Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2010
Date: 2011-10-13
Institutions: Standing Committee of the EFTA States
Subjects: EFTA countries, European Economic Area, free movement of goods, market approval, medicinal product








C_2011302EN.01002201.xml










13.10.2011   


EN


Official Journal of the European Union


C 302/22





Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2010
2011/C 302/06

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 July-31 December 2010, at their meeting on 1 April 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List of withdrawn marketing authorisations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 July-31 December 2010:








EU-Number


Product


Country


Date of authorisation




EU/1/09/605/001/NO-012/NO


Temomedac


Norway


8.7.2010




EU/1/10/626/001-004


Ribavirin BioPartners


Liechtenstein


31.8.2010




EU/1/10/629/001/NO


Humenza


Norway


17.8.2010




EU/1/10/631/001/NO-009/NO


Nivestim


Norway


15.9.2010




EU/1/10/631/001-009/IS


Nivestim


Iceland


27.8.2010




EU/1/10/632/001/NO-021/NO


Tolura


Norway


26.8.2010




EU/1/10/632/001-021/IS


Tolura


Iceland


2.7.2010




EU/1/10/633/001-002/IS


Topotecan Hospira


Iceland


1.9.2010




EU/1/10/634/001/NO-004/NO


Ribavirin Three Rivers


Norway


19.8.2010




EU/1/10/636/001/NO-003/NO


Daxas


Norway


12.8.2010




EU/1/10/636/001-003


Daxas


Liechtenstein


31.8.2010




EU/1/10/636/001-003/IS


Daxas


Iceland


3.8.2010




EU/1/10/637/001/NO-009/NO


Leflunomide medac


Norway


25.8.2010




EU/1/10/637/001-009


Leflunomide medac


Liechtenstein


31.10.2010




EU/1/10/637/001-009/IS


Leflunomide medac


Iceland


26.8.2010




EU/1/10/638/001


Ozurdex


Liechtenstein


31.8.2010




EU/1/10/638/001/IS


Ozurdex


Iceland


26.8.2010




EU/1/10/638/001/NO


Ozurdex


Norway


8.10.2010




EU/1/10/639/001-030


Telmisartan Actavis


Liechtenstein


31.12.2010




EU/1/10/639/001-030/IS


Telmisartan Actavis


Iceland


15.12.2010




EU/1/10/640/001/NO-006/NO


Sycrest


Norway


15.11.2010




EU/1/10/640/001-006


Sycrest


Liechtenstein


31.10.2010




EU/1/10/640/001-006/IS


Sycrest


Iceland


23.9.2010




EU/1/10/641/001/NO


Ruconest


Norway


2.12.2010




EU/1/10/642/001-004


Ibandronic acid


Liechtenstein


31.10.2010




EU/1/10/643/001


Rapiscan


Liechtenstein


31.10.2010




EU/1/10/643/001/IS


Rapiscan


Iceland


26.10.2010




EU/1/10/643/001/NO


Rapiscan


Norway


27.9.2010




EU/1/10/644/001/NO-004/NO


PecFent


Norway


15.9.2010




EU/1/10/644/001-004


PecFent


Liechtenstein


31.10.2010




EU/1/10/644/001-004/IS


PecFent


Iceland


29.9.2010




EU/1/10/645/001/NO-002/NO


Brinavess


Norway


28.9.2010




EU/1/10/645/001-002


Brinavess


Liechtenstein


31.10.2010




EU/1/10/645/001-002/IS


Brinavess


Iceland


23.9.2010




EU/1/10/646/001/NO-002/NO


VPRIV


Norway


2.11.2010




EU/1/10/646/001-002


VPRIV


Liechtenstein


31.10.2010




EU/1/10/646/001-002/IS


VPRIV


Iceland


17.9.2010




EU/1/10/647/001/NO-002/NO


Myclausen


Norway


17.11.2010




EU/1/10/647/001-002


Myclausen


Liechtenstein


31.10.2010




EU/1/10/648/001/NO-028/NO


Twynsta


Norway


29.11.2010




EU/1/10/648/001-028


Twynsta


Liechtenstein


31.10.2010




EU/1/10/650/001/NO-015/NO


Clopidogrel Teva Generics B.V.


Norway


26.11.2010




EU/1/10/650/001-015


Clopidogrel Teva Generics B.V.


