EN Official Journal of the European Union C 233/28

List of marketing authorisations granted by the EEA EFTA States for the second half of 2003

(2006/C 233/09)

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 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 July — 31 December 2003:

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Annex IV List of withdrawn marketing authorisations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 1. New Marketing Authorisations: The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July — 31 December 2003: EU-Number Product Country Date of authorisation EU/1/00/141/001/IS Myocet conc. F. inf. Liposomes Iceland 31.7.2003 EU/1/00/150/011-015 Actos Liechtenstein 30.9.2003 EU/1/00/151/009-013 Glustin Liechtenstein 30.9.2003 EU/1/00/165/007 Ovitrelle Liechtenstein 30.11.2003 EU/1/02/206/005-008 Arixtra Liechtenstein 30.11.2003 EU/1/02/207/005-008 Quixidar Liechtenstein 30.11.2003 EU/1/02/219/010-013 Ebixa Liechtenstein 30.9.2003 EU/1/02/229/036-037 Actraphane Liechtenstein 30.9.2003 EU/1/02/230/016-017 Actrapid Liechtenstein 30.9.2003 EU/1/02/231/036-037 Mixtard Liechtenstein 30.9.2003 EU/1/02/232/003 Velosulin Liechtenstein 30.9.2003 EU/1/02/233/016-017 Insulatard Liechtenstein 30.9.2003 EU/1/02/234/016-017 Protaphane Liechtenstein 30.9.2003 EU/1/02/240/004 Somavert Liechtenstein 30.9.2003 EU/1/02/242/001-010/IS Valdyn tablets 10 mg Iceland 1.7.2003 EU/1/02/242/011-020/IS Valdyn tablets 20 mg Iceland 1.7.2003 EU/1/02/242/021-024/IS Valdyn tablets 40 mg Iceland 1.7.2003 EU/1/02/244/001-010/IS Kudeq tablets 10 mg Iceland 1.7.2003 EU/1/02/244/011-020/IS Kudeq tablets 20 mg Iceland 1.7.2003 EU/1/02/244/021-024/IS Kudeq tablets 40 mg Iceland 1.7.2003 EU/1/03/247/001-002 Forsteo Liechtenstein 31.7.2003 EU/1/03/247/001-002/IS Forsteo sol for inj. in prefilled pen Iceland 8.7.2003 EU/1/03/252/001-003 Fuzeon Liechtenstein 31.7.2003 EU/1/03/253/001-003 Aldurazyme Liechtenstein 31.7.2003 EU/1/03/253/001-003/IS Aldurazyme conc. for sol. f. inf. 100 U/ml Iceland 21.7.2003 EU/1/03/254/001 Busilvex Liechtenstein 30.9.2003 EU/1/03/254/001/IS Busilvex 6 mg/ml conc.f. sol. f.inf. Iceland 22.7.2003 EU/1/03/254/001/NO Busilvex Norway 17.7.2003 EU/1/03/255/001/NO-003/NO Ventavis Norway 30.10.2003 EU/1/03/255/001-003/IS Ventavis Nebul. sol.- Inhal. 10 microg/ml Iceland 15.10.2003 EU/1/03/256/001/NO-006/NO Humira Norway 11.9.2003 EU/1/03/256/001-006 Humira Liechtenstein 30.9.2003 EU/1/03/256/001-006/IS Humira solution for injection Iceland 25.9.2003 EU/1/03/257/001/NO-006/NO Trudexa Norway 17.9.2003 EU/1/03/257/001-006 Trudexa Liechtenstein 30.9.2003 EU/1/03/257/001-006/IS Trudexa solution for injection Iceland 29.9.2003 EU/1/03/258/001/NO-006/NO Avandamet Norway 18.11.2003 EU/1/03/258/001-003/IS Avandamet tabl. 1mg/500 mg Iceland 19.11.2003 EU/1/03/258/001-006 Avandamet Liechtenstein 30.11.2003 EU/1/03/258/004-006/IS Avandamet tabl. 2mg/500mg Iceland 19.11.2003 EU/1/03/259/001/NO-006/NO Onsenal Norway 5.11.2003 EU/1/03/259/001-004/IS Onsenal Hard capsules 200 mg Iceland 16.12.2003 EU/1/03/259/001-006 Onsenal Liechtenstein 30.11.2003 EU/1/03/259/005-006/IS Onsenal Hard capsules 400 mg Iceland 16.12.2003 