DA Den Europæiske Unions Tidende C 237/2

Medicinske specialiteter — Liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i anden halvdel af 2009

2010/C 237/02

Underudvalg I for frie varebevægelser

Til Det Blandede EØS-udvalgs underretning

Under henvisning til afgørelse truffet af Det Blandede EØS-udvalg nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-udvalg til på sit møde den 30. april 2010 at notere sig følgende lister over markedsføringstilladelser for medicinske specialiteter udstedt i perioden 1. juli-31. december 2009:

Bilag I — Liste over nye markedsføringstilladelser Bilag II — Liste over fornyede markedsføringstilladelser Bilag III — Liste over forlængede markedsføringstilladelser Bilag IV — Liste over tilbagetrukne markedsføringstilladelser Bilag V — Liste over suspenderede markedsføringstilladelser

BILAG I Liste over nye markedsføringstilladelser Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne i perioden 1. juli-31. december 2009: EU-nummer Specialitet Land Udstedelsesdato EU/1/06/361/001/NO-002/NO Luminity Norge 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 Island 7.9.2009 EU/1/09/516/001/NO Somac Norge 13.7.2009 EU/1/09/516/001-004/IS Somac Control Island 7.9.2009 EU/1/09/516/002/NO Pantoloc Norge 13.7.2009 EU/1/09/516/003/NO Pantecta Norge 13.7.2009 EU/1/09/516/004/NO Controloc Norge 13.7.2009 EU/1/09/517/001/NO-002/NO Pantozol Norge 9.7.2009 EU/1/09/517/001-004/IS Pantozol Control Island 7.9.2009 EU/1/09/518/001-004/IS Pantecta Control Island 7.9.2009 EU/1/09/519/001-004/IS Pantoloc Control Island 7.9.2009 EU/1/09/521/001/NO-007/NO Renvela Norge 7.10.2009 EU/1/09/521/001-007/IS Renvela Island 4.9.2009 EU/1/09/523/001/NO-002/NO Modigraf Norge 21.10.2009 EU/1/09/523/001-002/IS Modigraf Island 23.7.2009 EU/1/09/524/001/NO-002/NO Qutenza Norge 5.8.2009 EU/1/09/524/001-002/IS Qutenza Island 21.7.2009 EU/1/09/525/001/NO-046/NO Nimvastid Norge 2.11.2009 EU/1/09/526/001/IS Iressa Island 11.9.2009 EU/1/09/526/001/NO Iressa Norge 2.9.2009 EU/1/09/527/001/NO-016/NO Ribaverin Teva Pharma Norge 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 Island 17.9.2009 EU/1/09/528/001 Nymusa Liechtenstein 31.8.2009 EU/1/09/528/001/IS Nymusa Island 17.9.2009 EU/1/09/528/001/NO Nymusa Norge 12.8.2009 EU/1/09/529/001/NO-005/NO Victoza Norge 4.8.2009 EU/1/09/529/001-005 Victoza Liechtenstein 31.8.2009 EU/1/09/529/001-005/IS Victoza Island 15.9.2009 EU/1/09/530/001/NO-015/NO Repaglinide Teva Norge 12.8.2009 EU/1/09/530/001-015 Repaglinide Teva Liechtenstein 31.8.2009 EU/1/09/530/001-015/IS Repaglinide Teva Island 11.9.2009 EU/1/09/531/001/NO-009/NO Instanyl