EN Official Journal of the European Union C 291/69

List of marketing authorisations granted by the EEA EFTA States for the second half of 2005

(2006/C 291/20)

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 2 June 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 June — 31 December 2005:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 1. New Marketing Authorisations: The following marketing authorisations have been granted in the EEA EFTA States during the period 1 June — 31 December 2005: EU-Number Product Country Date of authorisation EU/1/00/129/001-003 Azopt Liechtenstein 31.7.2005 EU/1/00/131/001-030 PegIntron Liechtenstein 30.9.2005 EU/1/00/134/008-011 Lantus Liechtenstein 30.9.2005 EU/1/00/135/002 DaTSCAN Liechtenstein 30.9.2005 EU/1/00/142/009-010 NovoMix Liechtenstein 30.9.2005 EU/1/00/142/011-016 NovoMix Liechtenstein 30.11.2005 EU/1/00/142/017-022 NovoMix Liechtenstein 30.11.2005 EU/1/01/198/007-010 Glivec Liechtenstein 31.7.2005 EU/1/02/215/001/NO-010/NO Pritor Plus Norway 7.9.2005 EU/1/02/227/003 Neulasta Liechtenstein 30.11.2005 EU/1/02/228/003 Neupopeg Liechtenstein 30.11.2005 EU/1/03/255/001-003 Ventavis Liechtenstein 30.11.2005 EU/1/03/258/013-014 Avandamet Liechtenstein 30.9.2005 EU/1/03/263/001-003/IS Dukoral, Suspension of vaccine and effervescent granules for oral solution Iceland 6.10.2005 EU/1/03/265/003-004 Bonviva Liechtenstein 30.9.2005 EU/1/03/266/003-004 Bondenza Liechtenstein 30.9.2005 EU/1/03/269/001 Faslodex Liechtenstein 30.11.2005 EU/1/03/270/003 Kentera Liechtenstein 31.7.2005 EU/1/04/276/021-032 Abilify Liechtenstein 31.7.2005 EU/1/04/276/033-035 Abilify Liechtenstein 30.11.2005 EU/1/04/279/030-032 Lyrica Liechtenstein 30.9.2005 EU/1/04/280/007 Yentreve Liechtenstein 30.9.2005 EU/1/04/283/007 Ariclaim Liechtenstein 30.9.2005 EU/1/04/289/002 Angiox Liechtenstein 31.7.2005 EU/1/04/296/005-006 Cymbalta Liechtenstein 31.7.2005 EU/1/04/297/005-006 Xeristar Liechtenstein 31.7.2005 EU/1/05/310/001/NO-005/NO Fosavance Norway 6.9.2005 EU/1/05/310/001-005 Fosavance Liechtenstein 30.9.2005 EU/1/05/310/001-005/IS Fosavance tablets Iceland 20.9.2005 EU/1/05/311/001/NO-003/NO Tarceva Norway 26.9.2005 EU/1/05/311/001-003 Tarceva Liechtenstein 30.9.2005 EU/1/05/311/001-003/IS Tarceva Iceland 18.10.2005 EU/1/05/312/001/IS Xyrem Iceland 18.11.2005 EU/1/05/312/001/NO Xyrem Norway 18.11.2005 EU/1/05/313/001/NO-009/NO Vasovist Norway 14.10.2005 EU/1/05/313/001-009 Vasovist Liechtenstein 30.11.2005 EU/1/05/313/001-009/IS Vasovist Iceland 2.11.2005 EU/1/05/314/001 Kepivance Liechtenstein 30.11.2005 EU/1/05/314/001/IS Kepivance Iceland 24.11.2005 EU/1/05/314/001/NO Kepivance Norway 22.11.2005 EU/1/05/315/001 Aptivus Liechtenstein 30.11.2005 