EN Official Journal of the European Union C 230/18

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2008

2009/C 230/08

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 2008, at their meeting on 24 April 2009:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 2008: EU-Number Product Country Date of authorisation EU/1/06/380/001 Prezista Liechtenstein 31.12.2008 EU/1/08/444/001/NO-008/NO Ratiograstim Norway 2.10.2008 EU/1/08/444/001-008 Ratiograstim Liechtenstein 31.10.2008 EU/1/08/444/001-008/IS Ratiograstim Iceland 24.10.2008 EU/1/08/445/001/NO-008/NO Tevagrastim Norway 8.10.2008 EU/1/08/445/001-008 Tevagrastim Liechtenstein 31.10.2008 EU/1/08/445/001-008/IS Tevagrastim Iceland 24.10.2008 EU/1/08/446/001/NO-002/NO Bridion Norway 12.9.2008 EU/1/08/449/001/NO-008/NO Filgrastim Norway 8.10.2008 EU/1/08/449/001-008 Filgrastim Ratiopharm Liechtenstein 31.10.2008 EU/1/08/449/001-008/IS Filgrastim Ratiopharm Iceland 24.10.2008 EU/1/08/450/001/NO-008/NO Biograstim Norway 2.10.2008 EU/1/08/450/001-008 Biograstim Liechtenstein 31.10.2008 EU/1/08/450/001-008/IS Biograstim Iceland 24.10.2008 EU/1/08/452/001/NO Pandemrix Norway 6.8.2008 EU/1/08/453/001/NO Prepandemrix Norway 18.9.2008 EU/1/08/455/001/NO-014/NO Janumet Norway 5.8.2008 EU/1/08/455/001-014 Janumet Liechtenstein 31.8.2008 EU/1/08/455/001-014/IS Janumet Iceland 5.9.2008 EU/1/08/456/001/NO-014/NO Velmetia Norway 5.8.2008 EU/1/08/456/001-014 Velmetia Liechtenstein 31.8.2008 EU/1/08/456/001-014/IS Velmetia Iceland 5.9.2008 EU/1/08/457/001/NO-014/NO Efficib Norway 5.8.2008 EU/1/08/457/001-014 Efficib Liechtenstein 31.8.2008 EU/1/08/457/001-014/IS Efficib Iceland 5.9.2008 EU/1/08/458/001/NO-011/NO Trevaclyn Norway 29.7.2008 EU/1/08/458/001-011 Trevaclyn Liechtenstein 31.8.2008 EU/1/08/458/001-011/IS Trevaclyn Iceland 25.7.2008 EU/1/08/459/001/NO-011/NO Tredaptive Norway 29.7.2008 EU/1/08/459/001-011 Tredaptive Liechtenstein 31.8.2008 EU/1/08/459/001-011/IS Tredaptive Iceland 25.7.2008 EU/1/08/460/001/NO-011/NO Pelzont Norway 29.7.2008 EU/1/08/460/001-011 Pelzont Liechtenstein 31.8.2008 EU/1/08/460/001-011/IS Pelzont Iceland 25.7.2008 EU/1/08/461/001 Firazyr (orphan drug) Liechtenstein 31.8.2008 EU/1/08/461/001/IS Firazyr Iceland 25.7.2008 EU/1/08/461/001/NO Firazyr Norway 25.8.2008 EU/1/08/462/001-006/IS Latixa Iceland 28.7.2008 EU/1/08/463/001/NO-003/NO Relistor Norway 11.7.2008 EU/1/08/463/001-003 Relistor Liechtenstein 31.8.2008 EU/1/08/463/001-003/IS Relistor Iceland 24.7.2008 EU/1/08/464/001/NO-017/NO Clopidogrel BMS Norway 7.8.2008 EU/1/08/464/001-017 Clopidogrel BMS Liechtenstein 31.8.2008 EU/1/08/464/001-017/IS Clopidogrel BMS Iceland 22.9.2008 EU/1/08/465/001/NO-017/NO Clopidogrel Winthrop Norway 7.8.2008 EU/1/08/465/001-017 Clopidogrel Winthrop Liechtenstein 31.8.2008 EU/1/08/465/001-017/IS Clopidogrel Winthrop Iceland 12.9.2008 EU/1/08/466/001-002 Bridion Liechtenstein 31.8.2008 EU/1/08/466/001-002/IS Bridion Iceland 4.9.2008 EU/1/08/467/001 Doribax Liechtenstein 31.8.2008 