EN Official Journal of the European Union C 237/2

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2009

2010/C 237/02

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 2009, at their meeting on 30 April 2010:

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II — List of renewed marketing authorisations Annex III — List of extended marketing authorisations Annex IV — List of withdrawn marketing authorisations Annex V — List of suspended marketing authorisations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 2009: EU-Number Product Country Date of authorisation EU/1/06/361/001/NO-002/NO Luminity Norway 20.8.2009 EU/1/07/436/001-002 Isentress Liechtenstein 31.8.2009 EU/1/09/575/001-060 Copalia HCT Liechtenstein 31.12.2009 EU/1/09/511/001-004 Conbriza Liechtenstein 31.10.2009 EU/1/09/515/001-004/IS Controloc Control Iceland 7.9.2009 EU/1/09/516/001/NO Somac Norway 13.7.2009 EU/1/09/516/001-004/IS Somac Control Iceland 7.9.2009 EU/1/09/516/002/NO Pantoloc Norway 13.7.2009 EU/1/09/516/003/NO Pantecta Norway 13.7.2009 EU/1/09/516/004/NO Controloc Norway 13.7.2009 EU/1/09/517/001/NO-002/NO Pantozol Norway 9.7.2009 EU/1/09/517/001-004/IS Pantozol Control Iceland 7.9.2009 EU/1/09/518/001-004/IS Pantecta Control Iceland 7.9.2009 EU/1/09/519/001-004/IS Pantoloc Control Iceland 7.9.2009 EU/1/09/521/001/NO-007/NO Renvela Norway 7.10.2009 EU/1/09/521/001-007/IS Renvela Iceland 4.9.2009 EU/1/09/523/001/NO-002/NO Modigraf Norway 21.10.2009 EU/1/09/523/001-002/IS Modigraf Iceland 23.7.2009 EU/1/09/524/001/NO-002/NO Qutenza Norway 5.8.2009 EU/1/09/524/001-002/IS Qutenza Iceland 21.7.2009 EU/1/09/525/001/NO-046/NO Nimvastid Norway 2.11.2009 EU/1/09/526/001/IS Iressa Iceland 11.9.2009 EU/1/09/526/001/NO Iressa Norway 2.9.2009 EU/1/09/527/001/NO-016/NO Ribaverin Teva Pharma Norway 12.8.2009 EU/1/09/527/001-016 Ribavirin Teva Pharma BV Liechtenstein 31.8.2009 EU/1/09/527/001-016/IS Ribavirin Teva Pharma BV Iceland 17.9.2009 EU/1/09/528/001 Nymusa Liechtenstein 31.8.2009 EU/1/09/528/001/IS Nymusa Iceland 17.9.2009 EU/1/09/528/001/NO Nymusa Norway 12.8.2009 EU/1/09/529/001/NO-005/NO Victoza Norway 4.8.2009 EU/1/09/529/001-005 Victoza Liechtenstein 31.8.2009 EU/1/09/529/001-005/IS Victoza Iceland 15.9.2009 EU/1/09/530/001/NO-015/NO Repaglinide Teva Norway 12.8.2009 EU/1/09/530/001-015 Repaglinide Teva Liechtenstein 31.8.2009 EU/1/09/530/001-015/IS Repaglinide Teva Iceland 11.9.2009 EU/1/09/531/001/NO-009/NO Instanyl Norway 17.8.2009 EU/1/09/531/001-009 Instanyl Liechtenstein 31.8.2009 EU/1/09/531/001-009/IS Instanyl Iceland 24.9.2009 EU/1/09/532/001/NO-007/NO Clopidogrel Acino Norway 25.8.2009 EU/1/09/532/001-007 Clopidogrel Acino Liechtenstein 31.8.2009 EU/1/09/532/001-007/IS Clopidogrel Acino