EN Official Journal of the European Union C 146/13

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2007

(2008/C 146/03)

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 2007, at their meeting on 14 March 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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 2007: EU Number Product Country Date of authorisation EU/1/06/361/001 Luminity Liechtenstein 31.12.2007 EU/1/07/387/001-008 Advagraf Liechtenstein 31.12.2007 EU/1/07/391/001/NO-004/NO Revlimid Norway 13.7.2007 EU/1/07/391/001-004/IS Revlimid Iceland 11.7.2007 EU/1/07/392/001 Circadin Liechtenstein 31.8.2007 EU/1/07/392/001/IS Circadin Iceland 8.8.2007 EU/1/07/392/001/NO Circadin Norway 15.8.2007 EU/1/07/393/001/IS Soliris Iceland 19.7.2007 EU/1/07/393/001/NO Soliris Norway 19.7.2007 EU/1/07/394/001/NO-006/NO Optaflu Norway 20.8.2007 EU/1/07/395/001/NO-064/NO Invega Norway 17.7.2007 EU/1/07/395/001-064 Invega Liechtenstein 31.8.2007 EU/1/07/395/001-064/IS Invega Iceland 20.7.2007 EU/1/07/396/001/NO-003/NO Pergoveris Norway 3.7.2007 EU/1/07/396/001-003 Pergoveris Liechtenstein 31.8.2007 EU/1/07/396/001-003/IS Pergoveris Iceland 20.7.2007 EU/1/07/397/001 Siklos Liechtenstein 31.8.2007 EU/1/07/397/001/IS Siklos Iceland 19.7.2007 EU/1/07/397/001/NO Siklos Norway 22.8.2007 EU/1/07/398/001/NO-014/NO Optimark Norway 20.8.2007 EU/1/07/398/001-014 OptiMark Liechtenstein 31.8.2007 EU/1/07/398/001-014/IS OptiMark Iceland 20.8.2007 EU/1/07/399/001/NO-006/NO Aerinaze Norway 22.8.2007 EU/1/07/399/001-006 Aerinaze Liechtenstein 31.8.2007 EU/1/07/399/001-006/IS Aerinaze Iceland 30.8.2007 EU/1/07/400/001/NO-016/NO Mircera Norway 3.9.2007 EU/1/07/400/001-016/IS Mircera Iceland 17.8.2007 EU/1/07/401/001/NO-006/NO Orlistat GSK Norway 20.8.2007 EU/1/07/401/001-006 Orlistat GSK Liechtenstein 31.8.2007 EU/1/07/401/001-006/IS Orlistat GSK Iceland 21.8.2007 EU/1/07/402/001 Increlex Liechtenstein 31.8.2007 EU/1/07/402/001/IS Increlex Iceland 31.8.2007 EU/1/07/403/001 Atriance Liechtenstein 31.10.2007 EU/1/07/403/001/IS Atriance Iceland 20.9.2007 EU/1/07/403/001/NO Atriance Norway 4.9.2007 EU/1/07/404/001/NO-005/NO Flebogammadif Norway 13.9.2007 EU/1/07/404/001-005 Flebogammadif Liechtenstein 31.10.2007 EU/1/07/404/001-005/IS Flebogammadif Iceland 13.9.2007 EU/1/07/405/001/NO-020/NO Rasilez Norway 14.9.2007 EU/1/07/405/001-020 Rasilez Liechtenstein 31.10.2007 EU/1/07/405/001-020/IS Rasilez Iceland 6.9.2007 EU/1/07/406/001/NO-020/NO Enviage Norway 14.9.2007 EU/1/07/406/001-020 Enviage Liechtenstein 31.10.2007 EU/1/07/406/001-020/IS Enviage Iceland 11.9.2007 EU/1/07/407/001/NO-020/NO Sprimeo Norway 14.9.2007 EU/1/07/407/001-020 Sprimeo Liechtenstein 31.10.2007 EU/1/07/407/001-020/IS Sprimeo Iceland 11.9.2007 EU/1/07/408/001/NO-020/NO Tekturna Norway 14.9.2007 EU/1/07/408/001-020 Tekturna Liechtenstein 31.10.2007 EU/1/07/408/001-020/IS Tekturna Iceland 6.9.2007 EU/1/07/409/001/NO-020/NO Riprazo Norway 14.9.2007 EU/1/07/409/001-020 