Norge 17.8.2009 EU/1/09/531/001-009 Instanyl Liechtenstein 31.8.2009 EU/1/09/531/001-009/IS Instanyl Island 24.9.2009 EU/1/09/532/001/NO-007/NO Clopidogrel Acino Norge 25.8.2009 EU/1/09/532/001-007 Clopidogrel Acino Liechtenstein 31.8.2009 EU/1/09/532/001-007/IS Clopidogrel Acino Island 24.9.2009 EU/1/09/533/001/NO-003/NO Vedrop Norge 20.8.2009 EU/1/09/533/001-003 Vedrop Liechtenstein 31.8.2009 EU/1/09/533/001-003/IS Vedrop Island 5.11.2009 EU/1/09/534/001/NO-007/NO Clopidogrel Hexal Norge 25.8.2009 EU/1/09/534/001-007 Clopidogrel Hexal Liechtenstein 31.8.2009 EU/1/09/534/001-007/IS Clopidogrel Hexal Island 28.9.2009 EU/1/09/535/001/NO-014/NO Grepid Norge 20.8.2009 EU/1/09/535/001-014 Grepid Liechtenstein 31.8.2009 EU/1/09/535/001-014/IS Grepid Island 9.9.2009 EU/1/09/536/001/NO-002/NO Topotecan Actavis Norge 26.8.2009 EU/1/09/536/001-002 Topotecan Actavis Liechtenstein 31.8.2009 EU/1/09/536/001-002/IS Topotecan Actavis Island 29.9.2009 EU/1/09/537/001 Mozobil Liechtenstein 31.8.2009 EU/1/09/537/001/IS Mozobil Island 14.10.2009 EU/1/09/537/001/NO Mozobil Norge 10.8.2009 EU/1/09/538/001/NO-006/NO Afinitor Norge 10.8.2009 EU/1/09/538/001-006 Afinitor Liechtenstein 31.8.2009 EU/1/09/538/001-006/IS Afinitor Island 15.10.2009 EU/1/09/539/001/NO-004/NO Samsca Norge 21.9.2009 EU/1/09/539/001-004 Samsca Liechtenstein 31.8.2009 EU/1/09/539/001-004/IS Samsca Island 22.9.2009 EU/1/09/540/001/NO-009/NO Clopidogrel Teva Norge 20.8.2009 EU/1/09/540/001-009 Clopidogrel Teva Liechtenstein 31.8.2009 EU/1/09/540/001-009/IS Clopidogrel Teva Island 29.9.2009 EU/1/09/541/001/NO-007/NO Clopifogrel ratiopharm GmbH Norge 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 Island 24.9.2009 EU/1/09/542/001/NO-007/NO Clopidogrel 1A Pharma Norge 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 Island 28.9.2009 EU/1/09/543/001 Cayston Liechtenstein 31.10.2009 EU/1/09/543/001/IS Cayston Island 9.11.2009 EU/1/09/543/001/NO Cayston Norge 30.9.2009 EU/1/09/544/001/NO-002/NO Cimzia Norge 21.10.2009 EU/1/09/544/001-002 Cimzia Liechtenstein 31.10.2009 EU/1/09/544/001-002/IS Cimzia Island 24.11.2009 EU/1/09/545/001/NO-010/NO Onglyza Norge 8.10.2009 EU/1/09/545/001-010 Onglyza Liechtenstein 31.10.2009 EU/1/09/545/001-010/IS Onglyza Island 12.11.2009 EU/1/09/546/001/NO-004/NO Simponi Norge 16.10.2009 EU/1/09/546/001-004 Simponi Liechtenstein 31.10.2009 EU/1/09/546/001-004/IS Simponi Island 2.11.2009 EU/1/09/547/001/NO-007/NO Clopidogrel Sandoz Norge 15.10.2009 EU/1/09/547/001-007 Clopidogrel Sandoz Liechtenstein 31.10.2009 EU/1/09/547/001-007/IS Clopidogrel Sandoz Island 25.9.2009 EU/1/09/548/001/NO-007/NO