Iceland 24.9.2009 EU/1/09/533/001/NO-003/NO Vedrop Norway 20.8.2009 EU/1/09/533/001-003 Vedrop Liechtenstein 31.8.2009 EU/1/09/533/001-003/IS Vedrop Iceland 5.11.2009 EU/1/09/534/001/NO-007/NO Clopidogrel Hexal Norway 25.8.2009 EU/1/09/534/001-007 Clopidogrel Hexal Liechtenstein 31.8.2009 EU/1/09/534/001-007/IS Clopidogrel Hexal Iceland 28.9.2009 EU/1/09/535/001/NO-014/NO Grepid Norway 20.8.2009 EU/1/09/535/001-014 Grepid Liechtenstein 31.8.2009 EU/1/09/535/001-014/IS Grepid Iceland 9.9.2009 EU/1/09/536/001/NO-002/NO Topotecan Actavis Norway 26.8.2009 EU/1/09/536/001-002 Topotecan Actavis Liechtenstein 31.8.2009 EU/1/09/536/001-002/IS Topotecan Actavis Iceland 29.9.2009 EU/1/09/537/001 Mozobil Liechtenstein 31.8.2009 EU/1/09/537/001/IS Mozobil Iceland 14.10.2009 EU/1/09/537/001/NO Mozobil Norway 10.8.2009 EU/1/09/538/001/NO-006/NO Afinitor Norway 10.8.2009 EU/1/09/538/001-006 Afinitor Liechtenstein 31.8.2009 EU/1/09/538/001-006/IS Afinitor Iceland 15.10.2009 EU/1/09/539/001/NO-004/NO Samsca Norway 21.9.2009 EU/1/09/539/001-004 Samsca Liechtenstein 31.8.2009 EU/1/09/539/001-004/IS Samsca Iceland 22.9.2009 EU/1/09/540/001/NO-009/NO Clopidogrel Teva Norway 20.8.2009 EU/1/09/540/001-009 Clopidogrel Teva Liechtenstein 31.8.2009 EU/1/09/540/001-009/IS Clopidogrel Teva Iceland 29.9.2009 EU/1/09/541/001/NO-007/NO Clopidogrel ratiopharm GmbH Norway 20.8.2009 EU/1/09/541/001-007 Clopidogrel ratiopharm GmbH Liechtenstein 31.8.2009 EU/1/09/541/001-007/IS Clopidogrel ratiopharm GmbH Iceland 24.9.2009 EU/1/09/542/001/NO-007/NO Clopidogrel 1A Pharma Norway 20.8.2009 EU/1/09/542/001-007 Clopidogrel 1A Pharma Liechtenstein 31.8.2009 EU/1/09/542/001-007/IS Clopidogrel 1A Pharma Iceland 28.9.2009 EU/1/09/543/001 Cayston Liechtenstein 31.10.2009 EU/1/09/543/001/IS Cayston Iceland 9.11.2009 EU/1/09/543/001/NO Cayston Norway 30.9.2009 EU/1/09/544/001/NO-002/NO Cimzia Norway 21.10.2009 EU/1/09/544/001-002 Cimzia Liechtenstein 31.10.2009 EU/1/09/544/001-002/IS Cimzia Iceland 24.11.2009 EU/1/09/545/001/NO-010/NO Onglyza Norway 8.10.2009 EU/1/09/545/001-010 Onglyza Liechtenstein 31.10.2009 EU/1/09/545/001-010/IS Onglyza Iceland 12.11.2009 EU/1/09/546/001/NO-004/NO Simponi Norway 16.10.2009 EU/1/09/546/001-004 Simponi Liechtenstein 31.10.2009 EU/1/09/546/001-004/IS Simponi Iceland 2.11.2009 EU/1/09/547/001/NO-007/NO Clopidogrel Sandoz Norway 15.10.2009 EU/1/09/547/001-007 Clopidogrel Sandoz Liechtenstein 31.10.2009 EU/1/09/547/001-007/IS Clopidogrel Sandoz Iceland 25.9.2009 EU/1/09/548/001/NO-007/NO Clopidogrel Acino Pharma GmbH Norway 16.11.2009 EU/1/09/548/001-007 Clopidogrel Acino Pharma GmbH Liechtenstein 31.10.2009 EU/1/09/548/001-007/IS Clopidogrel Acino Pharma GmbH Iceland 24.9.2009 EU/1/09/549/001/NO-007/NO Clopidogrel