EU/1/08/467/001/IS Doribax Iceland 8.9.2008 EU/1/08/467/001/NO Doribax Norway 1.9.2008 EU/1/08/468/001 Intelence Liechtenstein 31.10.2008 EU/1/08/468/001/IS Intelence Iceland 26.9.2008 EU/1/08/468/001/NO Intelence Norway 18.9.2008 EU/1/08/468/001/NO-025/NO Oprymea Norway 9.10.2008 EU/1/08/469/001-025 Oprymea Liechtenstein 31.10.2008 EU/1/08/469/001-025/IS Oprymea Iceland 27.10.2008 EU/1/08/470/001/NO-016/NO Vimpat Norway 22.9.2008 EU/1/08/470/001-015/IS Vimpat Iceland 10.9.2008 EU/1/08/470/001-016 Vimpat Liechtenstein 31.10.2008 EU/1/08/471/001/NO-012/NO Duloxetine Boehringer Ingelheim Norway 29.10.2008 EU/1/08/471/001-012 Duloxetine Boehringer Ingelheim Liechtenstein 31.10.2008 EU/1/08/471/001-012/IS Duloxetine Boehringer Ingelheim Iceland 7.11.2008 EU/1/08/472/001/NO-008/NO Xarelto Norway 9.10.2008 EU/1/08/472/001-008 Xarelto Liechtenstein 31.10.2008 EU/1/08/472/001-008/IS Xarelto Iceland 15.10.2008 EU/1/08/473/001/NO-003/NO Evicel Norway 28.10.2008 EU/1/08/473/001-003 Evicel Liechtenstein 31.10.2008 EU/1/08/473/001-003/IS Evicel Iceland 17.11.2008 EU/1/08/474/001-003 Fluticasone furoate GSK Liechtenstein 31.10.2008 EU/1/08/475/001/NO-034/NO Olanzapine Mylan Norway 29.10.2008 EU/1/08/475/001-034 Olanzapine Mylan Liechtenstein 31.10.2008 EU/1/08/475/001-034/IS Olanzapine Mylan Iceland 21.11.2008 EU/1/08/476/001/NO-004/NO Tadalafil Norway 23.10.2008 EU/1/08/476/001-004 Tadalafil Lilly Liechtenstein 31.10.2008 EU/1/08/477/001 Ceplene (orphan) Liechtenstein 31.10.2008 EU/1/08/477/001/IS Ceplene Iceland 19.11.2008 EU/1/08/478/001 Prepandemic influenza vaccine (H5N1) Liechtenstein 31.10.2008 EU/1/08/478/001/IS Prepandemic influenza vaccine (H5N1) Iceland 24.10.2008 EU/1/08/478/001/NO Prepandemic influenza vaccine Norway 4.12.2008 EU/1/08/479/001/NO-003/NO Zypadhera Norway 16.12.2008 EU/1/08/479/001-003 Zypadhera Liechtenstein 31.12.2008 EU/1/08/479/001-003/IS Zypadhera Iceland 16.12.2008 EU/1/08/480/001-018 Irbesartan Krka Liechtenstein 31.12.2008 EU/1/08/481/001-003 Kuvan (orphan drug) Liechtenstein 31.12.2008 EU/1/08/482/001-002 Azarga Liechtenstein 31.12.2008 EU/1/08/483/001-018 Zomarist Liechtenstein 31.12.2008 EU/1/08/484/001-018 Vildagliptin Liechtenstein 31.12.2008 EU/1/08/485/001/NO-011/NO Jalra Norway 4.12.2008 EU/1/08/485/001-011 Jalra Liechtenstein 31.12.2008 EU/1/08/485/001-011/IS Jalra Iceland 16.12.2008 EU/1/08/486/001/NO-011/NO Xiliarx Norway 4.12.2008 EU/1/08/486/001-011 Xiliarx Liechtenstein 31.12.2008 EU/1/08/486/001-011/IS Xiliarx Iceland 16.12.2008 EU/1/08477/001/NO Ceplene Norway 28.10.2008 EU/2/08/080/001-004 Reconcile Liechtenstein 31.8.2008 EU/2/08/080/001-004/IS Reconcile Iceland 5.8.2008 EU/2/08/081/001-003/IS Posatex Iceland 10.9.2008 EU/2/08/082/001-003 Zactran Liechtenstein 31.8.2008 EU/2/08/082/001-003/IS Zactran Iceland 8.9.2008 EU/2/08/083/001 Equioxx Liechtenstein 31.8.2008 EU/2/08/084/001/NO-005/NO Trocoxil Norway 15.10.2008 EU/2/08/084/001-005 Trocoxil Liechtenstein 31.10.2008 EU/2/08/084/001-005/IS Trocoxil Iceland 24.10.2008 EU/2/08/085/001 Easotic Liechtenstein 31.12.2008 EU/2/08/086/001/NO-003/NO Duvaxyn WNV Norway 18.12.2008 EU/2/08/086/001-003 Duvaxyn WNV Liechtenstein 31.12.2008 EU/2/08/087/001-002 Masivet Liechtenstein 31.12.2008 EU/2/08/087/001-002/IS Masivet Iceland 12.12.2008 EU/2/08/088/001-004 Acticam Liechtenstein 31.12.2008