EU/1/03/260/001/NO-012/NO Stalevo Norway 5.11.2003 EU/1/03/260/001-004/IS Stalevo tabl. 50/12.5/200 mg Iceland 31.10.2003 EU/1/03/260/001-012 Stalevo Liechtenstein 30.11.2003 EU/1/03/260/005-008/IS Stalevo tab. 100/25/200 mg Iceland 31.10.2003 EU/1/03/260/009-012/IS Stalevo tabl. 150/37.5/200 mg Iceland 31.10.2003 EU/1/03/261/001/NO-003/NO Emtriva Norway 5.11.2003 EU/1/03/261/001-002/IS Emtriva hard caps. 200 mg Iceland 8.11.2003 EU/1/03/261/001-003 Emtriva Liechtenstein 30.11.2003 EU/1/03/261/003/IS Emtriva oral sol. 10mg/ml Iceland 8.11.2003 EU/1/03/262/001/NO-006/NO Emend Norway 15.12.2003 EU/1/03/262/001-003/IS Emend hard caps. 80 mg Iceland 11.12.2003 EU/1/03/262/004-006/IS Emend hard caps. 80 mg and 125 mg (comb.) Iceland 11.12.2003 EU/1/03/262/005/IS Emend hard caps. 125 mg Iceland 11.12.2003 EU/1/96/012/001-013 Bondronat Liechtenstein 30.11.2003 EU/1/96/015/004-005 Epivir Liechtenstein 30.9.2003 EU/1/97/033/003 Avonex Liechtenstein 31.7.2003 EU/1/98/064/001/NO Pylobactell Norway 1.7.2003 EU/1/98/076/001/NO-002/NO, 004/NO-009/NO NovoNorm Norway 15.8.2003 EU/1/98/076/011/NO-016/NO, 018/NO-021/NO NovoNorm Norway 15.8.2003 EU/1/99/119/012-014 NovoRapid Liechtenstein 31.7.2003 EU/2/00/025/001/NO-006/NO Bayovac CSF E2 Norway 8.9.2003 EU/2/00/027/001/NO-003/NO Pirsue Norway 2.9.2003 EU/2/01/030/001/IS Virbagen Omega powd. & solv. for susp. f. inj. 5 MU Iceland 10.12.2003 EU/2/01/030/002/IS Virbagen Omega powd. & solv. for susp. f. inj. 10 MU Iceland 10.12.2003 EU/2/02/035/001/NO-006/NO SevoFlo Norway 2.9.2003 EU/2/02/035/001-006/IS SevoFlo Inhalation vapour, liquid for dogs Iceland 1.8.2003 EU/2/03/039/001-004 & 013-014/IS Advocate spot on sol. for cats Iceland 25.9.2003 EU/2/03/039/005-012 & 015-018/IS Advocate spot on sol for dogs Iceland 25.9.2003 EU/2/03/039/013-018 Advocate Liechtenstein 31.7.2003 EU/2/03/040/001 Gonazon Liechtenstein 30.9.2003 EU/2/03/040/001/IS Gonazon solution injection 1.600 microg/ml Iceland 30.10.2003 EU/2/03/040/001/NO Gonazon Norway 18.8.2003 EU/2/03/041/001/NO-005/NO Draxxin Norway 10.12.2003 EU/2/03/041/001-005 Draxxin Liechtenstein 30.11.2003 EU/2/03/041/001-005/IS Draxxin sol for injection, cattle and pigs Iceland 12.12.2003 EU/2/97/003/001-018 Dicural Liechtenstein 30.9.2003 EU/2/97/004/009 Metacam Liechtenstein 30.11.2003

ANNEX II 2. Renewed Marketing Authorisations The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July — 31 December 2003: EU-Number Product Country Date of authorisation EU/1/00/162/001-006/IS Prandin 0.5 mg tablets Iceland 25.9.2003 EU/1/00/162/001-018 Prandin Liechtenstein 30.9.2003 EU/1/00/162/001-018/NO Prandin Norway 15.8.2003 EU/1/00/162/007-012/IS Prandin 1 mg tablets Iceland 25.9.2003 EU/1/00/162/013-018/IS Prandin 2 mg tablets Iceland 25.9.2003 EU/1/97/047/001/NO-003/NO Benefix Norway 30.12.2003 EU/1/97/048/001/NO-014/NO InfanrixHep B Norway 20.11.2003 EU/1/97/051/001/NO-006/NO, 009/NO-012/NO Mirapexin Norway 1.9.2003 EU/1/98/058/001-002 Combivir Liechtenstein 31.7.2003 EU/1/98/058/001-002/IS Combivir 150/300 mg film coated tablets Iceland 16.9.2003 EU/1/98/058/001-002/NO Combivir Norway 7.7.2003 EU/1/98/063/001-003/IS Rebif 22 microg/0.5 ml. solution for injection Iceland 18.9.2003 