DA Den Europæiske Unions Tidende C 266/7

Medicinske specialiteter — Liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i første halvdel af 2006

(2007/C 266/05)

Underudvalg I — For frie varebevægelser

Under henvisning til afgørelse truffet af Det Blandede EØS-udvalg (EF) nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-udvalg til på sit møde den 8. december 2006 at notere sig følgende lister over markedsføringstilladelser for medicinske specialiteter udstedt i perioden 1. januar-30. juni 2006:

BILAG I Liste over nye markedsføringstilladelser BILAG II Liste over fornyede markedsføringstilladelser BILAG III Liste over udvidede 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. januar-30. juni 2006: EU-nummer Produkt Land Udstedelsesdato EU/1/01/183/020-029 HBVAXPRO Liechtenstein 28.2.2006 EU/1/01/187/001 DepoCyte Liechtenstein 31.1.2006 EU/1/03/258/015-022 Avandamet Liechtenstein 28.2.2006 EU/1/03/262/001-006 Emend Liechtenstein 31.1.2006 EU/1/03/265/003-004 Bonviva Liechtenstein 31.1.2006 EU/1/03/266/001-002 Bondenza Liechtenstein 28.2.2006 EU/1/04/307/005-010 Zonegran Liechtenstein 31.1.2006 EU/1/05/322/001 Yttriga Liechtenstein 31.1.2006 EU/1/05/322/001/IS Yttriga Island 17.2.2006 EU/1/05/322/001/NO Yttriga Norge 10.2.2006 EU/1/05/323/001/NO-011/NO ProQuad Norge 24.4.2006 EU/1/05/323/001-011 ProQuad Liechtenstein 30.4.2006 EU/1/05/323/001-011/IS ProQuad Island 25.4.2006 EU/1/05/324/001 Naglazyme Liechtenstein 31.1.2006 EU/1/05/324/001/IS Naglazyme Island 22.6.2006 EU/1/05/324/01/NO Naglazyme Norge 23.2.2006 EU/1/05/325/001 Macugen Liechtenstein 28.2.2006 EU/1/05/325/001/IS Macugen Island 10.3.2006 EU/1/05/325/001/NO Macugen Norge 2.3.2006 EU/1/05/326/001 Ionsys Liechtenstein 31.1.2006 EU/1/05/326/001/IS Ionsys Island 22.2.2006 EU/1/05/326/001/NO Ionsys Norge 16.2.2006 EU/1/05/327/001/NO-017/NO Exubera Norge 16.2.2006 EU/1/05/327/001-017 Exubera Liechtenstein 31.1.2006 EU/1/05/327/001-017/IS Exubera Island 22.3.2006 EU/1/05/328/001/NO-002/NO Cubicin Norge 16.2.2006 EU/1/05/328/001-002 Cubicin Liechtenstein 28.2.2006 EU/1/05/328/001-002/IS Cubicin Island 13.2.2006 EU/1/05/329/001/NO-005/NO Kiovig Norge 27.1.2006 EU/1/05/329/001-005 Kiovig Liechtenstein 31.1.2006 EU/1/05/329/001-005/IS Kiovig Island 10.2.2006 EU/1/05/330/001/NO-004/NO Rotarix Norge 8.3.2006 EU/1/05/330/001-004 Rotarix Liechtenstein 28.2.2006 EU/1/05/330/001-004/IS Rotarix Island 27.4.2006 EU/1/05/331/001/NO-013/NO Neupro Norge 17.3.2006 EU/1/05/331/001-013 Neupro Liechtenstein 28.2.2006 EU/1/05/331/001-013/IS Neupro Island 10.4.2006 EU/1/06/332/001/NO-003/NO Omnitrope Norge 5.5.2006 EU/1/06/332/001-003 Omnitrope Liechtenstein 30.4.2006 EU/1/06/332/001-003/IS Omnitrope Island 11.5.2006 EU/1/06/333/001/NO-003/NO Myozyme Norge 8.5.2006 EU/1/06/333/001-003 Myozyme Liechtenstein 30.4.2006 EU/1/06/334/001/NO-004/NO Evoltra