Clopidogrel Acino Pharma GmbH Norge 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 Island 24.9.2009 EU/1/09/549/001/NO-007/NO Clopidogrel Acino Pharma Norge 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 Island 30.11.2009 EU/1/09/550/001/NO-012/NO Javlor Norge 21.10.2009 EU/1/09/550/001-012 Javlor Liechtenstein 31.10.2009 EU/1/09/550/001-012/IS Javlor Island 10.11.2009 EU/1/09/551/001/NO-012/NO Vizarsin Norge 30.9.2009 EU/1/09/551/001-012 Vizarsin Liechtenstein 31.10.2009 EU/1/09/551/001-012/IS Vizarsin Island 6.11.2009 EU/1/09/552/001/NO-004/NO Topotecan Teva Norge 21.10.2009 EU/1/09/552/001-004 Topotecan Teva Liechtenstein 31.10.2009 EU/1/09/552/001-004/IS Topotecan Teva Island 10.11.2009 EU/1/09/553/001/NO-010/NO Zyllt Norge 15.10.2009 EU/1/09/553/001-010 Zyllit Liechtenstein 31.10.2009 EU/1/09/553/001-010/IS Zyllt Island 5.11.2009 EU/1/09/554/001/NO-007/NO Clopidogrel ratiopharm Norge 28.10.2009 EU/1/09/554/001-007 Clopidogrel ratiopharm Liechtenstein 31.10.2009 EU/1/09/554/001-007/IS Clopidogrel ratiopharm Island 27.11.2009 EU/1/09/555/001/NO-009/NO Clopidogrel TAD Norge 15.10.2009 EU/1/09/555/001-009 Clopidogrel TAD Liechtenstein 31.10.2009 EU/1/09/555/001-009/IS Clopidogrel TAD Island 2.12.2009 EU/1/09/556/001/NO-009/NO Clopidogrel Krka Norge 15.10.2009 EU/1/09/556/001-009 Clopidogrel Krka Liechtenstein 31.10.2009 EU/1/09/556/001-009/IS Clopidogrel Krka Island 17.11.2009 EU/1/09/557/001/NO-009/NO Clopidogrel Qualimed Norge 15.10.2009 EU/1/09/557/001-009 Clopidogrel Qualimed Liechtenstein 31.10.2009 EU/1/09/557/001-009/IS Clopidogrel Qualimed Island 3.11.2009 EU/1/09/558/001/NO-010/NO Zylagren Norge 30.9.2009 EU/1/09/558/001-010 Zylagren Liechtenstein 31.10.2009 EU/1/09/558/001-010/IS Zylagren Island 5.11.2009 EU/1/09/559/001/NO-009/NO Clopidogrel Mylan Norge 15.10.2009 EU/1/09/559/001-009 Clopidogrel Mylan Liechtenstein 31.10.2009 EU/1/09/559/001-009/IS Clopidogrel Mylan Island 29.9.2009 EU/1/09/560/001/NO-009/NO Clopidogrel Dura Norge 15.10.2009 EU/1/09/560/001-009 Clopidogrel Dura Liechtenstein 31.10.2009 EU/1/09/560/001-009/IS Clopidogrel Dura Island 2.11.2009 EU/1/09/561/001/NO-009/NO Clopidogrel HCS Norge 15.10.2009 EU/1/09/561/001-009 Clopidogrel HCS Liechtenstein 31.10.2009 EU/1/09/561/001-009/IS Clopidogrel HCS Island 3.11.2009 EU/1/09/562/001/NO-009/NO Zopya Norge 30.9.2009 EU/1/09/562/001-009 Zopya Liechtenstein 31.10.2009 EU/1/09/562/001-009/IS Zopya Island 3.11.2009 EU/1/09/563/001 ChondroCelect Liechtenstein 31.10.2009 EU/1/09/563/001/IS ChondroCelect Island 30.11.2009 EU/1/09/563/001/NO ChondroCelect Norge 22.10.2009 EU/1/09/564/001/NO-002/NO Ilaris