EN Official Journal of the European Union C 52/11

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

(2009/C 52/05)

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 January-30 June 2008, at their meeting on 7 November 2008:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations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 I List of new marketing authorisations The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2008: EU-Number Product Country Date of authorisation EU/1/05/312/001 Xyrem Liechtenstein 30.6.2008 EU/1/06/334/001-004 Evoltra Liechtenstein 30.6.2008 EU/1/06/370/001-024 Exforge Liechtenstein 30.6.2008 EU/1/06/371/001-024 Dafiro Liechtenstein 30.6.2008 EU/1/06/372/001-024 Copalia Liechtenstein 30.6.2008 EU/1/06/373/001-024 Imprida Liechtenstein 30.6.2008 EU/1/07/001-019/IS Retacrit Iceland 16.1.2008 EU/1/07/393/001 Soliris Liechtenstein 30.6.2008 EU/1/07/400/001-016 Mircera Liechtenstein 30.6.2008 EU/1/07/402/001/NO Increlex Norway 31.1.2008 EU/1/07/421/001-009/IS Pioglitazone Iceland 9.1.2008 EU/1/07/422/001/NO-004/NO Tasigna Norway 17.1.2008 EU/1/07/422/001-004 Tasigna Liechtenstein 30.6.2008 EU/1/07/423/001/NO-003/NO Vectibix Norway 21.1.2008 EU/1/07/423/001-003 Vectibix Liechtenstein 30.6.2008 EU/1/07/423/001-003/IS Vectibix Iceland 28.1.2008 EU/1/07/427/001/NO-037/NO Olanzapine Teva Norway 7.1.2008 EU/1/07/427/001-047/IS Olanzapine Teva Iceland 7.1.2008 EU/1/07/428/001 Abraxane Liechtenstein 29.2.2008 EU/1/07/428/001/IS Abraxane Iceland 24.1.2008 EU/1/07/428/001/NO Abraxane Norway 21.1.2008 EU/1/07/430/001 Atripla Liechtenstein 30.6.2008 EU/1/07/430/001/IS Atripla Iceland 28.1.2008 EU/1/07/430/001/NO Atripla Norway 29.1.2008 EU/1/07/431/001/NO-019/NO Retacrit Norway 17.1.2008 EU/1/07/431/001-019 Retacrit Liechtenstein 30.6.2008 EU/1/07/432/001/NO-019/NO Silapo Norway 17.1.2008 EU/1/07/432/001-019 Silapo Liechtenstein 29.2.2008 EU/1/07/432/001-019/IS Silapo Iceland 16.1.2008 EU/1/07/433/001/IS Nevanac Iceland 8.1.2008 EU/1/07/434/001/NO-003/NO Avamys Norway 23.1.2008 EU/1/07/434/001-003 Avamys Liechtenstein 29.2.2008 EU/1/07/434/001-003/IS Avamys Iceland 25.1.2008 EU/1/07/435/001/NO-018/NO Tesavel Norway 24.1.2008 EU/1/07/435/001-018 Tesavel Liechtenstein 30.4.2008 EU/1/07/435/001-018/IS Tesavel Iceland 24.1.2008 EU/1/07/436/001/NO-002/NO Isentress Norway 16.1.2008 EU/1/07/436/001-002 Isentress Liechtenstein 29.2.2008 EU/1/07/436/001-002/IS Isentress Iceland 18.1.2008 EU/1/07/437/001/NO-002/NO Ivemend Norway 31.1.2008 EU/1/07/437/001-002 Ivemend Liechtenstein 29.2.2008 EU/1/07/437/001-002/IS Ivemend Iceland 22.1.2008 EU/1/07/438/001/NO-004/NO Myfenac Norway 14.3.2008 EU/1/07/438/001-004 Myfenax Liechtenstein 30.4.2008 EU/1/07/438/001-004/IS Myfenax Iceland 17.3.2008 EU/1/07/439/001/NO-004/NO Mycophenolate mofetil Teva Norway 14.3.2008 EU/1/07/439/001-004 Mycophenolate mofetil Teva Liechtenstein 30.4.2008 EU/1/07/439/001-004/IS Mycophenolate mofetil Teva Iceland 17.3.2008 