EU/1/98/063/001-006 Rebif Liechtenstein 31.7.2003 EU/1/98/063/001-006/NO Rebif Norway 19.8.2003 EU/1/98/063/004-006/IS Rebif 44 microg/0.5 ml. solution for injection Iceland 18.9.2003 EU/1/98/064/001 Pylobactell Liechtenstein 31.7.2003 EU/1/98/064/001/IS Pylobactell 100 mg soluble tablet Iceland 21.10.2003 EU/1/98/066/001-003/IS Exelon capsules hard, 1.5 mg Iceland 26.8.2003 EU/1/98/066/001-013 Exelon Liechtenstein 31.7.2003 EU/1/98/066/001-013/NO Exelon Norway 15.7.2003 EU/1/98/066/004-006/IS Exelon capsules hard, 3 mg Iceland 26.8.2003 EU/1/98/066/007-009/IS Exelon capsules hard, 4.5 mg Iceland 26.8.2003 EU/1/98/066/010-012/IS Exelon capsules hard, 6 mg Iceland 26.8.2003 EU/1/98/066/013/IS Exelon oral solution 2 mg/ml Iceland 26.8.2003 EU/1/98/067/001/IS MabThera Concentrate for solution for infusion 100 mg Iceland 13.10.2003 EU/1/98/067/001-002 Mabthera Liechtenstein 30.9.2003 EU/1/98/067/001-002/NO Mabthera Norway 6.8.2003 EU/1/98/067/002/IS MabThera Concentrate for solution for infusion 500 mg Iceland 13.10.2003 EU/1/98/069/001-004/IS Plavix tablets 75 mg Iceland 20.11.2003 EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b Plavix Liechtenstein 30.11.2003 EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b/NO Plavix Norway 7.11.2003 EU/1/98/070/001-004/IS Iscover tablets 75 mg Iceland 20.11.2003 EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b Iscover Liechtenstein 30.11.2003 EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b/NO Iscover Norway 7.11.2003 EU/1/98/071/001-006 Xenical Liechtenstein 30.11.2003 EU/1/98/071/001-006/IS Xenical hard capsules 120 mg Iceland 1.12.2003 EU/1/98/071/001-006/NO Xenical Norway 24.10.2003 EU/1/98/073/001-004 Evista Liechtenstein 30.9.2003 EU/1/98/073/001-004/IS Evista film coated tablets 60 mg Iceland 18.9.2003 EU/1/98/073/001-004/NO Evista Norway 1.8.2003 EU/1/98/074/001-004 Optruma Liechtenstein 30.9.2003 EU/1/98/074/001-004/IS Optruma film coated tablets 60 mg Iceland 18.9.2003 EU/1/98/074/001-004/NO Optruma Norway 1.8.2003 EU/1/98/075/001-002 Fortovase Liechtenstein 30.9.2003 EU/1/98/075/001-002/IS Fortovase soft capsule 200 mg Iceland 19.11.2003 EU/1/98/075/001-002/NO Fortovase Norway 8.10.2003 EU/1/98/076/001-002, 004-007/IS NovoNorm 0.5 mg tablets Iceland 25.9.2003 EU/1/98/076/001-002, 004-009 NovoNorm Liechtenstein 30.9.2003 EU/1/98/076/008-009, 011-014/IS NovoNorm 1 mg tablets Iceland 25.9.2003 EU/1/98/076/011-016, 018-021 NovoNorm Liechtenstein 30.9.2003 EU/1/98/076/015-016, 018-021/IS NovoNorm 2 mg tablets Iceland 25.9.2003 EU/1/98/077/001-012 Viagra Liechtenstein 30.11.2003 EU/1/98/077/001-012/NO Viagra Norway 11.12.2003 EU/1/98/080/001 Aldara Liechtenstein 30.11.2003 EU/1/98/080/001/IS Aldara cream 5% Iceland 3.12.2003 EU/1/98/080/001/NO Aldara Norway 14.11.2003 EU/1/98/081/001-004 Comtan Liechtenstein 30.11.2003 EU/1/98/081/001-004/IS Comtan filmcoated tablets Iceland 16.12.2003 EU/1/98/081/001-004/NO Comtan Norway 3.11.2003 EU/1/98/082/001-004 Comtess Liechtenstein 30.11.2003 EU/1/98/082/001-004/IS Comtess filmcoated tablets Iceland 27.11.2003 EU/1/98/082/001-004/NO Comtess Norway 14.11.2003 EU/1/98/084/001-002 Simulect Liechtenstein 30.11.2003 EU/1/98/084/001-002/NO Simulect