Liechtenstein


31.12.2010




EU/1/10/651/001/NO-015/NO


Clopidogrel HCS


Norway


26.11.2010




EU/1/10/651/001-015


Clopidogrel HCS


Liechtenstein


31.12.2010




EU/1/10/654/001-004


Leflunomide Ratiopharm


Liechtenstein


31.12.2010




EU/1/10/655/001/NO-006/NO


Brilique


Norway


16.12.2010




EU/1/10/655/001-006


Brilique


Liechtenstein


31.12.2010




EU/1/10/655/001-006/IS


Brilique


Iceland


10.12.2010




EU/1/10/656/001-006


Possia


Liechtenstein


31.12.2010




EU/1/10/657/001-002


Präpandemischer Influenzaimpfstoff (H5N1)


Liechtenstein


31.12.2010




EU/1/10/658/001-002


Aflunov


Liechtenstein


31.12.2010




EU/2/10/106/001/NO-014/NO


Bovilis BTV8


Norway


5.10.2010




EU/2/10/106/001-014


Bovilis BTV8


Liechtenstein


31.10.2010




EU/2/10/106/001-014/IS


Bovilis BTV8


Iceland


20.10.2010




EU/2/10/108/001/NO-005/NO


BTVPUR Alsap 2-4


Norway


22.11.2010




EU/2/10/108/001-005


BTVPUR Alsap 2-4


Liechtenstein


31.12.2010




EU/2/10/109/001-009


Rhiniseng


Liechtenstein


31.10.2010




EU/2/10/109/001-009/IS


Rhiniseng


Iceland


10.12.2010




EU/2/10/110/001-002


Coxevac


Liechtenstein


31.10.2010




EU/2/10/111/001-004


Meloxoral


Liechtenstein


31.12.2010







ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July-31 December 2010:








EU-Number


Product


Country


Date of authorisation




EU/1/00/135/001/NO-002/NO


DaTSCAN


Norway


6.9.2010




EU/1/00/135/001-002


DaTSCAN


Liechtenstein


31.8.2010




EU/1/00/141/001/NO


Myocet


Norway


3.8.2010




EU/1/00/141/001


Myocet


Liechtenstein


31.8.2010




EU/1/00/141/001/IS


Myocet


Iceland


30.8.2010




EU/1/00/142/004/NO-005/NO, 009/NO-022/NO


NovoMix


Norway


4.8.2010




EU/1/00/142/004-005, 009-022


NovoMix


Liechtenstein


31.8.2010




EU/1/00/142/004-005, 009-022/IS


NovoMix


Iceland


31.8.2010




EU/1/00/143/001/NO-011/NO


Kogenate Bayer


Norway


26.8.2010




EU/1/00/143/001-011


Kogenate Bayer


Liechtenstein


31.8.2010




EU/1/00/143/004-011/IS


Kogenate Bayer


Iceland


8.9.2010




EU/1/00/144/001/NO-004/NO


Helixate NexGen


Norway


25.8.2010




EU/1/00/144/001-004


Helixate NexGen


Liechtenstein


31.8.2010




EU/1/00/144/001-004/IS


Helixate NexGen


Iceland


29.9.2010




EU/1/00/145/001


Herceptin


Liechtenstein


31.8.2010




EU/1/00/145/001/IS


Herceptin


Iceland


6.9.2010




EU/1/00/145/001/NO


Herceptin


Norway


24.8.2010




EU/1/00/146/001/NO-032/NO


Keppra


Norway


1.11.2010




EU/1/00/146/001-032


Keppra


Liechtenstein


31.10.2010




EU/1/00/146/001-032/IS


Keppra


Iceland


2.9.2010




EU/1/00/149/001


Panretin


Liechtenstein


31.10.2010




EU/1/00/149/001/NO


Panretin


Norway


22.10.2010




EU/1/00/150/001/NO-024/NO


Actos


Norway


19.10.2010




EU/1/00/150/001-030


Actos


Liechtenstein


31.10.2010




EU/1/00/150/001-030/IS


Actos


Iceland


22.9.2010




EU/1/00/151/001/NO-024/NO


Glustin


Norway


19.10.2010




EU/1/00/151/001-024


Glustin


Liechtenstein


31.10.2010




EU/1/00/151/001-024/IS


Glustin


Iceland


23.9.2010




EU/1/00/152/001/NO-020/NO


Infanrix Hexa


Norway


6.12.2010




EU/1/00/152/001-020


Infanrix Hexa


Liechtenstein


31.10.2010




EU/1/00/152/001-020/IS


Infanrix Hexa


Iceland


22.9.2010




EU/1/00/153/001/NO-010/NO


Infanrix Penta


Norway


3.12.2010




EU/1/00/153/001-010


Infanrix Penta


Liechtenstein


31.10.2010




EU/1/00/153/001-010/IS


Infanrix Penta


Iceland


22.9.2010




EU/1/00/156/002/NO-004/NO


Trizivir


Norway


13.12.2010




EU/1/00/156/002-004


Trizivir


Liechtenstein


31.12.2010




EU/1/00/166/001-003


NeuroBloc


Liechtenstein


31.12.2010




EU/1/05/310/001/NO-009/NO


Fosavance


Norway


13.9.2010




EU/1/05/310/001-009


Fosavance


Liechtenstein


31.8.2010




EU/1/05/310/001-009/IS


Fosavance


Iceland


13.9.2010




EU/1/05/311/001/NO-003/NO


Tarceva


Norway


24.8.2010




EU/1/05/311/001-003


Tarceva


Liechtenstein


31.8.2010




EU/1/05/311/001-003/IS


Tarceva


Iceland


19.8.2010




EU/1/05/312/001


Xyrem


Liechtenstein


31.10.2010




EU/1/05/312/001/NO


Xyrem


Norway


16.11.2010




EU/1/05/313/001/NO-009/NO


Vasovist


Norway


22.12.2010




EU/1/05/313/001-009


Vasovist


Liechtenstein


31.10.2010




EU/1/05/314/001


Kepivance


Liechtenstein


31.12.2010




EU/1/05/315/001/NO-002/NO


Aptivus


Norway


13.12.2010




EU/1/05/315/001-002


Aptivus


Liechtenstein


31.10.2010




EU/1/05/316/001/NO-014/NO


Procoralan


Norway


28.9.2010




EU/1/05/316/001-014


Procoralan


Liechtenstein


31.10.2010




EU/1/05/316/001-014/IS


Procoralan


Iceland


21.9.2010




EU/1/05/317/001/NO-014/NO


Corlentor


Norway


28.9.2010




EU/1/05/317/001-014


Corlentor


Liechtenstein


31.10.2010




EU/1/05/317/001-014/IS


Corlentor


Iceland


21.9.2010




EU/1/05/318/001/NO-002/NO


Revatio


Norway


6.10.2010




EU/1/05/318/001-002


Revatio


Liechtenstein


31.10.2010




EU/1/05/318/001-002/IS


Revatio


Iceland


20.12.2010




EU/1/05/319/001/NO-010/NO


Xolair


Norway


19.10.2010




EU/1/05/319/001-010


Xolair


Liechtenstein


31.10.2010




EU/1/05/319/001-010/IS


Xolair


Iceland


15.12.2010




EU/1/05/320/001/NO


Noxafil


Norway


13.12.2010




EU/1/05/328/001-004


Cubicin


Liechtenstein


31.12.2010




EU/1/05/331/001-055


Neupro


Liechtenstein


31.12.2010




EU/1/06/338/001/NO-003/NO


Duo Trav


Norway


18.11.2010




EU/1/06/338/001-003


Duo Trav


Liechtenstein


31.10.2010




EU/1/07/423/001-003


Vectibix


Liechtenstein


31.12.2010




EU/1/07/440/001-002


Tyverb


Liechtenstein


31.10.2010




EU/1/08/468/001


Intelence


Liechtenstein


31.8.2010




EU/1/08/468/001/IS


Intelence


Iceland


30.8.2010




EU/1/08/468/001/NO


Intelence


Norway


19.8.2010




EU/1/09/543/001


Cayston


Liechtenstein


31.10.2010




EU/1/09/543/001/NO


Cayston


Norway


28.9.2010




EU/1/09/543/001-002/IS


Cayston


Iceland


16.9.2010




EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS


Gonal-f


Iceland


26.8.2010




EU/1/95/001/005, 021, 025-027, 031-033, 035


Gonal-f


Liechtenstein


31.8.2010




EU/1/95/001/005/NO, EU/1/95/001/025/NO-027/NO, EU/1/95/001/031/NO-035/NO


Gonal-f


Norway


9.9.2010




EU/2/00/018/001


Incurin


Liechtenstein


31.8.2010




EU/2/05/053/001-003/IS


Naxcel


Iceland


15.12.2010




EU/2/05/054/001/NO-031/NO


Profender


Norway


4.10.2010




EU/2/05/054/001-031


Profender


Liechtenstein


31.8.2010




EU/2/05/054/001-031/IS


Profender


Iceland


1.9.2010




EU/2/05/055/001/NO-002/NO


Equilis Te


Norway


3.9.2010




EU/2/05/055/001-002/IS


Equilis Te


Iceland


6.9.2010




EU/2/05/056/001/NO-004/NO


Equilis Prequenza


Norway


6.9.2010




EU/2/05/056/001-004/IS


Equilis Prequenza


Iceland


6.9.2010




EU/2/05/057/001/NO-004/NO


Equilis Prequenza Te


Norway


6.9.2010




EU/2/05/057/001-004


Equilis Prequenza Te


Liechtenstein


31.8.2010




EU/2/05/057/001-004/IS


Equilis Prequenza Te


Iceland


6.9.2010




EU/2/055/001-002


Equilis Te


Liechtenstein


31.8.2010







ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July-31 December 2010:








EU-Number


Product


Country


Date of authorisation




EU/1/00/143/012/NO-013/NO


Kogenate Bayer


Norway


26.8.2010




EU/1/00/143/012-013


Kogenate Bayer


Liechtenstein


31.8.2010




EU/1/00/143/012-013/IS


Kogenate Bayer


Iceland


8.9.2010




EU/1/00/144/005


Helixate NexGen


Liechtenstein


31.8.2010




EU/1/00/144/005/IS


Helixate NexGen


Iceland


29.9.2010




EU/1/00/152/019-020/IS


Infanrix Hexa


Iceland


7.7.2010




EU/1/00/152/019/NO-020/NO


Infanrix Hexa


Norway


6.12.2010




EU/1/01/171/013/NO-014/NO


Rapamune


Norway


18.8.2010




EU/1/01/171/013-014/IS


Rapamune


Iceland


6.7.2010




EU/1/01/171013-014


Rapamune


Liechtenstein


31.8.2010




EU/1/01/172/008


Kaletra


Liechtenstein


31.10.2010




EU/1/02/218/030


Axura


Liechtenstein


31.12.2010




EU/1/02/237/009


Cialis


Liechtenstein


31.10.2010




EU/1/03/248/013/NO-015/NO


Levitra


Norway


24.9.2010




EU/1/03/248/013-015/IS


Levitra


Iceland


24.9.2010




EU/1/03/269/002


Faslodex


Liechtenstein


31.12.2010




EU/1/04/179/044/NO


Lyrica


Norway


2.9.2010




EU/1/04/279/044/IS


Lyrica


Iceland


19.8.2010




EU/1/04/307/014/NO-021/NO


Zonegran


Norway


26.8.2010




EU/1/04/307/014-021


Zonegran


Liechtenstein


31.8.2010




EU/1/04/307/014-021/IS


Zonegran


Iceland


27.7.2010




EU/1/05/328/003-004


Cubicin


Liechtenstein


31.10.2010




EU/1/06/363/012/NO-015/NO


Sprycel


Norway


26.10.2010




EU/1/06/363/012-015


Sprycel


Liechtenstein


31.10.2010




EU/1/06/363/012-015/IS


Sprycel


Iceland


22.11.2010




EU/1/07/401/012-015


Alli


Liechtenstein


31.12.2010




EU/1/07/420/002


Cyanokit


Liechtenstein


31.10.2010




EU/1/07/437/003/NO-004/NO


Ivemend


Norway


28.9.2010




EU/1/07/437/003-004


Ivemend


Liechtenstein


31.10.2010




EU/1/07/437/003-004/IS


Ivemend


Iceland


23.9.2010




EU/1/070/401/011


Alli


Liechtenstein


31.8.2010




EU/1/08/447/005-012


Adenuric


Liechtenstein


31.10.2010




EU/1/08/454/006-007


Extavia


Liechtenstein


31.8.2010




EU/1/08/463/004/NO-011/NO


Relistor


Norway


26.10.2010




EU/1/08/463/004-0011/IS


Relistor


Iceland


16.9.2010




EU/1/08/472/009-010


Xarelto


Liechtenstein


31.10.2010




EU/1/08/495/009-016


Zarzio


Liechtenstein


31.12.2010




EU/1/08/496/009-016


Filgrastim Hexal


Liechtenstein


31.12.2010




EU/1/08/504/003


Firmagon


Liechtenstein


31.12.2010




EU/1/09/535/015-016


Grepid


Liechtenstein


31.8.2010




EU/1/09/543/002


Cayston


Liechtenstein


31.10.2010




EU/1/09/580/019-021


Enyglid


Liechtenstein


31.12.2010




EU/1/10/619/015


DuoPlavin


Liechtenstein


31.8.2010




EU/1/10/623/015


DuoCover


Liechtenstein


31.8.2010




EU/1/96/006/007


NovoSeven


Liechtenstein


31.12.2010




EU/1/96/016/007


Norvir


Liechtenstein


31.12.2010




EU/1/97/050/028/NO-033/NO


Sifrol


Norway


10.8.2010




EU/1/97/050/028-033/IS


Sifrol


Iceland


18.8.2010




EU/1/97/051/028/NO-033/NO