EU/1/07/440/001/NO-002/NO Tyverb Norway 17.6.2008 EU/1/07/440/001-002/IS Tyverb Iceland 26.6.2008 EU/1/08/441/001/NO-010/NO Effentora Norway 15.4.2008 EU/1/08/441/001-010 Effentora Liechtenstein 30.4.2008 EU/1/08/441/001-010/IS Effentora Iceland 17.4.2008 EU/1/08/442/001/NO-008/NO Pradaxa Norway 14.4.2008 EU/1/08/442/001-008 Pradaxa Liechtenstein 30.4.2008 EU/1/08/442/001-008/IS Pradaxa Iceland 26.3.2008 EU/1/08/443/001 Thalidomide Pharmion Liechtenstein 30.4.2008 EU/1/08/443/001/IS Thalidomide Pharmion Iceland 21.4.2008 EU/1/08/443/001/NO Thalidomide Pharmion Norway 16.5.2008 EU/1/08/446/001/NO-003/NO Privigen Norway 19.5.2008 EU/1/08/446/001-003 Privigen Liechtenstein 30.6.2008 EU/1/08/446/001-003/IS Privigen Iceland 23.5.2008 EU/1/08/447/001/NO-004/NO Adenuric Norway 24.6.2008 EU/1/08/447/001-004 Adenuric Liechtenstein 30.4.2008 EU/1/08/447/001-004/IS Adenuric Iceland 16.5.2008 EU/1/08/448/001/NO-002/NO Mycamine Norway 21.5.2008 EU/1/08/448/001-002 Mycamine Liechtenstein 30.4.2008 EU/1/08/448/001-002/IS Mycamine Iceland 28.5.2008 EU/1/08/451/001/NO-004/NO Volibris Norway 29.4.2008 EU/1/08/451/001-002/IS Volibris Iceland 21.5.2008 EU/1/08/451/001-004 Volibris Liechtenstein 30.4.2008 EU/1/08/452/001 Pandemrix Liechtenstein 30.6.2008 EU/1/08/452/001/IS Pandemrix Iceland 23.5.2008 EU/1/08/452/001/NO Pandemrix Norway 20.5.2008 EU/1/08/453/001 Prepandrix Liechtenstein 30.6.2008 EU/1/08/453/001/IS Prepandrix Iceland 23.5.2008 EU/1/08/454/001/NO-004/NO Extavia Norway 3.6.2008 EU/1/08/454/001-004 Extavia Liechtenstein 30.6.2008 EU/1/08/454/001-004/IS Extavia Iceland 30.5.2008 EU/2//08/081/001-003 Posatex Liechtenstein 30.6.2008 EU/2/04/044/007/IS Aivlosin Iceland 19.6.2008 EU/2/07/073/001/NO-004/NO Nobilis Influenza H7N1 Norway 4.1.2008 EU/2/07/076/001/NO-004/NO Nobilis Influenza H5N6 Norway 13.3.2008 EU/2/07/076/001-004 Nobilis Influenza H5N6 Liechtenstein 29.2.2008 EU/2/07/077/001/NO-005/NO Meloxivet Norway 7.2.2008 EU/2/07/077/001-004/IS Meloxivet Iceland 27.6.2008 EU/2/07/078/001/NO-003/NO Rheumocam Norway 25.2.2008 EU/2/07/078/001-002/IS Rheumocam Iceland 25.1.2008 EU/2/07/078/001-003 Rheumocam Liechtenstein 29.2.2008 EU/2/07/079/001/NO-004/NO Ingelvac CircoFLEX Norway 26.3.2008 EU/2/07/079/001-004 Ingelvac CircoFLEX Liechtenstein 29.2.2008 EU/2/07/079/001-004/IS Ingelvac CircoFLEX Iceland 19.3.2008

ANNEX II List of renewed marketing authorisations The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2008: EU-Number Product Country Date of authorisation EU/1/02/246/001/NO-003/NO Carbaglu Norway 30.5.2008 EU/1/02/246/001-003 Carbaglu Liechtenstein 30.6.2008 EU/1/02/246/001-003/IS Carbaglu Iceland 29.5.2008 EU/1/03/247/001/NO-002/NO Forsteo Norway 1.7.2008 EU/1/03/247/001-002 Forsteo Liechtenstein 30.6.2008 EU/1/03/247/001-002/IS Forsteo Iceland 21.5.2008 EU/1/03/248/001/NO-012/NO Levitra Norway 25.2.2008 EU/1/03/248/001-012/IS Levitra Iceland 19.2.2008 EU/1/03/249/001/NO-012/NO Vivanza Norway 25.2.2008 