Norway 18.11.2003 EU/1/98/085/001/NO-010/NO Karvezide Norway 18.12.2003 EU/1/98/086/001/NO-010/NO CoAprovel Norway 19.12.2003 EU/1/98/092/001-003/IS Prometax capsules hard 1.5 mg Iceland 29.8.2003 EU/1/98/092/001-013 Prometax Liechtenstein 31.7.2003 EU/1/98/092/001-013/NO Prometax Norway 15.7.2003 EU/1/98/092/004-006/IS Prometax capsules hard, 3 mg Iceland 29.8.2003 EU/1/98/092/007-009/IS Prometax capsules hard, 4.5 mg Iceland 29.8.2003 EU/1/98/092/010-012/IS Prometax capsules hard, 6 mg Iceland 29.8.2003 EU/1/98/092/013/IS Prometax oral solution 2mg/ml Iceland 29.8.2003 EU/2/96/002/001-003/IS Fevaxyn Pentofelsol. for inject. Iceland 15.10.2003 EU/2/97/003/001-003/IS Dicural 100 mg/ml oral solution Iceland 12.10.2003 EU/2/97/003/001-018/NO Dicural Norway 21.8.2003 EU/2/97/003/004-015/IS Dicural 15 mg, 50 mg, 100 mg, 150 mg film coated tablets Iceland 12.10.2003 EU/2/97/003/016-018/IS Dicural 50 mg/ml solution for inject. Iceland 12.10.2003 EU/2/97/004/001/IS Metacam 5 mg/ml solution for injection for cattle Iceland 8.7.2003 EU/2/97/004/003-005/IS Metacam 1.5 mg/ml oral suspension for dogs Iceland 8.7.2003 EU/2/97/004/006/IS Metacam 5 mg/ml solution for injection for dogs and cats Iceland 8.7.2003 EU/2/97/004/007-008/IS Metacam 20 mg/ml solution for injection for cattle Iceland 8.7.2003 EU/2/97/005/001, 005/IS Quadrisol oral gel for horses 100 mg/ml Iceland 27.10.2003 EU/2/97/005/002-003, 006-007/IS Quadrisol oral gel for dogs 5 mg/ml Iceland 27.10.2003 EU/2/97/005/004/IS Quadrisol sol. for injection Iceland 27.10.2003 EU/2/97/005/008-009/IS Quadrisol oral gel for dogs 1 mg/ml Iceland 27.10.2003 EU/2/98/006/001-010 Nobilis IB 4-91 Liechtenstein 30.9.2003 EU/2/98/006/001-010/IS Nobilis IB 4-91 sol. for injection Iceland 21.10.2003 EU/2/98/006/001-010/NO Nobilis IB 4-91 Norway 8.8.2003 EU/2/98/007/00/NO-003/NO Clomicalm Norway 1.9.2003 EU/2/98/007/001-003/IS Clomicalm tablets 5 mg, 20 mg, 80 mg Iceland 27.10.2003 EU/2/98/008/001-004/IS Neocolipor suspension for injection Iceland 22.10.2003

ANNEX III 3. Extended Marketing Authorisations The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July — 31 December 2003: EU-Number Product Country Date of extention EU/1/00/146/027/IS Keppra oral solution Iceland 19.8.2003 EU/1/00/150/011/NO-015/NO Actos Norway 25.9.2003 EU/1/00/150/011-015/IS Actos tablets 45 mg Iceland 27.11.2003 EU/1/00/165/007/IS Ovitrelle, sol. for inj. 250 microg/0.5 ml Iceland 16.12.2003 EU/1/00/165/007/NO Ovitrelle Norway 7.11.2003 EU/1/02/206/005/NO-008/NO Arixtra Norway 21.11.2003 EU/1/02/206/005-008/IS Arixtra solution for injection, 1.5 mg/0.3 ml. Iceland 4.12.2003 EU/1/02/207/00/NO-008/NO Quixidar Norway 21.11.2003 EU/1/02/207/005-009/IS Quixidar solution for injection, 1.5 mg/0.3 ml Iceland 4.12.2003 EU/1/96/009/010-017/IS Zerit caps. prolonged release Iceland 9.10.2003 EU/1/96/012/009/NO-013/NO Bondronat Norway 5.11.2003 EU/1/96/015/003/NO, EU/1/96/015/004/NO-005/NO Epivir Norway 29.7.2003 EU/1/97/033/003/IS Avonex sol. for injection 30 microg/0.5 ml Iceland 7.11.2003 EU/1/97/033/003/NO Avonex Norway 4.7.2003 EU/2/97/004/009/IS Metacam oral suspention for horses Iceland 29.10.2003 EU/2/97/004/009/NO Metacam Norway 24.10.2003