Norge 27.6.2006 EU/1/06/334/001-004/IS Evoltra Island 26.6.2006 EU/1/06/335/001 Valtropin Liechtenstein 30.6.2006 EU/1/06/335/001/IS Valtropin Island 12.5.2006 EU/1/06/335/001/NO Valtropin Norge 24.5.2006 EU/1/06/336/001 Tygacil Liechtenstein 30.6.2006 EU/1/06/336/001/IS Tygacil Island 1.6.2006 EU/1/06/336/001/NO Tygacil Norge 24.5.2006 EU/1/06/337/001/NO-013/NO M-M-Rvaxpro Norge 19.5.2006 EU/1/06/337/001-013 M-M-Rvaxpro Liechtenstein 30.6.2006 EU/1/06/337/001-013/IS M-M-Rvaxpro Island 13.6.2006 EU/1/06/338/001/NO-003/NO DuoTrav Norge 10.5.2006 EU/1/06/338/001-003 DuoTrav Liechtenstein 30.6.2006 EU/1/06/338/001-003/IS DuoTrav Island 12.5.2006 EU/1/06/339/001/NO-002/NO Preotact Norge 19.5.2006 EU/1/06/339/001-002 Preotact Liechtenstein 30.6.2006 EU/1/06/339/001-002/IS Preotact Island 18.5.2006 EU/1/06/340/001/NO-002/NO Ganfort Norge 1.6.2006 EU/1/06/340/001-002 Ganfort Liechtenstein 30.6.2006 EU/1/06/340/001-002/IS Ganfort Island 15.6.2006 EU/1/06/341/001/NO-013/NO Zostavax Norge 6.6.2006 EU/1/06/341/001-013 Zostavax Liechtenstein 30.6.2006 EU/1/06/341/001-013/IS Zostavax Island 19.6.2006 EU/1/06/344/001/NO-009/NO Acomplia Norge 30.6.2006 EU/1/06/344/001-009 Acomplia Liechtenstein 30.6.2006 EU/1/06/345/001/NO-009/NO Zimulti Norge 30.6.2006 EU/1/06/345/001-009 Zimulti Liechtenstein 30.6.2006 EU/1/96/022/019-022 Zyprexa Liechtenstein 31.1.2006 EU/1/97/043/003 Revasc Liechtenstein 31.1.2006 EU/1/97/044/007-008 Tasmar Liechtenstein 28.2.2006 EU/1/97/046/031-033 Aprovel Liechtenstein 31.1.2006 EU/1/97/049/031-033 Karvea Liechtenstein 31.1.2006 EU/1/97/055/003 Viramune Liechtenstein 31.1.2006 EU/1/98/063/007 Rebif Liechtenstein 31.1.2006 EU/2/00/025/001-004 Advasure Liechtenstein 28.2.2006 EU/2/03/037/005 ProteqFlu Liechtenstein 28.2.2006 EU/2/03/038/005 ProteqFlu Te Liechtenstein 28.2.2006 EU/2/04/043/001 Equilis StrepE Liechtenstein 31.1.2006 EU/2/04/044/001 Aivlosin Liechtenstein 31.1.2006 EU/2/04/044/002-005 Aivlosin Liechtenstein 28.2.2006 EU/2/06/058/001/NO-003/NO Flexicam Norge 3.5.2006 EU/2/06/058/001-003 Flexicam Liechtenstein 30.4.2006 EU/2/06/058/001-003/IS Flexicam Island 22.4.2006 EU/2/06/059/001 Convenia Liechtenstein 30.6.2006 EU/2/97/004/014-015 Metacam Liechtenstein 28.2.2006

BILAG II Liste over fornyede markedsføringstilladelser Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne i perioden 1. januar -30. juni 2006: EU-nummer Produkt Land Fornyelsesdato EU/1/00/154/001/NO-002/NO Neospect Norge 27.2.2006 EU/1/00/154/001-002 NeoSpect Liechtenstein 28.2.2006 EU/1/00/154/001-002/IS NeoSpect Island 22.2.2006 EU/1/00/155/001/NO-006/NO Luveris Norge 27.2.2006 EU/1/00/155/001-006 Luveris Liechtenstein 31.1.2006 EU/1/00/155/001-006/IS Luveris Island 25.4.2006 EU/1/00/156/002/NO-003/NO Trizivir Norge 27.4.2006 EU/1/00/156/002-003 Trizivir Liechtenstein 30.4.2006 EU/1/00/157/001-034 Azomyr