Riprazo Liechtenstein 31.10.2007 EU/1/07/409/001-020/IS Riprazo Iceland 11.9.2007 EU/1/07/410/001/NO-016/NO Binocrit Norway 13.9.2007 EU/1/07/410/001-016 Binocrit Liechtenstein 31.10.2007 EU/1/07/410/001-016/IS Binocrit Iceland 18.9.2007 EU/1/07/411/001/NO-016/NO Epoetin alfa Hexal Norway 13.9.2007 EU/1/07/411/001-016 Epoetin alfa Hexal Liechtenstein 31.10.2007 EU/1/07/411/001-016/IS Epoetin alfa Hexal Iceland 19.9.2007 EU/1/07/412/001/NO-016/NO Abseamed Norway 12.9.2007 EU/1/07/412/001-016 Abseamed Liechtenstein 31.10.2007 EU/1/07/412/001-016/IS Abseamed Iceland 19.9.2007 EU/1/07/413/001/NO-003/NO Gliolan Norway 28.9.2007 EU/1/07/413/001-003 Gliolan Liechtenstein 31.10.2007 EU/1/07/413/001-003/IS Gliolan Iceland 21.9.2007 EU/1/07/414/001/NO-017/NO Galvus Norway 8.10.2007 EU/1/07/414/001-017 Galvus Liechtenstein 31.10.2007 EU/1/07/414/001-017/IS Galvus Iceland 18.10.2007 EU/1/07/415/001/NO-056/NO Zalasta Norway 16.10.2007 EU/1/07/415/001-056/IS Zalasta Iceland 26.10.2007 EU/1/07/415/001-056 Zalasta Liechtenstein 31.10.2007 EU/1/07/416/001 Ecalta Liechtenstein 31.10.2007 EU/1/07/416/001/IS Ecalta Iceland 13.10.2007 EU/1/07/416/001/NO Ecalta Norway 28.9.2007 EU/1/07/417/001/NO-002/NO Yondelis Norway 23.10.2007 EU/1/07/417/001-002 Yondelis Liechtenstein 31.10.2007 EU/1/07/417/001-002/IS Yondelis Iceland 15.10.2007 EU/1/07/418/001/NO-010/NO Celsentri Norway 25.9.2007 EU/1/07/418/001-010 Celsentri Liechtenstein 31.10.2007 EU/1/07/418/001-010/IS Celsentri Iceland 13.10.2007 EU/1/07/419/001/NO-009/NO Cervarix Norway 25.9.2007 EU/1/07/419/001-009 Cervarix Liechtenstein 31.10.2007 EU/1/07/419/001-009/IS Cervarix Iceland 12.10.2007 EU/1/07/420/001 Cyanokit Liechtenstein 31.12.2007 EU/1/07/420/001/IS Cyanokit Iceland 17.12.2007 EU/1/07/420/001/NO Cyanokit Norway 19.12.2007 EU/1/07/421/001/NO-009/NO Pioglitazon/metformin Takeda Norway 19.12.2007 EU/1/07/421/001-009 Pioglitazone/Metformin Hydrochloride Takeda Liechtenstein 31.12.2007 EU/1/07/422/001-004/IS Tasigna Iceland 14.12.2007 EU/1/07/424/001 Torisel Liechtenstein 31.12.2007 EU/1/07/424/001/IS Torisel Iceland 10.12.2007 EU/1/07/424/001/NO Torisel Norway 3.12.2007 EU/1/07/425/001/NO-018/NO Eucreas Norway 5.12.2007 EU/1/07/425/001-018 Eucreas Liechtenstein 31.12.2007 EU/1/07/425/001-018/IS Eucreas Iceland 6.12.2007 EU/1/07/426/001/NO-011/NO Olanzapine Neopharma Norway 19.12.2007 EU/1/07/426/001-011/IS Olanzapine Neopharma Iceland 7.12.2007 EU/1/07/426/001-011 Olanzapine Neopharma Liechtenstein 31.12.2007 EU/1/07/433/001 Nevanac Liechtenstein 31.12.2007 EU/1/07/433/001/NO Nevanac Norway 18.12.2007 EU/107/427/001-037 Olanzapine Teva Liechtenstein 31.12.2007 EU/2/06/067/001-002 Medicinal Oxygen Air Liquide Santé Liechtenstein 31.12.2007 EU/2/06/070/001-003/IS Meloxidyl Iceland 17.8.2007 EU/2/07/072/001/NO-002/NO Suprelorin Norway 24.10.2007 EU/2/07/072/001-002 Suprelorin Liechtenstein 31.8.2007 EU/2/07/072/001-002/IS Suprelorin Iceland 10.8.2007 EU/2/07/074/001/NO-006/NO Prilactone Norway 20.12.2007 EU/2/07/074/001-006/IS Prilactone Iceland 19.7.2007 EU/2/07/075/001/NO-004/NO Circovac Norway 20.12.2007 EU/2/07/075/001-004 Circovac Liechtenstein 31.8.2007 EU/2/07/075/001-004/IS Circovac Iceland 12.7.2007 EU/2/07/077/001-005 Meloxivet Liechtenstein 31.12.2007