EU/1/03/249/001-012 Vivanza Liechtenstein 29.2.2008 EU/1/03/249/001-012/IS Vivanza Iceland 19.2.2008 EU/1/03/250/001 Ytracis Liechtenstein 29.2.2008 EU/1/03/250/001/IS Ytracis Iceland 28.2.2008 EU/1/03/250/001/NO Ytracis Norway 25.2.2008 EU/1/03/251/001/NO-002/NO Hepsera Norway 4.4.2008 EU/1/03/251/001-002 Hepsera Liechtenstein 30.4.2008 EU/1/03/251/001-002/IS Hepsera Iceland 10.4.2008 EU/1/03/253/001/NO-003/NO Aldurazyme Norway 30.5.2008 EU/1/03/253/001-003 Aldurazyme Liechtenstein 30.6.2008 EU/1/03/253/001-003/IS Aldurazyme Iceland 22.5.2008 EU/1/06/367/001/NO-012/NO Diacomit Norway 7.1.2008 EU/1/06/367/001-012 Diacomit Liechtenstein 29.2.2008 EU/1/06/367/001-012/IS Diacomit Iceland 7.1.2008 EU/1/06/380/001 Prezista Liechtenstein 29.2.2008 EU/1/06/380/001/IS Prezista Iceland 22.1.2008 EU/1/06/380/001/NO Prezista Norway 21.1.2008 EU/1/97/045/001-004 Helicobacter Test INFAI Liechtenstein 30.4.2008 EU/1/97/045/001-004/IS Helicobacter Test INFAI Iceland 9.4.2008 EU/1/97/054/001&004-005/IS Viracept Iceland 21.1.2008 EU/1/97/054/001, 004-005 Viracept Liechtenstein 29.2.2008 EU/1/97/054/001/NO, 004/NO-005/NO Viracept Norway 17.1.2008 EU/1/97/055/001/NO-003/NO Viramune Norway 21.1.2008 EU/1/97/055/001-003 Viramune Liechtenstein 30.4.2008 EU/1/97/055/001-003/IS Viramune Iceland 22.1.2008 EU/1/97/057/001/IS Quadramet Iceland 7.1.2008 EU/1/97/057/001/NO Quadramet Norway 17.1.2008 EU/1/98/058/001/NO-002/NO Combivir Norway 26.2.2008 EU/1/98/058/001-002 Combivir Liechtenstein 29.2.2008 EU/1/98/058/001-002/IS Combivir Iceland 12.3.2008 EU/1/98/063/001/NO-006/NO Rebif Norway 3.6.2008 EU/1/98/063/001-007 Rebif Liechtenstein 30.6.2008 EU/1/98/063/001-007/IS Rebif Iceland 2.6.2008 EU/1/98/065/001-002 Otpison Liechtenstein 30.6.2008 EU/1/98/066/001/NO-026/NO Exelon Norway 3.6.2008 EU/1/98/066/001-026 Exelon Liechtenstein 30.6.2008 EU/1/98/066/001-026/IS Exelon Iceland 29.5.2008 EU/1/98/067/001/NO-002/NO MabThera Norway 24.6.2008 EU/1/98/067/001-002 Mabthera Liechtenstein 30.6.2008 EU/1/98/067/001-002/IS MabThera Iceland 29.5.2008 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/1/98/069/001a-001b, 002a-002b, 003a-003b, -004a-004b, 005a-005b, 006a-006b, 007a-007b, 008-010 Plavix Liechtenstein 30.6.2008 EU/1/98/069/001a-007a& 001b-007b&008-010/IS Plavix Iceland 27.6.2008 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/1/98/070/001a-001b, 002a-002b, 003a-003b, -004a-004b, 005a-005b, 006a-006b, 007a-007b, 008-010 Iscover Liechtenstein 30.6.2008 EU/1/98/070/001a-007a& 001b-007b&008-010/IS Iscover Iceland 27.6.2008 EU/1/98/071/001-006 Xenical Liechtenstein 30.6.2008 EU/1/98/092/001/NO-023/NO Prometax Norway 3.6.2008 EU/1/98/092/001-026 Prometax Liechtenstein 30.6.2008 EU/1/98/092/001-026/IS Prometax Iceland 16.6.2008 EU/2/02/032/001/NO Vaxxitek HVT + IBD Norway 24.1.2008 EU/2/02/033/001/NO Dexdomitor Norway 21.1.2008 EU/2/02/034/001/NO Nobivac Bb for cats Norway 24.1.2008 EU/2/02/035/001/NO-007/NO SevoFlo Norway 17.1.2008 