Liechtenstein 28.2.2006 EU/1/00/160/001-034 Aerius Liechtenstein 28.2.2006 EU/1/00/161/001-034 Neoclarityn Liechtenstein 28.2.2006 EU/1/00/163/001/NO Xeloda Norge 3.3.2006 EU/1/00/163/001-002 Xeloda Liechtenstein 28.2.2006 EU/1/00/163/001-002/IS Xeloda Island 7.3.2006 EU/1/00/163/002/NO Xeloda Norge 3.3.2006 EU/1/00/164/003/NO-006/NO NutropinAq Norge 20.4.2006 EU/1/00/164/003-005 NutropinAq Liechtenstein 30.4.2006 EU/1/00/164/003-005/IS NutropinAq Island 18.5.2006 EU/1/00/165/001/NO-007/NO Ovitrelle Norge 2.3.2006 EU/1/00/165/001-007 Ovitrelle Liechtenstein 28.2.2006 EU/1/00/165/007/IS Ovitrelle Island 11.4.2006 EU/1/00/166/001/NO-003/NO NeuroBloc Norge 3.5.2006 EU/1/00/166/001-003 NeuroBloc Liechtenstein 30.4.2006 EU/1/00/166/001-003/IS NeuroBloc Island 9.6.2006 EU/1/00/167/001/NO-007/NO Prevenar Norge 3.5.2006 EU/1/00/167/001-007 Prevenar Liechtenstein 30.4.2006 EU/1/00/167/001-007/IS Prevenar Island 30.5.2006 EU/1/00/169/002/NO-004/NO Metalyse Norge 14.3.2006 EU/1/00/169/004-006 Metalyse Liechtenstein 30.4.2006 EU/1/00/169/004-006/IS Metalyse Island 11.4.2006 EU/1/00/170/001/NO-002/NO Fasturtec Norge 27.2.2006 EU/1/00/170/001-002 Fasturtec Liechtenstein 28.2.2006 EU/1/00/170/001-002(IS Fasturtec Island 7.3.2006 EU/1/01/171/001,007-012/IS Rapamune Island 8.6.2006 EU/1/01/171/001/NO, 007/NO-012/NO Rapamune Norge 5.5.2006 EU/1/01/172/001/NO-003/NO Kaletra Norge 26.4.2006 EU/1/01/172/001-003 Kaletra Liechtenstein 30.4.2006 EU/1/01/172/001-003/IS Kaletra Island 23.5.2006 EU/1/01/173/001/NO-003/NO Vaniqa Norge 9.5.2006 EU/1/01/173/001-003 Vaniqa Liechtenstein 30.4.2006 EU/1/01/173/001-003/IS Vaniqa Island 7.6.2006 EU/1/01/174/001/NO-007/NO Starlix Norge 23.5.2006 EU/1/01/174/001-021 Starlix Liechtenstein 30.6.2006 EU/1/01/174/001-021/IS Starlix Island 7.6.2006 EU/1/01/175/001, 004-007, 008, 011-014, 015, 018-021/IS Trazec Island 7.6.2006 EU/1/01/175/001, 004-008, 011-015, 018-021 Trazec Liechtenstein 30.6.2006 EU/1/01/175/001/NO, 004/NO-007/NO, 008/NO, 011/NO-014/NO, 015/NO, 018/NO-021/NO Trazec Norge 23.5.2006 EU/1/01/176/001/NO-003/NO Zometa Norge 2.5.2006 EU/1/01/176/001-006 Zometa Liechtenstein 30.6.2006 EU/1/01/176/001-006/IS Zometa Island 22.5.2006 EU/1/01/177/001/NO-002/NO SonoVue Norge 4.5.2006 EU/1/01/177/001-002 SonoVue Liechtenstein 30.4.2006 EU/1/01/177/002/IS SonoVue Island 8.6.2006 EU/1/01/178/001/IS Targretin Island 9.6.2006 EU/1/01/178/001/NO Targretin Norge 16.5.2006 EU/1/01/179/001 Osigraft Liechtenstein 30.6.2006 EU/1/01/179/001/NO Osigraft Norge 30.5.2006 EU/1/01/184/001/NO-056/NO Nespo Norge 26.6.2006 EU/1/01/184/001-056 Nespo Liechtenstein 30.6.2006 EU/1/01/185/001/NO-056/NO Aranesp Norge 26.6.2006 EU/1/01/185/001-056 Aranesp Liechtenstein 30.6.2006 EU/1/01/187/001 DepoCyte Liechtenstein 30.6.2006 EU/1/01/195/001/NO-015 /NO Liprolog Norge 14.3.2006 EU/1/01/195/001-015 Liprolog Liechtenstein 