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 2008: EU-Number Product Country Date of authorisation EU/1/00/162/003/NO-005/NO; EU/1/00/162/009/NO-011/NO; EU/1/00/162/015/NO-017/NO; EU/1/00/162/019/NO-021/NO Prandin Norway 15.8.2008 EU/1/00/162/003-005, 009-011, 015-017, 019-021 Prandin Liechtenstein 31.8.2008 EU/1/00/162/003-005, 009-011, 015-017, 019-021/IS Prandin Iceland 26.9.2008 EU/1/03/247/001/NO-002/NO Forsteo Norway 1.7.2008 EU/1/03/252/001/NO-003/NO Fuzeon Norway 12.8.2008 EU/1/03/252/001-003 Fuzeon Liechtenstein 31.8.2008 EU/1/03/252/001-003/IS Fuzeon Iceland 5.8.2008 EU/1/03/254/002 Busilvex Liechtenstein 31.8.2008 EU/1/03/254/002/IS Busilvex Iceland 10.7.2008 EU/1/03/254/002/NO Busilvex Norway 12.8.2008 EU/1/03/255/001/NO-006/NO Ventavis Norway 29.9.2008 EU/1/03/255/001-006 Ventavis Liechtenstein 31.10.2008 EU/1/03/255/001-006/IS Ventavis Iceland 19.10.2008 EU/1/03/256/001/NO-010/NO Humira Norway 25.9.2008 EU/1/03/256/001-010 Humira Liechtenstein 31.10.2008 EU/1/03/256/001-010/IS Humira Iceland 24.10.2008 EU/1/03/258/001/NO-022/NO Avandamet Norway 9.9.2008 EU/1/03/258/001-022 Avandamet Liechtenstein 31.8.2008 EU/1/03/258/001-022/IS Avandamet Iceland 20.10.2008 EU/1/03/259/001/NO-006/NO Onsenal Norway 6.11.2008 EU/1/03/259/001-006 Onsenal Liechtenstein 31.10.2008 EU/1/03/259/001-006/IS Onsenal Iceland 12.12.2008 EU/1/03/260/001/NO-023/NO Stalevo Norway 9.10.2008 EU/1/03/260/001-023 Stalevo Liechtenstein 31.10.2008 EU/1/03/260/001-023/IS Stalevo Iceland 22.10.2008 EU/1/03/261/001/NO-003/NO Emtriva Norway 10.11.2008 EU/1/03/261/001-003 Emtriva Liechtenstein 31.10.2008 EU/1/03/261/001-003/IS Emtriva Iceland 27.10.2008 EU/1/03/262/001/NO-008/NO Emend Norway 8.10.2008 EU/1/03/262/001-008 Emend Liechtenstein 31.10.2008 EU/1/03/262/001-008/IS Emend Iceland 27.10.2008 EU/1/03/269/001 Faslodex Liechtenstein 31.12.2008 EU/1/06/367/001-012 Diacomit Liechtenstein 31.12.2008 EU/1/06/367/001-012/IS Diacomit Iceland 18.12.2008 EU/1/07/436/001-002 Isentress Liechtenstein 31.12.2008 EU/1/07/436/001-002/IS Isentress Iceland 18.12.2008 EU/1/98/064/001 Pylobactell Liechtenstein 31.8.2008 EU/1/98/064/001/IS Pylobactell Iceland 19.10.2008 EU/1/98/064/001/NO Pylobactell Norway 8.12.2008 EU/1/98/065/001/NO-002/NO Optison Norway 18.9.2008 EU/1/98/065/001-002/IS Optison Iceland 10.7.2008 EU/1/98/069/001a/NO-007a/NO; EU/1/98/069/001b/NO-007b/NO EU/1/98/069/008/NO-010/NO Plavix Norway 2.7.2008 EU/1/98/070/001a/NO-007a/NO; EU/1/98/070/001b/NO-007b/NO; EU/1/98/070/008/NO-010/NO Iscover Norway 2.7.2008 EU/1/98/071/001/NO-006/NO Xenical Norway 9.9.2008 EU/1/98/071/001-006/IS Xenical Iceland 10.7.2008 EU/1/98/073/001/NO-004/NO Evista Norway 19.9.2008 