Mirapexin


Norway


30.8.2010




EU/1/97/051/028-033/IS


Mirapexin


Iceland


18.8.2010




EU/1/99/108/004/NO-006/NO


Ferriprox


Norway


10.9.2010




EU/1/99/108/004-006


Ferriprox


Liechtenstein


31.8.2010




EU/1/99/108/004-006/IS


Ferriprox


Iceland


2.9.2010




EU/2/97/004/039-040


Metacam


Liechtenstein


31.8.2010




EU/2/00/026/005-006


Porcilis AR


Liechtenstein


31.10.2010




EU/2/06/070/005-008/IS


Meloxidyl


Iceland


15.9.2010




EU/2/06/070/008


Meloxidyl


Liechtenstein


31.10.2010




EU/2/06/070/008/NO


Meloxidyl


Norway


5.10.2010




EU/2/07/072/003/NO-004/NO


Suprelorin


Norway


5.10.2010




EU/2/07/072/003-004


Suprelorin


Liechtenstein


31.8.2010




EU/2/07/072/003-004/IS


Suprelorin


Iceland


24.8.2010




EU/2/08/083/004-005


Equioxx


Liechtenstein


31.10.2010




EU/2/09/095/004-006


Improvac


Liechtenstein


31.10.2010




EU/2/97/004/039/NO-040/NO


Metacam


Norway


8.9.2010




EU/2/97/004/039-042/IS


Metacam


Iceland


6.7.2010




EU/2/97/004/041/NO-042/NO


Metacam


Norway


8.9.2010







ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2010:








EU-Number


Product


Country


Date of withdrawal




EU/1/00/148/001/NO-004/NO


Agenerase


Norway


14.9.2010




EU/1/00/154/001/NO-002/NO


NeoSpect


Norway


8.12.2010




EU/1/00/154/001-002


NeoSpect


Liechtenstein


31.12.2010




EU/1/02/239/001-030/IS


Bextra


Iceland


31.8.2010




EU/1/02/244/001-020/IS


Valdyn


Iceland


31.8.2010




EU/1/07/406/001-020


Enviage


Liechtenstein


31.10.2010




EU/1/10/613/001-002


ImmunoGam


Liechtenstein


31.10.2010




EU/1/10/613/001/NO-002/NO


ImmunoGam


Norway


1.11.2010




EU/1/10/613/001-002/IS


ImmunoGam


Iceland


30.9.2010




EU/1/10/624/001


Arepanrix


Liechtenstein


31.12.2010




EU/2/00/024/001


Pruban


Liechtenstein


31.8.2010




EU/2/07/073/001-004


Nobilis Influenza H7N1


Liechtenstein


31.8.2010




EU/2/00/024/001/IS


Pruban 0,1 %


Iceland


16.11.2010




EU/2/06/067/001-002


Medicinal Oxygen Air Liquide Santé


Liechtenstein


31.8.2010




EU/2/06/067/001-002/IS


Medicinal oxygen


Iceland


1.9.2010




EU/2/07/073/001-004/IS


Nobilis Influenza H7N1


Iceland


1.9.2010




EU/2/07/076/001-004


Nobilis Influenza H5N6


Liechtenstein


31.8.2010




EU/2/07/076/001-004/IS


Nobilis Influenza H5N6


Iceland


1.9.2010







ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2010:








EU-Number


Product


Country


Date of suspension




EU/1/00/137/002/NO-018/NO


Avandia (1)



Norway


3.12.2010




EU/1/00/137/002-018


Avandia


Liechtenstein


31.12.2010




EU/1/03/258/001/NO-022/NO


Avandamet (1)



Norway


3.12.2010




EU/1/03/258/001-022


Avandamet


Liechtenstein


31.12.2010




EU/1/06/349/001/NO-010/NO


Avaglim (1)



Norway


3.12.2010




EU/1/06/349/001-010


Avaglim


Liechtenstein


31.12.2010




EU/2/06/058/001-003


Flexicam


Liechtenstein


31.10.2010






(1)  Suspended in Norway without notification.