Norge 10.11.2009 EU/1/09/564/001-002 Ilaris Liechtenstein 31.10.2009 EU/1/09/564/001-002/IS Ilaris Island 20.11.2009 EU/1/09/565/001/NO-028/NO Biopoin Norge 11.11.2009 EU/1/09/565/001-028 Biopoin Liechtenstein 31.10.2009 EU/1/09/565/001-028/IS Biopoin Island 20.11.2009 EU/1/09/566/001/NO-005/NO Lamivudine Teva Norge 16.11.2009 EU/1/09/566/001-005 Lamivudine Teva Liechtenstein 31.10.2009 EU/1/09/566/001-005/IS Lamivudine Teva Island 20.11.2009 EU/1/09/568/001/NO-018/NO Klopidogrel Mylan Pharma Norge 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 Island 27.11.2009 EU/1/09/569/001/NO-060/NO Exforge HCT Norge 2.11.2009 EU/1/09/569/001-060 Exforge HCT Liechtenstein 31.10.2009 EU/1/09/569/001-060/IS Exforge HCT Island 18.11.2009 EU/1/09/570/001/NO-060/NO Imprida HCT Norge 24.11.2009 EU/1/09/570/001-060 Imprida HCT Liechtenstein 31.10.2009 EU/1/09/570/001-060/IS Imprida HCT Island 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 Norge 2.12.2009 EU/1/09/572/001/NO-009/NO Alendronate Sodium and Colecalciferol MSD Norge 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 Island 26.11.2009 EU/1/09/573/001/NO-028/NO Eporatio Norge 11.11.2009 EU/1/09/573/001-028 Eporatio Liechtenstein 31.12.2009 EU/1/09/573/001-028/IS Eporatio Island 20.11.2009 EU/1/09/574/001/NO-060/NO Dafiro HCT Norge 25.11.2009 EU/1/09/574/001-060 Dafiro HCT Liechtenstein 31.12.2009 EU/1/09/574/001-060/IS Dafiro HCT Island 25.11.2009 EU/1/09/575/001/NO-060/NO Copalia Norge 25.11.2009 EU/1/09/575/001-060/IS Copalia HCT Island 26.11.2009 EU/1/09/576/001/NO-039/NO Irbesartan Teva Norge 11.11.2009 EU/1/09/576/001-039 Irbesartan Teva Liechtenstein 31.12.2009 EU/1/09/576/001-039/IS Irbesartan Teva Island 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 Norge 1.12.2009 EU/1/09/579/001/NO-018/NO Repaglinide Krka Norge 10.12.2009 EU/1/09/579/001-018 Repaglinide Krka Liechtenstein 31.12.2009 EU/1/09/579/001-018/IS Repaglinide Krka Island 17.11.2009 EU/1/09/580/001/NO-018/NO Enyglid Norge 13.11.2009 EU/1/09/580/001-018 Enyglid Liechtenstein 31.10.2009 EU/1/09/580/001-018/IS Enyglid Island 17.11.2009 EU/1/09/581/001/NO-002/NO Resolor Norge 14.12.2009 EU/1/09/581/001-002 Resolor Liechtenstein 31.10.2009 EU/1/09/581/001-002/IS Resolor Island 18.11.2009 EU/1/09/582/001 Arcalyst Liechtenstein 31.10.2009 EU/1/09/582/001/IS Arcalyst Island 20.11.2009 EU/1/09/582/001/NO Arcalyst Norge 11.11.2009 EU/1/09/583/001-072/IS Irbesartan/Hydrochlorothiazide Teva Island 17.12.2009 EU/1/09/584/001/NO-018/NO Sildenafil Teva Norge 15.12.2009 EU/1/09/584/001-018/IS Sildenafil Teva Island 23.12.2009 EU/1/09/586/001-010/IS Oslif Breezhaler