EU/2/02/036/001/NO-002/NO Nobilis OR inac Norway 26.2.2008 EU/2/02/036/001-002 Nobilis OR inac Liechtenstein 30.4.2008 EU/2/02/036/001-002/IS Nobilis OR inac Iceland 21.1.2008 EU/2/03/037/005 ProteqFlu Liechtenstein 29.2.2008 EU/2/03/037/005/IS ProteqFlu Iceland 21.1.2008 EU/2/03/037/005/NO ProteqFlu Norway 27.3.2008 EU/2/03/038/005 ProteqFlu-Te Liechtenstein 29.2.2008 EU/2/03/038/005/IS ProteqFlu-Te Iceland 21.1.2008 EU/2/03/038/005/NO ProteqFlu Te Norway 27.3.2008 EU/2/03/039/001/NO-030/NO Advocate Norway 22.4.2008 EU/2/03/039/001-004&013-14&019-022/IS Advocate for cats Iceland 13.3.2008 EU/2/03/039/001-030 Advocate Liechtenstein 29.2.2008 EU/2/03/039/005-012&015-018&023-030/IS Advocate for dogs Iceland 13.3.2008 EU/2/03/040/001-002 Gonazon Liechtenstein 30.6.2008 EU/2/96/002/001/NO-003/NO Fevaxyn Pentofel Norway 12.2.2008 EU/2/97/001-018/IS Dicural Iceland 21.1.2008 EU/2/97/003/001/NO-018/NO Dicural Norway 25.2.2008 EU/2/97/003/001-018 Dicural Liechtenstein 29.2.2008 EU/2/97/004/001&010/IS Metacam for cattle and pigs Iceland 4.1.2008 EU/2/97/004/003-005&012-013&016-025&029/IS Metacam for dogs Iceland 4.1.2008 EU/2/97/004/006&011/IS Metacam for dogs and cats Iceland 4.1.2008 EU/2/97/004/007-008&014-015&027-028&031-032/IS Metacam for cattle, pigs and horses Iceland 4.1.2008 EU/2/97/004/009&030/IS Metacam for horses Iceland 4.1.2008 EU/2/97/004/026/IS Metcam for cats Iceland 4.1.2008 EU/2/98/006/001-010 Nobilis IB 4-91 Liechtenstein 30.6.2008 EU/2/98/006/001-010/IS Nobilis IB 4-91 Iceland 23.5.2008 EU/2/98/007/001/NO-003/NO Clomicalm Norway 26.5.2008 EU/2/98/007/001-003 Clomicalm Liechtenstein 30.4.2008 EU/2/98/007/001-003/IS Clomicalm Iceland 21.4.2008 EU/2/98/008/001/NO-004/NO Neocolipor Norway 21.4.2008 EU/2/98/008/001-004 Neocolipor Liechtenstein 30.4.2008 EU/2/98/008/001-004/IS Neocolipor Iceland 9.4.2008

ANNEX III List of extended marketing authorisations The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2008: EU-Number Product Country Date of extention EU/1/00/143/010/NO-011/NO Kogenate Bayer Norway 28.1.2008 EU/1/00/143/010-011 Kogenate Bayer Liechtenstein 29.2.2008 EU/1/00/143/010-011/IS Kogenate Bayer Iceland 16.1.2008 EU/1/00/144/004 Helixate NexGen Liechtenstein 29.2.2008 EU/1/00/144/004/IS Helixate NexGen Iceland 16.1.2008 EU/1/00/144/004/NO Helixate NexGen Norway 28.1.2008 EU/1/00/167/008 Prevenar Liechtenstein 30.6.2008 EU/1/01/172/006 Kaletra Liechtenstein 30.4.2008 EU/1/01/172/006/IS Kaletra Iceland 14.4.2008 EU/1/01/172/006/NO Kaletra Norway 14.4.2008 EU/1/01/195/016/NO-021/NO Liprolog Norway 29.1.2008 EU/1/01/195/016-021 Liprolog Liechtenstein 29.2.2008 EU/1/01/200/002 Viread Liechtenstein 30.4.2008 EU/1/01/200/002/NO Viread Norway 23.4.2008 EU/1/02/213/017-023 MicardisPlus Liechtenstein 30.4.2008 EU/1/02/213/017/NO-023/NO MicardisPlus Norway 27.5.2008 EU/1/02/213/017-023/IS MicardisPlus Iceland 15.4.2008 EU/1/02/214/011-015 Kinzalcomb Liechtenstein 30.4.2008 EU/1/02/215/015-021 