28.2.2006 EU/1/01/195/001-015/IS Liprolog Island 13.3.2006 EU/1/03/262/007-008/IS Emend Island 19.6.2006 EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035 Gonal-f Liechtenstein 31.1.2006 EU/1/95/002/001/NO-002/NO Taxotere Norge 23.2.2006 EU/1/95/002/001-002 Taxotere Liechtenstein 31.1.2006 EU/1/95/002/001-002/IS Taxotere Island 23.2.2006 EU/1/95/003/003/NO-004/NO Betaferon Norge 2.3.2006 EU/1/95/003/003-004 Betaferon Liechtenstein 28.2.2006 EU/1/95/003/003-004/IS Betaferon Island 10.4.2006 EU/1/96/004/001/NO-002/NO Fareston Norge 1.3.2006 EU/1/96/004/001-002 Fareston Liechtenstein 28.2.2006 EU/1/96/005/001/NO-006/NO CellCept Norge 6.4.2006 EU/1/96/005/001-006 CellCept Liechtenstein 30.4.2006 EU/1/96/005/001-006/IS CellCept Island 5.5.2006 EU/1/96/006/001/NO-003/NO Novoseven Norge 3.3.2006 EU/1/96/006/001-003 NovoSeven Liechtenstein 28.2.2006 EU/1/96/006/001-003/IS NovoSeven Island 10.4.2006 EU/1/96/007/002, 004-006, 008, 010-011, 015-021, 023-030 Humalog Liechtenstein 30.4.2006 EU/1/96/007/002, 004-006, 008, 010-011, 015-021, 023-030/IS Humalog Island 13.3.2006 EU/1/96/007/002/NO, 004/NO-006/NO, 008/NO, 010/NO-011/NO, 015/NO-021/NO, 023/NO-030/NO Humalog Norge 3.3.2006 EU/1/96/008/001/NO-040/NO Puregon Norge 26.6.2006 EU/1/96/008/001-041 Puregon Liechtenstein 30.6.2006 EU/1/96/009/001/NO-002/NO Zerit Norge 2.5.2006 EU/1/96/009/001-009 Zerit Liechtenstein 30.4.2006 EU/1/96/009/001-009/IS Zerit Island 24.5.2006 EU/1/96/011/001/NO-004/NO Caelyx Norge 26.5.2006 EU/1/96/011/001-004 Caelyx Liechtenstein 30.6.2006 EU/1/96/011/001-004/IS Caelyx Island 16.6.2006 EU/1/98/093/002/IS Forcaltonin Island 31.5.2006 EU/1/98/093/002/NO Forcaltonin Norge 21.6.2006 EU/2/00/019/001-003/IS Purevax FeLV Island 9.3.2006 EU/2/00/025/001/NO-004/NO Advasure Norge 15.3.2006 EU/2/00/026/001/NO-004/NO Porcilis AR-T DF Norge 10.3.2006 EU/2/00/026/001-004 Porcilis AR-T DF Liechtenstein 28.2.2006 EU/2/00/026/001-004/IS Porcilis AR-T DF Island 8.3.2006 EU/2/00/027/001/NO-003/NO Pirsue Norge 10.3.2006 EU/2/00/027/001-003 Pirsue Liechtenstein 28.2.2006 EU/2/00/028/002/NO-008 /NO Zubrin Norge 7.4.2006 EU/2/00/028/002-008 Zubrin Liechtenstein 30.4.2006 EU/2/00/028/002-008/IS Zubrin Island 11.4.2006 EU/2/01/029/001/NO-003/NO Eurican Herpes Norge 18.5.2006 EU/2/01/029/001-003 Eurican Herpes Liechtenstein 30.4.2006 EU/2/01/029/001-003/IS Eurican Herpes Island 8.6.2006 EU/2/96/001/001-010 Porcilis Porcoli Liechtenstein 30.4.2006 EU/2/96/001/NO-010/NO Porcilis Porcoli Norge 5.5.2006