Island 22.12.2009 EU/1/09/590/001-006/IS Prevenar 13 Island 16.12.2009 EU/1/09/591/001/NO-004/NO Multaq Norge 15.12.2009 EU/1/09/591/001-004/IS Multaq Island 21.12.2009 EU/1/09/593/001-010/IS Onbrez Breezhaler Island 22.12.2009 EU/1/09/594/001-010/IS Hirobriz Breezhaler Island 22.12.2009 EU/1/97/045/001/NO-004/NO Helicobacter Test INFAI Norge 21.9.2009 EU/2/07/076/001-004/IS Nobilis Influenza H5N6 Island 7.9.2009 EU/2/08/083/001/IS Equioxx Island 21.7.2009 EU/2/08/086/001-003/IS Duvaxyn WNV Island 4.11.2009 EU/2/09/095/001-003/IS Improvac Island 3.11.2009 EU/2/09/096/001-002/IS Leucogen Island 11.9.2009 EU/2/09/097/001/NO-002/NO Leucofeligen FeLV/RCP Norge 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 Island 11.9.2009 EU/2/09/098/001 Melovem Liechtenstein 31.8.2009 EU/2/09/098/001/IS Melovem Island 22.9.2009 EU/2/09/098/001/NO Melovem Norge 4.9.2009 EU/2/09/099/001/NO-006/NO Suvaxyn PCV vet Norge 18.8.2009 EU/2/09/099/001-006 Suvaxyn PCV Liechtenstein 31.8.2009 EU/2/09/099/001-006/IS Suvaxyn PCV Island 28.9.2009 EU/2/09/100/001/NO-003/NO Palladia Norge 29.10.2009 EU/2/09/100/001-003 Palladia Liechtenstein 31.10.2009 EU/2/09/100/001-003/IS Palladia Island 11.11.2009

BILAG II Liste over fornyede markedsføringstilladelser Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne i perioden 1. juli-31. december 2009: EU-nummer Specialitet Land Udstedelsesdato EU/1/03/264/001/NO Zevalin Norge 21.8.2009 EU/1/03/270/001/NO-003/NO Kentera Norge 9.7.2009 EU/1/04/275/001/NO-002/NO Litak Norge 1.7.2009 EU/1/04/276/001/NO-036/NO Abilify Norge 13.7.2009 EU/1/04/276/001-020,024-036/IS Abilify Island 20.7.2009 EU/1/04/277/001/NO-004/NO Tachosil Norge 24.9.2009 EU/1/04/277/001-004/IS Tachosil Island 2.9.2009 EU/1/04/279/001/NO-036/NO Lyrica Norge 29.7.2009 EU/1/04/279/001-025,030-043/IS Lyrica Island 21.9.2009 EU/1/04/280/001/NO-008/NO Yentreve Norge 18.8.2009 EU/1/04/280/001-008/IS Yentreve Island 14.9.2009 EU/1/04/280/001-008 Yentreve Liechtenstein 31.8.2009 EU/1/04/281/001-005/IS Erbitux Island 9.9.2009 EU/1/04/282/001/NO-002/NO Telzir Norge 10.8.2009 EU/1/04/282/001-002/IS Telzir Island 21.7.2009 EU/1/04/283/008/NO-012/NO Ariclaim Norge 24.8.2009 EU/1/04/283/008-012/IS Ariclaim Island 14.9.2009 EU/1/04/284/001 Pedea Liechtenstein 31.8.2009 EU/1/04/284/001/IS Pedea Island 28.9.2009 EU/1/04/284/001/NO Pedea Norge 20.10.2009 EU/1/04/285/001/NO-036/NO Apidra Norge 9.9.2009 EU/1/04/285/001-036 Apidra Liechtenstein 31.8.2009 EU/1/04/285/001-036/IS Apidra Island 2.10.2009 EU/1/04/286/001/NO-002/NO Wilzin Norge 26.10.2009 EU/1/04/286/001-002 Wilzin Liechtenstein 31.10.2009 EU/1/04/286/001-002/IS