EU/1/05/315/001/IS Aptivus Iceland 25.11.2005 EU/1/05/315/001/NO Aptivus Norway 2.11.2005 EU/1/05/316/001/NO-014/NO Procoralan Norway 10.11.2005 EU/1/05/316/001-014 Procoralan Liechtenstein 30.11.2005 EU/1/05/316/001-014/IS Procoralan Iceland 24.11.2005 EU/1/05/317/001/NO-014/NO Corlentor Norway 10.11.2005 EU/1/05/317/001-014 Corlentor Liechtenstein 30.11.2005 EU/1/05/317/001-014/IS Corlentor Iceland 24.11.2005 EU/1/05/318/001 Revatio Liechtenstein 30.11.2005 EU/1/05/318/001/IS Revatio Iceland 28.11.2005 EU/1/05/318/001/NO Revatio Norway 11.11.2005 EU/1/05/319/001/NO-002/NO Xolair Norway 7.11.2005 EU/1/05/319/001-002 Xolair Liechtenstein 30.11.2005 EU/1/05/319/001-002/IS Xolair Iceland 25.11.2005 EU/1/05/320/001 Noxafil Liechtenstein 30.11.2005 EU/1/05/320/001/IS Noxafil Iceland 20.11.2005 EU/1/05/320/001/NO Noxafil Norway 23.11.2005 EU/1/05/321/001 Posaconazole SP Liechtenstein 30.11.2005 EU/1/05/321/001/IS Posaconazole SP Iceland 24.11.2005 EU/1/05/321/001/NO Posaconazole SP Norway 23.11.2005 EU/2/01/030/003-004 Virbagen Omega Liechtenstein 30.9.2005 EU/2/04/047/001-002/IS Purevax RCPCh Fel V, powder and solv. for susp. for injection Iceland 30.6.2005 EU/2/04/048/001-002/IS Purevax RCP Fel V, powder and solv. for susp. for injection Iceland 30.6.2005 EU/2/04/049/001-002/IS Purevax RCCh, powder and solvent for suspension for injection Iceland 30.6.2005 EU/2/04/050/001-002/IS Purevax RCPCh, powder and solv. for susp. for injection Iceland 30.6.2005 EU/2/04/051/001-002/IS Purevax RC, powder and solvent for suspension for injection Iceland 30.6.2005 EU/2/04/052/001-002/IS Purevax RCP, powder and solvent for suspension for injection Iceland 30.6.2005 EU/2/05/053/001 Naxcel Liechtenstein 31.7.2005 EU/2/05/053/001/IS Naxcel, suspension for injection Iceland 9.6.2005 EU/2/05/053/001/NO Naxcel Norway 17.6.2005 EU/2/05/054/001/NO-017/NO Profender Norway 30.8.2005 EU/2/05/054/001-017 Profender Liechtenstein 30.9.2005 EU/2/05/054/001-017/IS Profender Spot-on solution Iceland 26.8.2005 EU/2/05/055/001/NO-002/NO Equilis Te Norway 12.8.2005 EU/2/05/055/001-002 Equilis Te Liechtenstein 30.9.2005 EU/2/05/055/001-002/IS Equilis Te, susp. for injection Iceland 2.8.2005 EU/2/05/056/001/NO-002/NO Equilis Prequenza Norway 12.8.2005 EU/2/05/056/001-002 Equilis Prequenza Liechtenstein 30.9.2005 EU/2/05/056/001-002/IS Equilis Prequenza, susp. for injection Iceland 2.08.2005 EU/2/05/057/001/NO-002/NO Equilis Prequenza Te Norway 12.8.2005 EU/2/05/057/001-002 Equilis Prequenza Te Liechtenstein 30.9.2005 EU/2/05/057/001-002/IS Equilis Prequenza Te, susp. for injection Iceland 2.8.2005 EU/2/97/004/011 Metacam Liechtenstein 31.7.2005 EU/2/97/004/012-013 Metacam Liechtenstein 30.9.2005