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 2007: EU Number Product Country Date of authorisation EU/1/02/209/001/NO-008/NO Dynastat Norway 14.9.2007 EU/1/02/216/001/NO-002/NO Invanz Norway 4.7.2007 EU/1/02/218/001/NO-011/NO Axura Norway 16.7.2007 EU/1/02/218/001-011/IS Axura Iceland 11.7.2007 EU/1/02/219/001/NO-015/NO Ebixa Norway 11.7.2007 EU/1/02/219/001-015/IS Ebixa Iceland 6.7.2007 EU/1/02/220/001/NO-005/NO Tracleer Norway 13.8.2007 EU/1/02/221/001/NO-010/NO Pegasys Norway 18.7.2007 EU/1/02/221/001-010/IS Pegasys Iceland 13.7.2007 EU/1/02/221/001-010 Pegasys Liechtenstein 31.8.2007 EU/1/02/222/001/NO-002/NO Tamiflu Norway 31.7.2007 EU/1/02/222/001-002 Tamiflu Liechtenstein 31.8.2007 EU/1/02/222/001-004/IS Tamiflu Iceland 13.7.2007 EU/1/02/223/001/NO-003/NO Evra Norway 17.9.2007 EU/1/02/223/001-003 Evra Liechtenstein 31.10.2007 EU/1/02/223/001-003/IS Evra Iceland 1.10.2007 EU/1/02/224/001/NO-005/NO Ambirix Norway 25.9.2007 EU/1/02/224/001-005 Ambirix Liechtenstein 31.10.2007 EU/1/02/224/001-005/IS Ambirix Iceland 1.10.2007 EU/1/02/225/001/NO-002/NO Xigris Norway 27.8.2007 EU/1/02/225/001-002 Xigris Liechtenstein 31.8.2007 EU/1/02/225/001-002/IS Xigris Iceland 16.8.2007 EU/1/02/226/001 InductOs Liechtenstein 31.10.2007 EU/1/02/226/001/IS InductOs Iceland 17.9.2007 EU/1/02/226/001/NO InductOs Norway 10.9.2007 EU/1/02/227/001/NO-003/NO Neulasta Norway 27.8.2007 EU/1/02/227/001-003 Neulasta Liechtenstein 31.8.2007 EU/1/02/227/001-003/IS Neulasta Iceland 16.8.2007 EU/1/02/228/001-003/IS Neupopeg Iceland 15.8.2007 EU/1/02/228/001/NO-003/NO Neupopeg Norway 27.8.2007 EU/1/02/228/001-003 Neupopeg Liechtenstein 31.8.2007 EU/1/02/229/001/NO-037/NO Actraphane Norway 9.10.2007 EU/1/02/229/001-037 Actraphane Liechtenstein 31.10.2007 EU/1/02/229/001-037/IS Actraphane Iceland 15.10.2007 EU/1/02/230/001/NO-017/NO Actrapid Norway 9.10.2007 EU/1/02/230/001-017 Actrapid Liechtenstein 31.10.2007 EU/1/02/230/001-017/IS Actrapid Iceland 15.10.2007 EU/1/02/231/001/NO-037/NO Mixtard Norway 9.10.2007 EU/1/02/231/001-037 Mixtard Liechtenstein 31.10.2007 EU/1/02/231/001-037/IS Mixtard Iceland 16.10.2007 EU/1/02/232/001/NO-003/NO Velosulin Norway 9.10.2007 EU/1/02/232/001-003 Velosulin Liechtenstein 31.10.2007 EU/1/02/232/001-003/IS Velosulin Iceland 15.10.2007 EU/1/02/233/001/NO-017/NO Insulatard Norway 9.10.2007 EU/1/02/233/001-017 Insulatard Liechtenstein 31.10.2007 EU/1/02/233/001-017/IS Insulatard Iceland 16.10.2007 EU/1/02/234/001/NO-017/NO Protaphane Norway 9.10.2007 EU/1/02/234/001-017 Protaphane Liechtenstein 31.10.2007 EU/1/02/234/001-017/IS Protaphane Iceland 15.10.2007 EU/1/02/237/001/NO-008/NO Cialis Norway 15.10.2007 EU/1/02/237/001-008 