Pritor Plus Liechtenstein 30.4.2008 EU/1/02/218/012-029 Axura Liechtenstein 30.6.2008 EU/1/02/218/012-029/IS Axura Iceland 28.5.2008 EU/1/02/218/016/NO-023/NO Axura Norway 27.5.2008 EU/1/02/219/016-021 Ebixa Liechtenstein 30.4.2008 EU/1/02/219/022/NO-049/NO Ebixa Norway 21.5.2008 EU/1/02/219/022-049 Ebixa Liechtenstein 30.6.2008 EU/1/02/219/022-049/IS Ebixa Iceland 27.5.2008 EU/1/03/260/019/NO-023/NO Stalevo Norway 27.5.2008 EU/1/03/260/019-023 Stalevo Liechtenstein 30.4.2008 EU/1/03/260/019-023/IS Stalevo Iceland 20.5.2008 EU/1/03/267/008/NO-009/NO Reyataz Norway 16.5.2008 EU/1/03/267/008-009 Reyataz Liechtenstein 30.4.2008 EU/1/03/267/008-009/IS Reyataz Iceland 22.4.2008 EU/1/03/268/004 Cholestagel Liechtenstein 30.6.2008 EU/1/03/271/001-006/IS Advate Iceland 30.5.2008 EU/1/03/271/005/NO-006/NO Advate Norway 3.6.2008 EU/1/03/271/005-006 Advate Liechtenstein 30.6.2008 EU/1/04/274/002 Velcade Liechtenstein 30.4.2008 EU/1/04/274/002/NO Velcade Norway 21.4.2008 EU/1/04/279/036-043 Lyrica Liechtenstein 29.2.2008 EU/1/04/283/008/NO-012/NO Ariclaim Norway 17.1.2008 EU/1/04/283/008-012/IS Ariclaim Iceland 15.2.2008 EU/1/04/298/003 Kivexa Liechtenstein 30.4.2008 EU/1/04/298/003/NO Kivexa Norway 29.2.2008 EU/1/06/357/018-021 Gardasil Liechtenstein 30.4.2008 EU/1/06/358/018-021 Silgard Liechtenstein 30.4.2008 EU/1/06/366/017/NO-022/NO Tandemact Norway 22.4.2008 EU/1/06/366/017-022 Tandemact Liechtenstein 30.4.2008 EU/1/06/366/017-022/IS Tandemact Iceland 16.4.2008 EU/1/06/368/058-087 Insulin Human Winthrop Liechtenstein 29.2.2008 EU/1/06/370/025-033 Exforge Liechtenstein 30.6.2008 EU/1/06/371/025-033 Dafiro Liechtenstein 30.6.2008 EU/1/06/372/025-033 Copalia Liechtenstein 30.6.2008 EU/1/06/373/025-033 Imprida Liechtenstein 30.6.2008 EU/1/07/387/009/NO-010/NO Advagraf Norway 25.1.2008 EU/1/07/387/009-010 Advagraf Liechtenstein 29.2.2008 EU/1/07/388/002 Sebivo Liechtenstein 29.2.2008 EU/1/07/388/002/NO Sebivo Norway 28.2.2008 EU/1/96/006/004/NO-006/NO NovoSeven Norway 21.5.2008 EU/1/96/006/004-006 NovoSeven Liechtenstein 30.4.2008 EU/1/96/006/004-006/IS NovoSeven Iceland 22.5.2008 EU/1/96/007/031/NO-038/NO Humalog Norway 31.1.2008 EU/1/96/007/031-038 Humalog Liechtenstein 29.2.2008 EU/1/96/027/006/NO-007/NO Hycamtin Norway 9.4.2008 EU/1/96/027/006-007 Hycamtin Liechtenstein 30.4.2008 EU/1/96/027/006-007/IS Hycamtin Iceland 26.3.2008 EU/1/97/030/085-139 Insuman Liechtenstein 29.2.2008 EU/1/98/069/008/NO-010/NO Plavix Norway 22.4.2008 EU/1/98/069/008-010 Plavix Liechtenstein 30.4.2008 EU/1/98/069/008-010/IS Plavix Iceland 17.4.2008 EU/1/98/070/008/NO-010/NO Iscover Norway 19.5.2008 EU/1/98/070/008-010 Iscover Liechtenstein 30.4.2008 EU/1/98/070/008-010/IS Iscover Iceland 17.4.2008 EU/1/99/119/015 NovoRapid Liechtenstein 30.4.2008 EU/1/99/119/015/NO NovoRapid Norway 25.2.2008 EU/2/04/044/007 Aivlosin Liechtenstein 30.6.2008 EU/2/04/045/007/NO Previcox Norway 29.1.2008 EU/2/97/004/031-032 Metacam Liechtenstein 30.6.2008