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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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