Wilzin Island 18.11.2009 EU/1/04/287/001/NO-006/NO Osseor Norge 18.12.2009 EU/1/04/287/001-006 Osseor Liechtenstein 31.12.2009 EU/1/04/287/001-006/IS Osseor Island 29.11.2009 EU/1/04/288/001/NO-006/NO Protelos Norge 28.12.2009 EU/1/04/288/001-006/IS Protelos Island 29.11.2009 EU/1/04/289/001/NO-002/NO Angiox Norge 9.7.2009 EU/1/04/289/001-002 Angiox Liechtenstein 31.8.2009 EU/1/04/289/001-002/IS Angiox Island 9.12.2009 EU/1/04/290/001-002 Alimta Liechtenstein 31.10.2009 EU/1/04/290/001-002/IS Alimta Island 24.9.2009 EU/1/04/292/001/NO-012/NO Mimpara Norge 6.10.2009 EU/1/04/292/001-012 Mimpara Liechtenstein 31.10.2009 EU/1/04/292/001-012/IS Mimpara Island 12.11.2009 EU/1/04/294/001/NO-028/NO Emselex Norge 21.10.2009 EU/1/04/294/001-028/IS Emselex Island 5.11.2009 EU/1/04/295/001 Xagrid Liechtenstein 31.12.2009 EU/1/04/295/001/NO Xagrid Norge 16.12.2009 EU/1/04/295/001/IS Xagrid Island 10.12.2009 EU/1/04/296/001/NO-009/NO Cymbalta Norge 24.8.2009 EU/1/04/296/001-009/IS Cymbalta Island 14.9.2009 EU/1/04/297/001/NO-006/NO Xeristar Norge 27.10.2009 EU/1/04/297/001-008/IS Xeristar Island 14.9.2009 EU/1/04/298/001-003/IS Kivexa Island 17.12.2009 EU/1/04/304/001-007 Azilect Liechtenstein 31.10.2009 EU/1/04/304/001-007/IS Azilect Island 11.11.2009 EU/1/06/367/001-012/IS Diacomit Island 21.12.2009 EU/1/07/423/001/NO-003/NO Vectibix Norge 16.7.2009 EU/1/07/436/001-002/IS Isentress Island 27.8.2009 EU/1/08/468/001 Intelence Liechtenstein 31.8.2009 EU/1/08/468/001/IS Intelence Island 22.10.2009 EU/1/08/468/001/NO Intelence Norge 20.8.2009 EU/1/09/288/001-006 Protelos Liechtenstein 31.12.2009 EU/1/09/555/002/NO Alimta Norge 23.9.2009 EU/1/97/044/001/NO-008/NO Simponi Norge 20.10.2009 EU/1/97/044/001/NO-008/NO Tasmar Norge 20.10.2009 EU/1/97/044/001-008 Tasmar Liechtenstein 31.10.2009 EU/1/97/044/001-008/IS Tasmar Island 15.10.2009 EU/1/99/100/001-003/IS Cetrotide Island 30.11.2009 EU/1/99/103/001/NO-004/NO Refacto AF Norge 2.7.2009 EU/1/99/107/001/NO-004/NO Rebetol Norge 30.7.2009 EU/1/99/108/001/NO-003/NO Ferriprox Norge 6.10.2009 EU/1/99/108/001-003 Ferriprox Liechtenstein 31.10.2009 EU/1/99/108/001-003/IS Ferriprox Island 11.11.2009 EU/1/99/109/001/NO-002/NO Integrilin Norge 10.8.2009 EU/1/99/109/001-002 Integrilin Liechtenstein 31.8.2009 EU/1/99/109/001-002/IS Integrilin Island 30.9.2009 EU/1/99/112/001/NO-002/NO Ziagen Norge 26.8.2009 EU/1/99/112/001-002/IS Ziagen Island 12.7.2009 EU/1/99/113/001-004 Paxene Liechtenstein 31.8.2009 EU/1/99/113/001-004/IS Paxene Island 27.11.2009 EU/1/99/114/001/NO-003/NO Zeffix Norge 16.9.2009 EU/1/99/114/001-003 Zeffix Liechtenstein 31.10.2009 