Acino Pharma Norway 16.11.2009 EU/1/09/549/001-007 Clopidogrel Acino Pharma Liechtenstein 31.10.2009 EU/1/09/549/001-007/IS Clopidogrel Acino Pharma Iceland 30.11.2009 EU/1/09/550/001/NO-012/NO Javlor Norway 21.10.2009 EU/1/09/550/001-012 Javlor Liechtenstein 31.10.2009 EU/1/09/550/001-012/IS Javlor Iceland 10.11.2009 EU/1/09/551/001/NO-012/NO Vizarsin Norway 30.9.2009 EU/1/09/551/001-012 Vizarsin Liechtenstein 31.10.2009 EU/1/09/551/001-012/IS Vizarsin Iceland 6.11.2009 EU/1/09/552/001/NO-004/NO Topotecan Teva Norway 21.10.2009 EU/1/09/552/001-004 Topotecan Teva Liechtenstein 31.10.2009 EU/1/09/552/001-004/IS Topotecan Teva Iceland 10.11.2009 EU/1/09/553/001/NO-010/NO Zyllt Norway 15.10.2009 EU/1/09/553/001-010 Zyllit Liechtenstein 31.10.2009 EU/1/09/553/001-010/IS Zyllt Iceland 5.11.2009 EU/1/09/554/001/NO-007/NO Clopidogrel ratiopharm Norway 28.10.2009 EU/1/09/554/001-007 Clopidogrel ratiopharm Liechtenstein 31.10.2009 EU/1/09/554/001-007/IS Clopidogrel ratiopharm Iceland 27.11.2009 EU/1/09/555/001/NO-009/NO Clopidogrel TAD Norway 15.10.2009 EU/1/09/555/001-009 Clopidogrel TAD Liechtenstein 31.10.2009 EU/1/09/555/001-009/IS Clopidogrel TAD Iceland 2.12.2009 EU/1/09/556/001/NO-009/NO Clopidogrel Krka Norway 15.10.2009 EU/1/09/556/001-009 Clopidogrel Krka Liechtenstein 31.10.2009 EU/1/09/556/001-009/IS Clopidogrel Krka Iceland 17.11.2009 EU/1/09/557/001/NO-009/NO Clopidogrel Qualimed Norway 15.10.2009 EU/1/09/557/001-009 Clopidogrel Qualimed Liechtenstein 31.10.2009 EU/1/09/557/001-009/IS Clopidogrel Qualimed Iceland 3.11.2009 EU/1/09/558/001/NO-010/NO Zylagren Norway 30.9.2009 EU/1/09/558/001-010 Zylagren Liechtenstein 31.10.2009 EU/1/09/558/001-010/IS Zylagren Iceland 5.11.2009 EU/1/09/559/001/NO-009/NO Clopidogrel Mylan Norway 15.10.2009 EU/1/09/559/001-009 Clopidogrel Mylan Liechtenstein 31.10.2009 EU/1/09/559/001-009/IS Clopidogrel Mylan Iceland 29.9.2009 EU/1/09/560/001/NO-009/NO Clopidogrel Dura Norway 15.10.2009 EU/1/09/560/001-009 Clopidogrel Dura Liechtenstein 31.10.2009 EU/1/09/560/001-009/IS Clopidogrel Dura Iceland 2.11.2009 EU/1/09/561/001/NO-009/NO Clopidogrel HCS Norway 15.10.2009 EU/1/09/561/001-009 Clopidogrel HCS Liechtenstein 31.10.2009 EU/1/09/561/001-009/IS Clopidogrel HCS Iceland 3.11.2009 EU/1/09/562/001/NO-009/NO Zopya Norway 30.9.2009 EU/1/09/562/001-009 Zopya Liechtenstein 31.10.2009 EU/1/09/562/001-009/IS Zopya Iceland 3.11.2009 EU/1/09/563/001 ChondroCelect Liechtenstein 31.10.2009 EU/1/09/563/001/IS ChondroCelect Iceland 30.11.2009 EU/1/09/563/001/NO ChondroCelect Norway 22.10.2009 EU/1/09/564/001/NO-002/NO Ilaris Norway 10.11.2009 EU/1/09/564/001-002 Ilaris Liechtenstein 31.10.2009 EU/1/09/564/001-002/IS Ilaris Iceland 20.11.2009 EU/1/09/565/001/NO-028/NO