |
30.6.2011 |
ANNEX V
List of suspended marketing authorisations
The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January-30 June 2011:
|
EU-Number |
Product |
Country |
Date of suspension |
|
EU/1/00/137/002-018 |
Avandia |
Iceland |
13.1.2011 |
|
EU/1/03/258/001-022 |
Avandamet |
Iceland |
13.1.2011 |
|
EU/1/06/349/001-010 |
Avaglim |
Iceland |
17.1.2011 |
|
EU/2/06/058/001-003 |
Flexicam |
Iceland |
14.1.2011 |
|
EU/2/08/088/001-003 |
Acticam |
Norway |
7.3.2011 |
|
EU/2/09/099/001-006 |
Suvaxyn PCV |
Iceland |
22.3.2011 |