EU/1/99/114/001-003/IS Zeffix Island 15.10.2009 EU/1/99/116/001/NO-005/NO Remicade Norge 2.10.2009 EU/1/99/116/001-005 Remicade Liechtenstein 31.8.2009 EU/1/99/116/001-005/IS Remicade Island 8.9.2009 EU/1/99/117/001/NO-002/NO Synagis Norge 28.9.2009 EU/1/99/117/001-002 Synagis Liechtenstein 31.8.2009 EU/1/99/117/001-002/IS Synagis Island 22.10.2009 EU/1/99/118/001/NO-009/NO Arava Norge 5.10.2009 EU/1/99/118/001-010 Arava Liechtenstein 31.8.2009 EU/1/99/118/001-010/IS Arava Island 15.9.2009 EU/1/99/119/001,003,005-015/IS NovoRapid Island 26.8.2009 EU/1/99/120/001/NO-004/NO Ammonaps Norge 22.10.2009 EU/1/99/120/001-004 Ammonaps Liechtenstein 31.10.2009 EU/1/99/120/001-004/IS Ammonaps Island 17.11.2009 EU/1/99/126/001-021/IS Enbrel Island 21.12.2009 EU/2/04/043/001/NO Equilis StrepE Norge 30.7.2009 EU/2/04/044/001/NO-010/NO Aivlosin Norge 18.9.2009 EU/2/04/044/001-010 Aivlosin Liechtenstein 31.10.2009 EU/2/04/044/001-010/IS Aivlosin Island 7.10.2009 EU/2/04/045/001-007/IS Previcox Island 21.9.2009 EU/2/04/046/001-003 Nobivac Piro Liechtenstein 31.8.2009 EU/2/04/046/001-003/IS Nobivac Piro Island 23.9.2009 EU/2/98/009/001-006/IS Suvaxyn Aujeszky 783+O/W Island 5.11.2009 EU/2/98/010/017-18,21-24/NO Econor Norge 24.11.2009 EU/2/99/014//001-012 Stronghold Liechtenstein 31.10.2009 EU/2/99/014/001-012/IS Stronghold Island 16.12.2009 EU/2/99/015/001-002 Oxyglobin Liechtenstein 31.10.2009 EU/2/99/015/001-002/IS Oxyglobin Island 30.11.2009

BILAG III Liste over forlængede markedsføringstilladelser Følgende markedsføringstilladelser er blevet forlænget i EØS-EFTA-staterne i perioden 1. juli-31. december 2009: EU-nummer Specialitet Land Udstedelsesdato EU/1/00/146/031-032 Keppra Liechtenstein 31.10.2009 EU/1/00/155/007/IS Luveris Island 22.7.2009 EU/1/00/155/007/NO Luveris Norge 12.8.2009 EU/1/01/185/074-099 Aranesp Liechtenstein 31.12.2009 EU/1/01/195/022/NO-025/NO Liprolog Basal Norge 13.8.2009 EU/1/01/195/026/NO-027/NO Liprolog Basal Kwik-Pen Norge 13.8.2009 EU/1/02/220/006 Tracleer Liechtenstein 31.8.2009 EU/1/02/220/006/IS Tracleer Island 16.9.2009 EU/1/02/227/004 Neulasta Liechtenstein 31.10.2009 EU/1/05/315/002/IS Aptivus Island 26.8.2009 EU/1/05/315/002/NO Aptivus Norge 12.8.2009 EU/1/06/347/007/NO-008/NO Sutent Norge 7.9.2009 EU/1/06/347/007-008/IS Sutent Island 9.9.2009 EU/1/06/380/004/NO-005/NO Prezista Norge 12.8.2009 EU/1/06/380/004-005/IS Prezista Island 10.9.2009 EU/1/07/384/003-004/IS Docetaxel Winthrop Island 28.12.2009 EU/1/07/410/021/NO-026/NO Binocrit Norge 27.10.2009 EU/1/07/410/021-026 Binocrit Liechtenstein 31.10.2009 EU/1/07/410/021-026/IS Binocrit Island 15.10.2009 EU/1/07/411/021/NO-026/NO