Biopoin Norway 11.11.2009 EU/1/09/565/001-028 Biopoin Liechtenstein 31.10.2009 EU/1/09/565/001-028/IS Biopoin Iceland 20.11.2009 EU/1/09/566/001/NO-005/NO Lamivudine Teva Norway 16.11.2009 EU/1/09/566/001-005 Lamivudine Teva Liechtenstein 31.10.2009 EU/1/09/566/001-005/IS Lamivudine Teva Iceland 20.11.2009 EU/1/09/568/001/NO-018/NO Klopidogrel Mylan Pharma Norway 16.11.2009 EU/1/09/568/001-018 Clopidogrel Mylan Pharma Liechtenstein 31.10.2009 EU/1/09/568/001-018/IS Clopidogrel Mylan Pharma Iceland 27.11.2009 EU/1/09/569/001/NO-060/NO Exforge HCT Norway 2.11.2009 EU/1/09/569/001-060 Exforge HCT Liechtenstein 31.10.2009 EU/1/09/569/001-060/IS Exforge HCT Iceland 18.11.2009 EU/1/09/570/001/NO-060/NO Imprida HCT Norway 24.11.2009 EU/1/09/570/001-060 Imprida HCT Liechtenstein 31.10.2009 EU/1/09/570/001-060/IS Imprida HCT Iceland 18.11.2009 EU/1/09/571/001 Pandemic Influenza Vaccine H5N1 Baxter Liechtenstein 31.12.2009 EU/1/09/571/001/NO Pandemic Influenza Vaccine H5N1 Baxter Norway 2.12.2009 EU/1/09/572/001/NO-009/NO Alendronate Sodium and Colecalciferol MSD Norway 14.12.2009 EU/1/09/572/001-009 Alendronate Sodium and Colecalciferol MSD Liechtenstein 31.10.2009 EU/1/09/572/001-009/IS Alendronate Sodium and Colecalciferol MSD Iceland 26.11.2009 EU/1/09/573/001/NO-028/NO Eporatio Norway 11.11.2009 EU/1/09/573/001-028 Eporatio Liechtenstein 31.12.2009 EU/1/09/573/001-028/IS Eporatio Iceland 20.11.2009 EU/1/09/574/001/NO-060/NO Dafiro HCT Norway 25.11.2009 EU/1/09/574/001-060 Dafiro HCT Liechtenstein 31.12.2009 EU/1/09/574/001-060/IS Dafiro HCT Iceland 25.11.2009 EU/1/09/575/001/NO-060/NO Copalia Norway 25.11.2009 EU/1/09/575/001-060/IS Copalia HCT Iceland 26.11.2009 EU/1/09/576/001/NO-039/NO Irbesartan Teva Norway 11.11.2009 EU/1/09/576/001-039 Irbesartan Teva Liechtenstein 31.12.2009 EU/1/09/576/001-039/IS Irbesartan Teva Iceland 25.11.2009 EU/1/09/577/001-004 Foclivia Liechtenstein 31.12.2009 EU/1/09/578/001 Pandemic Influenza Vaccine (H5N1) GlaxoSmithKline Biologicals Liechtenstein 31.12.2009 EU/1/09/578/001/NO Pandemivaksine mot influensa Norway 1.12.2009 EU/1/09/579/001/NO-018/NO Repaglinide Krka Norway 10.12.2009 EU/1/09/579/001-018 Repaglinide Krka Liechtenstein 31.12.2009 EU/1/09/579/001-018/IS Repaglinide Krka Iceland 17.11.2009 EU/1/09/580/001/NO-018/NO Enyglid Norway 13.11.2009 EU/1/09/580/001-018 Enyglid Liechtenstein 31.10.2009 EU/1/09/580/001-018/IS Enyglid Iceland 17.11.2009 EU/1/09/581/001/NO-002/NO Resolor Norway 14.12.2009 EU/1/09/581/001-002 Resolor Liechtenstein 31.10.2009 EU/1/09/581/001-002/IS Resolor Iceland 18.11.2009 EU/1/09/582/001 Arcalyst Liechtenstein 31.10.2009 EU/1/09/582/001/IS Arcalyst Iceland 20.11.2009 EU/1/09/582/001/NO Arcalyst Norway 11.11.2009 EU/1/09/583/001-072/IS