BILAG III Liste over udvidede markedsføringstilladelser Følgende markedsføringstilladelser er blevet udvidet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2006: EU-nummer Produkt Land Udvidelsesdato EU/1/00/137/013-018 Avandia Liechtenstein 30.6.2006 EU/1/00/146/030 Keppra Liechtenstein 30.4.2006 EU/1/00/146/030/IS Keppra Island 7.4.2006 EU/1/00/146/030/NO Keppra Norge 28.4.2006 EU/1/00/150/016-024 Actos Liechtenstein 30.4.2006 EU/1/00/151/014-022 Glustin Liechtenstein 30.4.2006 EU/1/00/162/019-021 Prandin Liechtenstein 30.6.2006 EU/1/03/255/004-005 Ventavis Liechtenstein 30.6.2006 EU/1/03/262/007/NO-008/NO Emend Norge 28.6.2006 EU/1/03/262/007-008 Emend Liechtenstein 30.6.2006 EU/1/03/262/007-008/IS Emend Island 19.6.2006 EU/1/03/265/005/NO-006/NO Bonviva Norge 2.5.2006 EU/1/03/265/005-006/IS Bonviva Island 12.6.2006 EU/1/03/266/005/NO-006/NO Bondenza Norge 8.5.2006 EU/1/04/279/033/NO-035/NO Lyrica Norge 19.6.2006 EU/1/04/279/033-035 Lyrica Liechtenstein 30.6.2006 EU/1/04/296/007 Cymbalta Liechtenstein 30.4.2006 EU/1/04/296/008 Cymbalta Liechtenstein 30.6.2006 EU/1/04/297/007 Xeristar Liechtenstein 30.4.2006 EU/1/04/297/008 Xeristar Liechtenstein 30.6.2006 EU/1/04/302/004 Prialt Liechtenstein 30.4.2006 EU/1/04/302/004/IS Prialt Island 22.4.2006 EU/1/04/302/004/NO Prialt Norge 29.3.2006 EU/1/05/319/003-004 Xolair Liechtenstein 30.6.2006 EU/1/96/007/029-030 Humalog Liechtenstein 30.4.2006 EU/1/98/063/007/IS Rebif Island 30.5.2006 EU/1/98/063/007/NO Rebif Norge 16.2.2006 EU/1/98/076/022-024 NovoNorm Liechtenstein 30.6.2006 EU/1/98/089/017-019 Pritor Liechtenstein 30.4.2006 EU/1/99/107/005 Rebetol Liechtenstein 30.4.2006 EU/2/00/019/005-007/IS Purevax FeL V Island 9.3.2006 EU/2/02/035/007 SevoFlo Liechtenstein 30.4.2006 EU/2/03/037/005/NO Proteqflu Norge 15.3.2006 EU/2/03/038/005/NO Proteqflu-Te Norge 15.3.2006 EU/2/04/044/002/NO Aivlosin Norge 4.3.2006 EU/2/04/044/003-005/IS Aivlosin Island 22.3.2006 EU/2/97/004/016/NO-023/NO Metacam Norge 22.4.2006 EU/2/97/004/016-023 Metacam Liechtenstein 30.4.2006 EU/2/97/004/016-023/IS Metacam Island 7.4.2006

BILAG IV Liste over tilbagetrukne markedsføringstilladelser Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne i perioden 1. januar-30. juni 2006: EU-nummer Produkt Land Tilbagetrækningsdato EU/1/00/137/001 Avandia Liechtenstein 30.6.2006 EU/1/01/183/002-003, 006, 009-010, 012, 014, 016-17 HBVAXPRO Liechtenstein 28.2.2006 EU/1/02/245/001 Theryttrex Liechtenstein 28.2.2006 EU/1/02/245/001/IS Theryttrex Island 10.2.2006 EU/1/06/024/006, 009 Crixivan Liechstenstein 31.1.2006 EU/1/96/022/001, 003, 005, 007, 013, 015 Zyprexa Liechstenstein 31.1.2006 EU/1/97/052/001/NO-006/NO, 009/NO-010/NO Daquiran Norge 22.2.2006 EU/1/97/052/001-006, 009-010 Daquiran Liechtenstein 28.2.2006 EU/1/97/052/001-010/IS Daquiran Island 10.2.2006 EU/1/98/075/001-002 Fortovase Liechtenstein 30.6.2006 EU/1/98/075/001-002/IS Fortovase- Saquinavir Island 26.6.2006 EU/1/98/087/001/NO-003/NO Infergen Norge 30.5.2006 EU/1/98/087/001-003 Infergen Liechtenstein 30.6.2006 EU/1/98/087/001-003/IS Infergen Island 16.6.2006 EU/2/00/028/001 Zubrin Liechtenstein 28.2.2006 EU/2/98/010/001-003, 015-016, 019-020 Econor Liechtenstein 31.1.2006