Cialis Liechtenstein 31.10.2007 EU/1/02/237/001-008/IS Cialis Iceland 15.10.2007 EU/1/02/238/001 Zavesca Liechtenstein 31.10.2007 EU/1/02/238/001/IS Zavesca Iceland 1.10.2007 EU/1/02/238/001/NO Zavesca Norway 17.9.2007 EU/1/02/240/001/NO-004/NO Somavert Norway 26.9.2007 EU/1/02/240/001-004 Somavert Liechtenstein 31.10.2007 EU/1/02/240/001-004/IS Somavert Iceland 19.10.2007 EU/1/97/031/001/NO-003/NO, 019/NO-046/NO Neorecormon Norway 17.7.2007 EU/1/97/031/001-003, 019-046 NeoRecormon Liechtenstein 31.8.2007 EU/1/97/031/001-013, 019-024, 027-046/IS NeoRecormon Iceland 11.7.2007 EU/1/97/032/001/NO LeukoScan Norway 4.7.2007 EU/1/97/037/001/IS Vistide Iceland 6.7.2007 EU/1/97/037/001/NO Vistide Norway 13.9.2007 EU/1/97/039/001/NO-004/NO Cystagon Norway 31.7.2007 EU/1/97/039/001-004 Cystagon Liechtenstein 31.8.2007 EU/1/97/039/001-004/IS Cystagon Iceland 11.7.2007 EU/1/97/040/001/NO-002/NO Teslascan Norway 20.8.2007 EU/1/97/043/001/NO-003/NO Revasc Norway 16.7.2007 EU/1/97/043/001-003 Revasc Liechtenstein 31.8.2007 EU/1/97/043/001-003/IS Revasc Iceland 11.7.2007 EU/1/97/046/001/NO-039/NO Aprovel Norway 19.9.2007 EU/1/97/046/001-033 Aprovel Liechtenstein 31.10.2007 EU/1/97/046/001-039/IS Aprovel Iceland 18.9.2007 EU/1/97/047/001/NO-007/NO BeneFIX Norway 11.9.2007 EU/1/97/047/001-007 Benefix Liechtenstein 31.10.2007 EU/1/97/047/001-007/IS BeneFix Iceland 31.8.2007 EU/1/97/049/001/NO-039/NO Karvea Norway 20.9.2007 EU/1/97/049/001-033 Karvea Liechtenstein 31.10.2007 EU/1/97/049/001-039/IS Karvea Iceland 17.9.2007 EU/1/97/050/001/NO-006/NO, 009/NO-012/NO Sifrol Norway 16.10.2007 EU/1/97/050/001-006, 009-012 Sifrol Liechtenstein 31.10.2007 EU/1/97/050/001-006, 009-012/IS Sifrol Iceland 15.10.2007 EU/1/97/051/001/NO-006/NO, 009/NO-012/NO Mirapexin Norway 15.10.2007 EU/1/97/051/001-006, 009-012 Mirapexin Liechtenstein 31.10.2007 EU/1/97/051/001-006, 009-012/IS Mirapexin Iceland 15.10.2007 EU/1/97/053/001/NO-005/NO Cerezyme Norway 9.10.2007 EU/1/97/053/001-005 Cerezyme Liechtenstein 31.10.2007 EU/1/97/053/001-005/IS Cerezyme Iceland 15.10.2007 EU/1/97/057/001 Quadramet Liechtenstein 31.12.2007 EU/2/02/032/001/IS Vaxxitek HVT + IBD Iceland 10.7.2007 EU/2/02/033/001/IS Dexdomitor Iceland 17.8.2007 EU/2/02/034/001/IS Nobivac Bb cat Iceland 19.10.2007 EU/2/02/035/001-007 SevoFlo Liechtenstein 31.12.2007 EU/2/02/035/001-007/IS SevoFlo Iceland 6.12.2007 EU/2/033/001 Dexdomitor Liechtenstein 31.10.2007 EU/2/034/001 Nobivac Bb Liechtenstein 31.10.2007 EU/2/97/001-009/IS Quadrisol Iceland 10.12.2007 EU/2/97/004/001, EU/2/97/004/003-028 Metacam Liechtenstein 31.12.2007 EU/2/97/004/001/NO, 003/NO-030/NO Metacam Norway 17.12.2007 EU/2/97/005/001-009 Quadrisol Liechtenstein 31.12.2007 EU/2/98/010/004-014, 017-018, 021-024/IS Econor Iceland 8.11.2007