Irbesartan/Hydrochlorothiazide Teva Iceland 17.12.2009 EU/1/09/584/001/NO-018/NO Sildenafil Teva Norway 15.12.2009 EU/1/09/584/001-018/IS Sildenafil Teva Iceland 23.12.2009 EU/1/09/586/001-010/IS Oslif Breezhaler Iceland 22.12.2009 EU/1/09/590/001-006/IS Prevenar 13 Iceland 16.12.2009 EU/1/09/591/001/NO-004/NO Multaq Norway 15.12.2009 EU/1/09/591/001-004/IS Multaq Iceland 21.12.2009 EU/1/09/593/001-010/IS Onbrez Breezhaler Iceland 22.12.2009 EU/1/09/594/001-010/IS Hirobriz Breezhaler Iceland 22.12.2009 EU/1/97/045/001/NO-004/NO Helicobacter Test INFAI Norway 21.9.2009 EU/2/07/076/001-004/IS Nobilis Influenza H5N6 Iceland 7.9.2009 EU/2/08/083/001/IS Equioxx Iceland 21.7.2009 EU/2/08/086/001-003/IS Duvaxyn WNV Iceland 4.11.2009 EU/2/09/095/001-003/IS Improvac Iceland 3.11.2009 EU/2/09/096/001-002/IS Leucogen Iceland 11.9.2009 EU/2/09/097/001/NO-002/NO Leucofeligen FeLV/RCP Norway 13.7.2009 EU/2/09/097/001-002 Leucofeligen FeLV/RCP Liechtenstein 31.8.2009 EU/2/09/097/001-002/IS Leucofeligen FeLV/RCP Iceland 11.9.2009 EU/2/09/098/001 Melovem Liechtenstein 31.8.2009 EU/2/09/098/001/IS Melovem Iceland 22.9.2009 EU/2/09/098/001/NO Melovem Norway 4.9.2009 EU/2/09/099/001/NO-006/NO Suvaxyn PCV vet Norway 18.8.2009 EU/2/09/099/001-006 Suvaxyn PCV Liechtenstein 31.8.2009 EU/2/09/099/001-006/IS Suvaxyn PCV Iceland 28.9.2009 EU/2/09/100/001/NO-003/NO Palladia Norway 29.10.2009 EU/2/09/100/001-003 Palladia Liechtenstein 31.10.2009 EU/2/09/100/001-003/IS Palladia Iceland 11.11.2009

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 2009: EU-Number Product Country Date of authorisation EU/1/03/264/001/NO Zevalin Norway 21.8.2009 EU/1/03/270/001/NO-003/NO Kentera Norway 9.7.2009 EU/1/04/275/001/NO-002/NO Litak Norway 1.7.2009 EU/1/04/276/001/NO-036/NO Abilify Norway 13.7.2009 EU/1/04/276/001-020,024-036/IS Abilify Iceland 20.7.2009 EU/1/04/277/001/NO-004/NO Tachosil Norway 24.9.2009 EU/1/04/277/001-004/IS Tachosil Iceland 2.9.2009 EU/1/04/279/001/NO-036/NO Lyrica Norway 29.7.2009 EU/1/04/279/001-025,030-043/IS Lyrica Iceland 21.9.2009 EU/1/04/280/001/NO-008/NO Yentreve Norway 18.8.2009 EU/1/04/280/001-008/IS Yentreve Iceland 14.9.2009 EU/1/04/280/001-008 Yentreve Liechtenstein 31.8.2009 EU/1/04/281/001-005/IS Erbitux Iceland 9.9.2009 EU/1/04/282/001/NO-002/NO Telzir Norway 10.8.2009 EU/1/04/282/001-002/IS Telzir Iceland 21.7.2009 EU/1/04/283/008/NO-012/NO Ariclaim Norway 24.8.2009 EU/1/04/283/008-012/IS Ariclaim Iceland 14.9.2009 EU/1/04/284/001 Pedea Liechtenstein 31.8.2009 EU/1/04/284/001/IS Pedea Iceland 28.9.2009 EU/1/04/284/001/NO Pedea Norway 20.10.2009 EU/1/04/285/001/NO-036/NO Apidra Norway 9.9.2009 EU/1/04/285/001-036 Apidra Liechtenstein 31.8.2009 EU/1/04/285/001-036/IS Apidra Iceland 2.10.2009 