EU/1/98/073/001-004 Evista Liechtenstein 31.8.2008 EU/1/98/073/001-004/IS Evista Iceland 22.10.2008 EU/1/98/074/001/NO-004/NO Optruma Norway 19.9.2008 EU/1/98/074/001-004 Optruma Liechtenstein 31.8.2008 EU/1/98/074/001-004/IS Optruma Iceland 22.10.2008 EU/1/98/076/004/NO-006/NO, EU/1/98/076/011/NO-013/NO, EU/1/98/076/018/NO-020/NO, EU/1/98/076/022/NO-024/NO NovoNorm Norway 15.8.2008 EU/1/98/076/004-006, 011-013, 018-020, 022-024 NovoNorm Liechtenstein 31.8.2008 EU/1/98/076/004-006, 011-013, 018-020, 022-024/IS NovoNorm Iceland 25.9.2008 EU/1/98/077/002/NO-004/NO; EU/1/98/077/006/NO-008/NO; EU/1/98/077/010/NO-019/NO Viagra Norway 24.9.2008 EU/1/98/077/002-004, 006-008, 010-019/IS Viagra Iceland 25.10.2008 EU/1/98/080/001 Aldara Liechtenstein 31.10.2008 EU/1/98/080/001/IS Aldara Iceland 19.11.2008 EU/1/98/080/001/NO Aldara Norway 9.10.2008 EU/1/98/081/001/NO-004/NO Comtan Norway 29.9.2008 EU/1/98/081/001-004 Comtan Liechtenstein 31.10.2008 EU/1/98/081/001-004/IS Comtan Iceland 21.10.2008 EU/1/98/082/001/NO-003/NO; EU/1/98/082/005/NO Comtess Norway 29.9.2008 EU/1/98/082/001-003, 005 Comtess Liechtenstein 31.10.2008 EU/1/98/082/001-003, 005/IS Comtess Iceland 21.10.2008 EU/1/98/084/001/NO-002/NO Simulect Norway 11.11.2008 EU/1/98/084/001-002 Simulect Liechtenstein 31.10.2008 EU/1/98/084/001-002/IS Simulect Iceland 7.11.2008 EU/1/98/085/001/NO-034/NO Karvezide Norway 28.10.2008 EU/1/98/085/001-034 Karvezide Liechtenstein 31.12.2008 EU/1/98/085/001-034/IS Karvezide Iceland 28.10.2008 EU/1/98/086/001/NO-034/NO CoAprovel Norway 28.10.2008 EU/1/98/086/001-034 CoAprovel Liechtenstein 31.12.2008 EU/1/98/086/001-034/IS CoAprovel Iceland 28.10.2008 EU/1/98/089/001-022 Pritor Liechtenstein 31.12.2008 EU/1/98/089/001-022/IS Pritor Iceland 18.12.2008 EU/1/98/090/001-020 Micardis Liechtenstein 31.12.2008 EU/1/98/090/001-020/IS Micardis Iceland 18.12.2008 EU/1/98/091/001-014 Kinzalmono Liechtenstein 31.12.2008 EU/1/98/091/001-014/IS Kinzalmono Iceland 18.12.2008 EU/2/03/040/001-002/IS Gonazon Iceland 11.7.2008 EU/2/03/041/001-005 Draxxin Liechtenstein 31.10.2008 EU/2/03/041/001-005/IS Draxxin Iceland 27.10.2008 EU/2/98/009/001/NO-006/NO Suvaxyn Aujeszky Norway 18.12.2008 EU/2/98/009/001-006 Suvaxyn Aujeszky Liechtenstein 31.10.2008 EU/2/99/011/001 Locatim Liechtenstein 31.12.2008

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 2008: EU-Number Product Country Date of authorisation EU/1/01/183/030-032 HBVAXPRO Liechtenstein 31.10.2008 EU/1/01/195/022-027 Liprolog Liechtenstein 31.8.2008 EU/1/01/195/022-027/IS Liprolog Iceland 11.8.2008 EU/1/02/214/011/NO-015/NO Kinzalkomb Norway 15.9.2008 EU/1/02/215/015/NO-021/NO PritorPlus Norway 15.9.2008 EU/1/03/255/006 Ventavis Liechtenstein 31.8.2008 EU/1/03/267/010 Reyataz Liechtenstein 31.12.2008 EU/1/04/291/003 Raptiva Liechtenstein 31.10.2008 EU/1/04/291/003/NO Raptiva Norway 26.11.2008 EU/1/04/305/002 Truvada Liechtenstein 31.10.2008 EU/1/04/305/002/NO Truvada Norway 16.9.2008 EU/1/05/330/005/NO-011/NO Rotarix Norway 6.10.2008 