ANNEX II 2. Renewed Marketing Authorisations The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 June — 31 December 2005: EU-Number Product Country Date of renewal EU/1/00/129/001/NO-003/NO Azopt Norway 30.6.2005 EU/1/00/129/001-003/IS Azopt, eye drops, suspension, 1% Iceland 30.6.2005 EU/1/05/131/001/NO-005/NO PegIntron Norway 24.06.2005 EU/1/00/131/001-050/IS PegIntron Iceland 28.6.2005 EU/1/00/131/031-050 PegIntron Liechtenstein 30.9.2005 EU/1/05/132/001/NO-005/NO ViraferonPeg Norway 24.6.2005 EU/1/00/132/001-050 ViraferonPeg Liechtenstein 31.7.2005 EU/1/00/132/001-050/IS ViraferonPeg Iceland 28.6.2005 EU/1/00/133/001/NO-008/NO Optisulin Norway 27.7.2005 EU/1/00/133/001-008 Optisulin Liechtenstein 30.9.2005 EU/1/00/133/001-008/IS Optisulin Iceland 29.8.2005 EU/1/00/134/001/NO-029/NO Lantus Norway 27.7.2005 EU/1/00/134/001-007, 012-029 Lantus Liechtenstein 30.9.2005 EU/1/00/134/001-029/IS Lantus Iceland 29.8.2005 EU/1/00/135/001 DaTSCAN Liechtenstein 30.9.2005 EU/1/00/135/001/NO-002/NO DaTSCAN Norway 20.9.2005 EU/1/00/135/001-002/IS DaTSCAN Iceland 11.10.2005 EU/1/00/137/001/NO-012/NO Avandia Norway 27.7.2005 EU/1/00/137/001-012 Avandia Liechtenstein 30.9.2005 EU/1/00/137/001-012/IS Avandia Iceland 16.9.2005 EU/1/00/140/001 Visudyne Liechtenstein 31.7.2005 EU/1/00/140/001/IS Visudyne 15 mg Powder for solution for injection Iceland 14.7.2005 EU/1/00/140/001/NO Visudyne Norway 27.7.2005 EU/1/00/141/001 Myocet Liechtenstein 30.9.2005 EU/1/00/141/001/IS Myocet Iceland 13.10.2005 EU/1/00/141/001/NO Myocet Norway 28.9.2005 EU/1/00/142/004/NO-005/NO NovoMix Penfill Norway 13.10.2005 EU/1/00/142/004-005 NovoMix Liechtenstein 30.9.2005 EU/1/00/142/004-005/IS NovoMix 30 Penfill Iceland 21.10.2005 EU/1/00/142/009/NO-010/NO NovoMix Flexpen Norway 13.10.2005 EU/1/00/142/009-010/IS NovoMix 30 FlexPen Iceland 21.10.2005 EU/1/00/143/001/NO-006/NO Kogenate Bayer Norway 7.9.2005 EU/1/00/143/001-006 Kogenate Liechtenstein 30.9.2005 EU/1/00/143/001-006/IS Kogenate Bayer Iceland 7.10.2005 EU/1/00/144/001/NO-003/NO Helixate NexGen Norway 7.9.2005 EU/1/00/144/001-003 Helixate Liechtenstein 30.9.2005 EU/1/00/144/001-003/IS Helixate NexGen Iceland 7.10.2005 EU/1/00/145/001 Herceptin Liechtenstein 30.9.2005 EU/1/00/145/001/IS Herceptin Iceland 28.11.2005 EU/1/00/145/001/NO Herceptin Norway 23.9.2005 EU/1/00/146/001/NO-029/NO Keppra Norway 08.8.2005 EU/1/00/146/001-029 Keppra Liechtenstein 30.9.2005 EU/1/00/146/001-029/IS Keppra Iceland 12.9.2005 EU/1/00/148/001/NO-004/NO Agenerase Norway 12.12.2005 EU/1/00/148/001-004 Agenerase Liechtenstein 30.11.2005 EU/1/00/148/001-004/IS Agenerase Iceland 16.12.2005 EU/1/00/149/001 Panretin Liechtenstein 30.11.2005 EU/1/00/149/001/IS Panretin Iceland 16.12.2005 EU/1/00/149/001/NO