EU/1/04/286/001/NO-002/NO Wilzin Norway 26.10.2009 EU/1/04/286/001-002 Wilzin Liechtenstein 31.10.2009 EU/1/04/286/001-002/IS Wilzin Iceland 18.11.2009 EU/1/04/287/001/NO-006/NO Osseor Norway 18.12.2009 EU/1/04/287/001-006 Osseor Liechtenstein 31.12.2009 EU/1/04/287/001-006/IS Osseor Iceland 29.11.2009 EU/1/04/288/001/NO-006/NO Protelos Norway 28.12.2009 EU/1/04/288/001-006/IS Protelos Iceland 29.11.2009 EU/1/04/289/001/NO-002/NO Angiox Norway 9.7.2009 EU/1/04/289/001-002 Angiox Liechtenstein 31.8.2009 EU/1/04/289/001-002/IS Angiox Iceland 9.12.2009 EU/1/04/290/001-002 Alimta Liechtenstein 31.10.2009 EU/1/04/290/001-002/IS Alimta Iceland 24.9.2009 EU/1/04/292/001/NO-012/NO Mimpara Norway 6.10.2009 EU/1/04/292/001-012 Mimpara Liechtenstein 31.10.2009 EU/1/04/292/001-012/IS Mimpara Iceland 12.11.2009 EU/1/04/294/001/NO-028/NO Emselex Norway 21.10.2009 EU/1/04/294/001-028/IS Emselex Iceland 5.11.2009 EU/1/04/295/001 Xagrid Liechtenstein 31.12.2009 EU/1/04/295/001/NO Xagrid Norway 16.12.2009 EU/1/04/295/001/IS Xagrid Iceland 10.12.2009 EU/1/04/296/001/NO-009/NO Cymbalta Norway 24.8.2009 EU/1/04/296/001-009/IS Cymbalta Iceland 14.9.2009 EU/1/04/297/001/NO-006/NO Xeristar Norway 27.10.2009 EU/1/04/297/001-008/IS Xeristar Iceland 14.9.2009 EU/1/04/298/001-003/IS Kivexa Iceland 17.12.2009 EU/1/04/304/001-007 Azilect Liechtenstein 31.10.2009 EU/1/04/304/001-007/IS Azilect Iceland 11.11.2009 EU/1/06/367/001-012/IS Diacomit Iceland 21.12.2009 EU/1/07/423/001/NO-003/NO Vectibix Norway 16.7.2009 EU/1/07/436/001-002/IS Isentress Iceland 27.8.2009 EU/1/08/468/001 Intelence Liechtenstein 31.8.2009 EU/1/08/468/001/IS Intelence Iceland 22.10.2009 EU/1/08/468/001/NO Intelence Norway 20.8.2009 EU/1/09/288/001-006 Protelos Liechtenstein 31.12.2009 EU/1/09/555/002/NO Alimta Norway 23.9.2009 EU/1/97/044/001/NO-008/NO Simponi Norway 20.10.2009 EU/1/97/044/001/NO-008/NO Tasmar Norway 20.10.2009 EU/1/97/044/001-008 Tasmar Liechtenstein 31.10.2009 EU/1/97/044/001-008/IS Tasmar Iceland 15.10.2009 EU/1/99/100/001-003/IS Cetrotide Iceland 30.11.2009 EU/1/99/103/001/NO-004/NO Refacto AF Norway 2.7.2009 EU/1/99/107/001/NO-004/NO Rebetol Norway 30.7.2009 EU/1/99/108/001/NO-003/NO Ferriprox Norway 6.10.2009 EU/1/99/108/001-003 Ferriprox Liechtenstein 31.10.2009 EU/1/99/108/001-003/IS Ferriprox Iceland 11.11.2009 EU/1/99/109/001/NO-002/NO Integrilin Norway 10.8.2009 EU/1/99/109/001-002 Integrilin Liechtenstein 31.8.2009 EU/1/99/109/001-002/IS Integrilin Iceland 30.9.2009 EU/1/99/112/001/NO-002/NO Ziagen Norway 26.8.2009 EU/1/99/112/001-002/IS Ziagen Iceland 12.7.2009 EU/1/99/113/001-004 Paxene Liechtenstein 31.8.2009 EU/1/99/113/001-004/IS Paxene Iceland 27.11.2009 EU/1/99/114/001/NO-003/NO Zeffix Norway 16.9.2009 EU/1/99/114/001-003 