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 2007: EU Number Product Country Date of extention EU/1/00/151/023-024 Glustin Liechtenstein 31.10.2007 EU/1/01/197/003/NO-005/NO Foscan Norway 8.11.2007 EU/1/01/197/003-005 Foscan Liechtenstein 31.10.2007 EU/1/01/197/003-005/IS Foscan Iceland 12.11.2007 EU/1/02/222/003/NO-004/NO Tamiflu Norway 27.9.2007 EU/1/02/222/003-004 Tamiflu Liechtenstein 31.10.2007 EU/1/02/222/003-004/IS Tamiflu Iceland 15.10.2007 EU/1/02/237/006/NO-008/NO Cialis Norway 3.7.2007 EU/1/02/237/006-008 Cialis Liechtenstein 31.8.2007 EU/1/03/254/002 Busilvex Liechtenstein 31.12.2007 EU/1/03/260/016-018 Stalevo Liechtenstein 31.10.2007 EU/1/04/290/002 Alimta Liechtenstein 31.12.2007 EU/1/04/290/002/IS Alimta Iceland 15.11.2007 EU/1/04/296/009 Cymbalta Liechtenstein 31.10.2007 EU/1/05/310/006/NO-009/NO Fosavance Norway 8.11.2007 EU/1/05/310/006-009 Fosavance Liechtenstein 31.12.2007 EU/1/05/310/006-009/IS Fosavance Iceland 19.10.2007 EU/1/05/325/002 Macugen Liechtenstein 31.12.2007 EU/1/06/332/004/NO-006/NO Omnitrope Norway 10.9.2007 EU/1/06/332/007/NO-009/NO Omnitrope Norway 8.11.2007 EU/1/06/332/007-009 Omnitrope Liechtenstein 31.10.2007 EU/1/06/332/007-009/IS Omnitrope Iceland 17.10.2007 EU/1/06/344/010-011 Acomplia Liechtenstein 31.10.2007 EU/1/06/345/010-011 Zimulti Liechtenstein 31.10.2007 EU/1/06/347/004-006 Sutent Liechtenstein 31.12.2007 EU/1/06/361/002 Luminity Liechtenstein 31.12.2007 EU/1/06/364/006/NO-009/NO Adrovance Norway 14.11.2007 EU/1/06/364/006-009 Adrovance Liechtenstein 31.10.2007 EU/1/06/364/006-009/IS Adrovance Iceland 19.10.2007 EU/1/06/366/005-016 Tandemact Liechtenstein 31.12.2007 EU/1/95/003/005-006 Betaferon Liechtenstein 31.10.2007 EU/1/96/022/023-034 Zyprexa Liechtenstein 31.8.2007 EU/1/97/033/004 Avonex Liechtenstein 31.8.2007 EU/1/97/046/034-039 Aprovel Liechtenstein 31.10.2007 EU/1/97/047/004/NO-007/NO BeneFIX Norway 4.9.2007 EU/1/97/047/004-007 BenFix Liechtenstein 31.8.2007 EU/1/97/047/007/IS Benefix Iceland 31.8.2007 EU/1/97/049/034-039 Karvea Liechtenstein 31.10.2007 EU/1/98/066/019/NO-026/NO Exelon Norway 10.10.2007 EU/1/98/066/019-026 Exelon Liechtenstein 31.10.2007 EU/1/98/066/019-026/IS Exelon Iceland 17.10.2007 EU/1/98/069/007a, 007b Plavix Liechtenstein 31.8.2007 EU/1/98/070/007a, 007b Iscover Liechtenstein 31.8.2007 EU/1/98/085/029-034 Karvezide Liechtenstein 31.10.2007 EU/1/98/086/029-034 CoAprovel Liechtenstein 31.10.2007 EU/1/98/092/019/NO-026/NO Prometax Norway 10.10.2007 EU/1/98/092/019-026 Prometax Liechtenstein 31.10.2007 EU/1/98/092/019-026/IS Prometax Iceland 18.10.2007 EU/1/99/108/002-003 Ferriprox Liechtenstein 31.12.2007 EU/1/99/108/002/NO-003/NO Ferriprox Norway 5.12.2007 EU/1/99/108/002-003/IS Ferriprox Iceland 10.12.2007 EU/2/039/019-030 Advocate Liechtenstein 31.8.2007 EU/2/97/004/029-030 Metacam Liechtenstein 31.12.2007

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 2007: EU Number Product Country Date of withdrawal EU/1/01/92/001-005 Levviax Liechtenstein 31.12.2007 EU/1/03/257/001/NO-010/NO Trudexa Norway 29.8.2007 EU/1/03/257/001-010 Trudexa Liechtenstein 31.8.2007 EU/1/03/257/001-010/IS Trudexa Iceland 9.8.2007