EU/1/05/330/005-011 Rotarix Liechtenstein 31.10.2008 EU/1/05/330/005-011/IS Rotarix Iceland 27.9.2008 EU/1/05/331/038/NO-055/NO Neupro Norway 25.9.2008 EU/1/05/331/038-055 Neupro Liechtenstein 31.10.2008 EU/1/05/331/038-055/IS Neupro Iceland 15.10.2008 EU/1/06/343/006-007 Baraclude Liechtenstein 31.8.2008 EU/1/06/356/007-009 Exjade Liechtenstein 31.12.2008 EU/1/06/360/012 Champix Liechtenstein 31.8.2008 EU/1/06/368/088/NO-142/NO Insulin Human Winthrop Norway 28.11.2008 EU/1/06/368/088-142 Insulin Human Winthrop Liechtenstein 31.12.2008 EU/1/07/386/011-012 Toviaz Liechtenstein 31.8.2008 EU/1/07/386/013-016 Toviaz Liechtenstein 31.12.2008 EU/1/07/392/002 Circadin Liechtenstein 31.8.2008 EU/1/07/394/007-009 Optaflu Liechtenstein 31.8.2008 EU/1/07/400/017/NO-021/NO Mircera Norway 13.10.2008 EU/1/07/400/017-020/IS Mircera Iceland 17.10.2008 EU/1/07/400/017-021 Mircera Liechtenstein 31.10.2008 EU/1/07/410/017-020 Binocrit Liechtenstein 31.8.2008 EU/1/07/411/017-020 Epoetin alfa Hexal Liechtenstein 31.8.2008 EU/1/07/412/017-020 Abseamed Liechtenstein 31.8.2008 EU/1/07/414/018 Galvus Liechtenstein 31.10.2008 EU/1/07/419/010-012 Cervarix Liechtenstein 31.12.2008 EU/1/07/431/020/NO-025/NO Retacrit Norway 15.12.2008 EU/1/07/431/020-025 Retacrit Liechtenstein 31.12.2008 EU/1/07/432/020-022 Silapo Liechtenstein 31.8.2008 EU/1/95/003/007/NO-008/NO Betaferon Norway 13.11.2008 EU/1/95/003/007-008 Betaferon Liechtenstein 31.12.2008 EU/1/97/030/140/NO-169/NO Insuman Norway 1.12.2008 EU/1/97/030/140-169 Insuman Liechtenstein 31.12.2008 EU/102/206/021/NO-035/NO Arixtra Norway 8.9.2008 EU/102/206/021-035 Arixtra Liechtenstein 31.10.2008 EU/2/02/033/002 Dexdomitor Liechtenstein 31.8.2008 EU/2/05/054/018/NO-031/NO Profender Norway 24.9.2008 EU/2/05/054/018-031 Profender Liechtenstein 31.10.2008 EU/2/05/054/018-031/IS Profender Iceland 1.10.2008 EU/2/06/058/004 Flexicam Liechtenstein 31.12.2008 EU/2/99/015/002 Oxyglobin Liechtenstein 31.10.2008

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 2008: EU-Number Product Country Date of withdrawal EU/1/01/184/001-073 Nespo Liechtenstein 31.12.2008 EU/1/01/185/023-030 Aranesp Liechtenstein 31.12.2008 EU/1/02/202/001-006 Protopy Liechtenstein 31.10.2008 EU/1/02/202/001-006/IS Protopy Iceland 27.9.2008 EU/1/02/228/001-003 Neupopeg Liechtenstein 31.12.2008 EU/1/04/293/001-012 Parareg Liechtenstein 31.12.2008 EU/1/04/301/001/NO-005/NO Quintanrix Norway 25.11.2008 EU/1/04/301/001-005 Quintanrix Liechtenstein 31.10.2008 EU/1/04/301/001-005/IS Quintanrix Iceland 27.9.2008 EU/1/05/327/001/NO-018/NO Exubera Norway 25.11.2008 EU/1/05/327/001-018 Exubera Liechtenstein 31.10.2008 EU/1/05/327/001-018/IS Exubera Iceland 22.10.2008 EU/1/98/093/002 Forcaltonin Liechtenstein 31.12.2008 EU/1/98/093/002/IS Forcaltonin Iceland 29.11.2008 EU/1/98/093/002/NO Forcaltonin Norway 25.11.2008 EU/1/99/128/001/NO-037/NO Viraferon Norway 29.10.2008 EU/1/99/128/001-037 Viraferon Liechtenstein 31.10.2008 EU/1/99/128/001-037/IS Viraferon Iceland 22.10.2008