Zeffix Liechtenstein 31.10.2009 EU/1/99/114/001-003/IS Zeffix Iceland 15.10.2009 EU/1/99/116/001/NO-005/NO Remicade Norway 2.10.2009 EU/1/99/116/001-005 Remicade Liechtenstein 31.8.2009 EU/1/99/116/001-005/IS Remicade Iceland 8.9.2009 EU/1/99/117/001/NO-002/NO Synagis Norway 28.9.2009 EU/1/99/117/001-002 Synagis Liechtenstein 31.8.2009 EU/1/99/117/001-002/IS Synagis Iceland 22.10.2009 EU/1/99/118/001/NO-009/NO Arava Norway 5.10.2009 EU/1/99/118/001-010 Arava Liechtenstein 31.8.2009 EU/1/99/118/001-010/IS Arava Iceland 15.9.2009 EU/1/99/119/001,003,005-015/IS NovoRapid Iceland 26.8.2009 EU/1/99/120/001/NO-004/NO Ammonaps Norway 22.10.2009 EU/1/99/120/001-004 Ammonaps Liechtenstein 31.10.2009 EU/1/99/120/001-004/IS Ammonaps Iceland 17.11.2009 EU/1/99/126/001-021/IS Enbrel Iceland 21.12.2009 EU/2/04/043/001/NO Equilis StrepE Norway 30.7.2009 EU/2/04/044/001/NO-010/NO Aivlosin Norway 18.9.2009 EU/2/04/044/001-010 Aivlosin Liechtenstein 31.10.2009 EU/2/04/044/001-010/IS Aivlosin Iceland 7.10.2009 EU/2/04/045/001-007/IS Previcox Iceland 21.9.2009 EU/2/04/046/001-003 Nobivac Piro Liechtenstein 31.8.2009 EU/2/04/046/001-003/IS Nobivac Piro Iceland 23.9.2009 EU/2/98/009/001-006/IS Suvaxyn Aujeszky 783+O/W Iceland 5.11.2009 EU/2/98/010/017-18,21-24/NO Econor Norway 24.11.2009 EU/2/99/014//001-012 Stronghold Liechtenstein 31.10.2009 EU/2/99/014/001-012/IS Stronghold Iceland 16.12.2009 EU/2/99/015/001-002 Oxyglobin Liechtenstein 31.10.2009 EU/2/99/015/001-002/IS Oxyglobin Iceland 30.11.2009

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 2009: EU-Number Product Country Date of authorisation EU/1/00/146/031-032 Keppra Liechtenstein 31.10.2009 EU/1/00/155/007/IS Luveris Iceland 22.7.2009 EU/1/00/155/007/NO Luveris Norway 12.8.2009 EU/1/01/185/074-099 Aranesp Liechtenstein 31.12.2009 EU/1/01/195/022/NO-025/NO Liprolog Basal Norway 13.8.2009 EU/1/01/195/026/NO-027/NO Liprolog Basal Kwik-Pen Norway 13.8.2009 EU/1/02/220/006 Tracleer Liechtenstein 31.8.2009 EU/1/02/220/006/IS Tracleer Iceland 16.9.2009 EU/1/02/227/004 Neulasta Liechtenstein 31.10.2009 EU/1/05/315/002/IS Aptivus Iceland 26.8.2009 EU/1/05/315/002/NO Aptivus Norway 12.8.2009 EU/1/06/347/007/NO-008/NO Sutent Norway 7.9.2009 EU/1/06/347/007-008/IS Sutent Iceland 9.9.2009 EU/1/06/380/004/NO-005/NO Prezista Norway 12.8.2009 EU/1/06/380/004-005/IS Prezista Iceland 10.9.2009 EU/1/07/384/003-004/IS Docetaxel Winthrop Iceland 28.12.2009 EU/1/07/410/021/NO-026/NO Binocrit Norway 27.10.2009 EU/1/07/410/021-026 Binocrit Liechtenstein 31.10.2009 EU/1/07/410/021-026/IS Binocrit Iceland 15.10.2009 EU/1/07/411/021/NO-026/NO Epoetin alfa Hexal Norway 23.10.2009 EU/1/07/411/021-026 Epoetin alfa Hexal Liechtenstein 31.10.2009 EU/1/07/412/021-026/IS