Epoetin alfa Hexal Norge 23.10.2009 EU/1/07/411/021-026 Epoetin alfa Hexal Liechtenstein 31.10.2009 EU/1/07/412/021-026/IS Abseamed Island 21.12.2009 EU/1/07/416/002 Ecalta Liechtenstein 31.8.2009 EU/1/07/416/002/IS Ecalta Island 25.9.2009 EU/1/07/416/002/NO Ecalta Norge 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 Island 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 Island 23.12.2009 EU/1/95/003/009-010 Betaferon Liechtenstein 31.10.2009 EU/1/97/050/013/NO-027/NO Sifrol Norge 20.10.2009 EU/1/97/050/013-027 Sifrol Liechtenstein 31.10.2009 EU/1/97/050/013-027/IS Sifrol Island 12.11.2009 EU/1/97/051/013/NO-027/NO Mirapexin Norge 22.10.2009 EU/1/97/051/013-027 Mirapexin Liechtenstein 31.10.2009 EU/1/97/051/013-027/IS Mirapexin Island 12.11.2009 EU/1/99/126/019-021 Enbrel Liechtenstein 31.8.2009 EU/2/04/044/009/NO-010/NO Aivlosin Norge 15.7.2009 EU/2/04/044/009-010/IS Aivlosin Island 2.9.2009 EU/2/05/053/003 Naxcel Liechtenstein 31.10.2009 EU/2/05/053/003/IS Naxcel Island 13.11.2009 EU/2/05/053/003/NO Naxcel Norge 26.10.2009 EU/2/06/070/004 Meloxidyl Liechtenstein 31.10.2009 EU/2/06/070/004/NO Meloxidyl Norge 20.10.2009 EU/2/07/078/004-006 Zactran Liechtenstein 31.8.2009 EU/2/07/078/005/NO-008/NO Rheumocam Norge 26.10.2009 EU/2/07/078/005-008/IS Rheumocam Island 13.11.2009 EU/2/078/005-008 Rheumocam Liechtenstein 31.10.2009 EU/2/98/010/004/NO-006/NO Econor Norge 24.11.2009

BILAG IV Liste over tilbagetrukne markedsføringstilladelser Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne i perioden 1. juli-31. december 2009: EU-nummer Specialitet Land Udstedelsesdato EU/1/01/175/001-021/IS Trazec Island 15.12.2009 EU/1/05/321/001/IS Posaconazole SP Island 15.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan BMS Norge 1.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan HCT BMS Norge 1.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan BMS Norge 1.12.2009 EU/1/06/369/001/NO-028/NO Irbesartan HCT BMS Norge 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 Island 2.12.2009 EU/1/06/375/001-033/IS Irbesartan BMS Island 2.12.2009 EU/1/07/385/003/NO Focetria Norge 19.10.2009 EU/1/07/408/001/NO-020/NO Tekturna Norge 17.9.2009 EU/1/07/408/001-020 Tekturna Liechtenstein 31.10.2009 EU/1/07/408/001-020/IS Tekturna Island 2.9.2009 EU/1/08/464/001/NO-019/NO Clopidogrel BMS Norge 22.12.2009 EU/1/08/464/001-019/IS Clopidogrel BMS Island 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 Norge 24.9.2009 EU/1/96/024/006NO,007/NO,009/NO Crixivan Norge 24.9.2009 EU/1/99/104/001/IS Procomvax Island 15.12.2009 EU/1/99/113/001-004/IS Paxene Island 2.12.2009