Panretin Norway 9.12.2005 EU/1/00/150/001/NO-015/NO Actos Norway 2.11.2005 EU/1/00/150/001-015 Actos Liechtenstein 30.11.2005 EU/1/00/150/001-015/IS Actos Iceland 11.11.2005 EU/1/00/151/001/NO-013/NO Glustin Norway 2.11.2005 EU/1/00/151/001-013 Glustin Liechtenstein 30.11.2005 EU/1/00/151/001-013/IS Glustin Iceland 11.11.2005 EU/1/00/152/001-018 Infanrix hexa Liechtenstein 30.11.2005 EU/1/00/153/001-010 Infanrix penta Liechtenstein 30.11.2005 EU/1/00/153/001-010/IS Infanrix penta Iceland 16.12.2005 EU/1/00/153/001-010/NO Infanrix penta Norway 7.12.2005 EU/1/00152/001-018/NO Infanrix hexa Norway 7.12.2005 EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS Gonal-F Iceland 15.11.2005 EU/1/95/001/001/NO Gonal-F Norway 11.11.2005 EU/1/95/001/003/NO-006/NO Gonal-F Norway 11.11.2005 EU/1/95/001/009/NO Gonal-F Norway 11.11.2005 EU/1/95/001/012/NO Gonal-F Norway 11.11.2005 EU/1/95/001/021/NO-022/NO Gonal-F Norway 11.11.2005 EU/1/95/001/025/NO-028/NO Gonal-F Norway 11.11.2005 EU/1/95/001/031/NO-035/NO Gonal-F Norway 11.11.2005 EU/1/98/093/002 Forcaltonin Liechtenstein 31.7.2005 EU/1/99/127/001/NO-044/NO IntronA Norway 20.6.2005 EU/1/99/127/001-044 IntronA Liechtenstein 31.7.2005 EU/1/99/127/001-044/IS IntronA Iceland 27.6.2005 EU/1/99/128/001/NO-037/NO Viraferon Norway 20.6.2005 EU/1/99/128/001-037 Viraferon Liechtenstein 31.7.2005 EU/1/99/128/001-037/IS Viraferon Iceland 27.6.2005 EU/2/00/018/001 Incurin Liechtenstein 31.7.2005 EU/2/00/018/001/NO Incurin Norway 16.6.2005 EU/2/00/022//002b-03a Ibaflin Liechtenstein 30.9.2005 EU/2/00/022/001/NO-017/NO Ibaflin Norway 31.8.2005 EU/2/00/022/001-017/IS Ibaflin Iceland 15.07.2005 EU/2/00/022/001a Ibaflin Liechtenstein 30.9.2005 EU/2/00/022/001b-02a Ibaflin Liechtenstein 30.9.2005 EU/2/00/022/003b-04a Ibaflin Liechtenstein 30.9.2005 EU/2/00/022/004b Ibaflin Liechtenstein 30.9.2005 EU/2/00/022/005-017 Ibaflin Liechtenstein 30.9.2005 EU/2/00/024/001/IS Pruban Iceland 16.12.2005 EU/2/99/016/001/NO-006/NO Porcilis Pesti Norway 18.7.2005 EU/2/99/016/001-006 Porcilis Pesti Liechtenstein 31.7.2005 EU/2/99/016/001-006/IS Porcilis Pesti Iceland 13.7.2005 EU/2/99/017/001/NO-006/NO Ibraxion Norway 2.6.2005

ANNEX III 3. Extended Marketing Authorisations The following marketing authorisations have been extended in the EEA EFTA States during the period 1 June — 31 December 2005: EU-Number Product Country Date of extention EU/1/00/142/011/NO-013/NO NovoMix Penfill 50 Norway 1.11.2005 EU/1/00/142/001-013/IS NovoMix 50 Penfill suspension for injection Iceland 5.10.2005 EU/1/00/142/014/NO-016/NO NovoMix Flexpen 50 Norway 1.11.2005 EU/1/00/142/014-016/IS NovoMix 50 FlexPen suspension for injection Iceland 5.10.2005 EU/1/00/142/017/NO-019/NO