Abseamed Iceland 21.12.2009 EU/1/07/416/002 Ecalta Liechtenstein 31.8.2009 EU/1/07/416/002/IS Ecalta Iceland 25.9.2009 EU/1/07/416/002/NO Ecalta Norway 25.8.2009 EU/1/08/446/005-006 Privigen Liechtenstein 31.8.2009 EU/1/08/453/002 Prepandrix Liechtenstein 31.8.2009 EU/1/08/453/002/IS Prepandrix Iceland 9.11.2009 EU/1/08/489/002 Opgenra Liechtenstein 31.10.2009 EU/1/08/497/003-004 Nplate Liechtenstein 31.10.2009 EU/1/95/002/003-004/IS Taxotere Iceland 23.12.2009 EU/1/95/003/009-010 Betaferon Liechtenstein 31.10.2009 EU/1/97/050/013/NO-027/NO Sifrol Norway 20.10.2009 EU/1/97/050/013-027 Sifrol Liechtenstein 31.10.2009 EU/1/97/050/013-027/IS Sifrol Iceland 12.11.2009 EU/1/97/051/013/NO-027/NO Mirapexin Norway 22.10.2009 EU/1/97/051/013-027 Mirapexin Liechtenstein 31.10.2009 EU/1/97/051/013-027/IS Mirapexin Iceland 12.11.2009 EU/1/99/126/019-021 Enbrel Liechtenstein 31.8.2009 EU/2/04/044/009/NO-010/NO Aivlosin Norway 15.7.2009 EU/2/04/044/009-010/IS Aivlosin Iceland 2.9.2009 EU/2/05/053/003 Naxcel Liechtenstein 31.10.2009 EU/2/05/053/003/IS Naxcel Iceland 13.11.2009 EU/2/05/053/003/NO Naxcel Norway 26.10.2009 EU/2/06/070/004 Meloxidyl Liechtenstein 31.10.2009 EU/2/06/070/004/NO Meloxidyl Norway 20.10.2009 EU/2/07/078/004-006 Zactran Liechtenstein 31.8.2009 EU/2/07/078/005/NO-008/NO Rheumocam Norway 26.10.2009 EU/2/07/078/005-008/IS Rheumocam Iceland 13.11.2009 EU/2/078/005-008 Rheumocam Liechtenstein 31.10.2009 EU/2/98/010/004/NO-006/NO Econor Norway 24.11.2009

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 2009: EU-Number Product Country Date of withdrawal EU/1/01/175/001-021/IS Trazec Iceland 15.12.2009 EU/1/05/321/001/IS Posaconazole SP Iceland 15.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan BMS Norway 1.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan HCT BMS Norway 1.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan BMS Norway 1.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan HCT BMS Norway 1.12.2009 EU/1/06/369/001-028 Irbesartan HCT BMS Liechtenstein 31.12.2009 EU/1/06/369/001-028/IS Irbesartan HCT BMS Iceland 2.12.2009 EU/1/06/375/001-033/IS Irbesartan BMS Iceland 2.12.2009 EU/1/07/385/003/NO Focetria Norway 19.10.2009 EU/1/07/408/001/NO-020/NO Tekturna Norway 17.9.2009 EU/1/07/408/001-020 Tekturna Liechtenstein 31.10.2009 EU/1/07/408/001-020/IS Tekturna Iceland 2.9.2009 EU/1/08/464/001/NO-019/NO Clopidogrel BMS Norway 22.12.2009 EU/1/08/464/001-019/IS Clopidogrel BMS Iceland 2.12.2009 EU/1/08/464/001-019 Clopidogrel BMS Liechtenstein 31.12.2009 EU/1/96/024/006NO,007/NO,009/NO Crixivan Norway 24.9.2009 EU/1/96/024/006NO,007/NO,009/NO Crixivan Norway 24.9.2009 EU/1/99/104/001/IS Procomvax Iceland 15.12.2009 EU/1/99/113/001-004/IS Paxene Iceland 2.12.2009