NovoMix Penfill 70 Norway 1.11.2005 EU/1/00/142/017-019/IS NovoMix 70 Penfill suspension for injection Iceland 5.10.2005 EU/1/00/142/020/NO-022/NO NovoMix Flexpen 70 Norway 1.11.2005 EU/1/00/142/020-022/IS NovoMix 70 FlexPen suspension for injection Iceland 5.10.2005 EU/1/03/265/003/NO-004/NO Bonviva, film-coated tablets Norway 28.9.2005 EU/1/03/265/003-004/IS Bonviva, film-coated tablets Iceland 25.10.2005 EU/1/03/266/003/NO-004/NO Bondenza, film-coated tablets Norway 28.9.2005 EU/1/03/266/003-004/IS Bondenza, film-coated tablets Iceland 21.10.2005 EU/1/04/276/021/NO-023/NO Abilify, orodispersible tablet 5 mg Norway 18.7.2005 EU/1/04/276/021-023/IS Abilify, orodispersible tablet 5 mg Iceland 14.7.2005 EU/1/04/276/024/NO-026/NO Abilify, orodispersible tablet 10 mg Norway 18.7.2005 EU/1/04/276/024-026/IS Abilify, orodispersible tablet 10 mg Iceland 14.7.2005 EU/1/04/276/027/NO-029/NO Abilify, orodispersible tablet 15 mg Norway 18.7.2005 EU/1/04/276/027-029/IS Abilify, orodispersible tablet 15 mg Iceland 14.7.2005 EU/1/04/276/030/NO-032/NO Abilify, orodispersible tablet 30 mg Norway 18.7.2005 EU/1/04/276/030-032/IS Abilify, orodispersible tablet 30 mg Iceland 14.7.2005 EU/1/04/276/033/NO-035/NO Abilify 1mg/ml, oral solution Norway 9.11.2005 EU/1/04/276/033-035/IS Abilify 1 mg/ml, oral solution Iceland 1.12.2005 EU/1/96/026/002/IS Invirase, filmcoated tablet 500 mg Iceland 19.7.2005 EU/1/96/026/002/NO Invirase Norway 9.6.2005 EU/2/97/004/012/NO-013/NO Metacam, 0,5 mg/ml oral suspension for dogs Norway 5.9.2005 EU/2/97/004/012-013/IS Metacam, 0,5 mg/ml oral suspension for dogs Iceland 2.9.2005

ANNEX IV 4. Withdrawn Marketing Authorisations The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 June — 31 December 2005: EU-Number Product Country Date of withdrawal EU/1/00/158/001-034/IS Opulis Iceland 9.9.2005 EU/1/00/168/001/NO-006/NO Tenecteplase Norway 9.8.2005 EU/1/00/168/001-006 Tenecteplase Liechtenstein 30.9.2005 EU/1/02/208/001-008/IS Xapit Iceland 9.9.2005 EU/1/02/210/001/NO-008/NO Rayzon Norway 22.7.2005 EU/1/02/210/001-008 Rayzon Liechtenstein 31.7.2005 EU/1/02/210/001-008/IS Rayzon Iceland 5.7.2005 EU/1/02/242/001-024 Valdyn Liechtenstein 30.9.2005 EU/1/02/242/001-024/IS Valdyn, filmcoated tablets Iceland 5.07.2005 EU/1/02/244/001/NO-024/NO Valdyn Norway 22.7.2005 EU/1/02/244/001-024/IS Valdyn Liechtenstein 31.7.2005 EU/1/96/009/010/NO-017/NO Zerit Norway 30.9.2005 EU/1/96/009/010-017/IS Zerit prolonged-release capsules Iceland 29.11.2005 EU/1/96/023/001 Cea-Scan Liechtenstein 30.11.2005 EU/1/96/023/001/IS CEA-Scan Iceland 9.11.2005 EU/1/97/048/001-014/IS Infanrix HepB, suspension for injection Iceland 15.6.2005 EU/2/00/023/001-003 Pulsaflox Liechtenstein 30.11.2005