EN Official Journal of the European Union C 233/45

List of marketing authorisations granted by the EEA EFTA States for the second half of 2004

(2006/C 233/11)

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 2004:

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Annex IV List of withdrawn marketing authorisations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 2004: EU-Number Product Country Date of authorisation EU/1/00/134/022-029 Lantus Liechtenstein 30.9.2004 EU/1/00/138/001/NO-012/NO Venvia Norway 30.7.2004 EU/1/00/139/001/NO-012/NO Nyracta Norway 30.7.2004 EU/1/00/143/004-006 Kogenate Bayer Liechtenstein 30.9.2004 EU/1/01/178/001/NO Targretin Norway 13.7.2004 EU/1/01/184/033-044 Nespo Liechtenstein 30.11.2004 EU/1/01/185/033-044 Aranesp Liechtenstein 30.11.2004 EU/1/01/189/004-006 Replagal Liechtenstein 30.9.2004 EU/1/01/191/005 Ketek Liechtenstein 30.11.2004 EU/1/01/192/005 Levviax Liechtenstein 30.11.2004 EU/1/01/193/002 MabCampath Liechtenstein 30.11.2004 EU/1/02/206/009-017 Arixtra Liechtenstein 30.11.2004 EU/1/02/207/009-017 Quixidar Liechtenstein 30.11.2004 EU/1/02/221/009-010 Pegasys Liechtenstein 30.11.2004 EU/1/03/258/007-012 Avandamet Liechtenstein 30.9.2004 EU/1/03/270/001-002 Oxybutynin Liechtenstein 31.7.2004 EU/1/03/270/001-002/IS Oxybutynin Nicobrand transderm. patches, 3,9 mg/24hours Iceland 28.7.2004 EU/1/04/276/001-005/IS Abilify, tablets, 5 mg Iceland 1.7.2004 EU/1/04/276/001-020 Abilify Liechtenstein 31.7.2004 EU/1/04/276/006-010/IS Abilify, tablets,10 mg Iceland 1.7.2004 EU/1/04/276/011-015/IS Abilify, tablets, 15 mg Iceland 1.7.2004 EU/1/04/276/016-020/IS Abilify, tablets, 30 mg Iceland 1.7.2004 EU/1/04/277/001/IS TachoSil, medicated sponge, 5,5 mg + 2,0 IU Iceland 8.7.2004 EU/1/04/277/001/NO-004/NO TachoSil Norway 5.7.2004 EU/1/04/277/001-004 TachoSil Liechtenstein 31.7.2004 EU/1/04/278/001-009 Levemir Liechtenstein 31.7.2004 EU/1/04/279/001/NO-025/NO Lyrica Norway 4.8.2004 EU/1/04/279/001-005/IS LYRICA, capsule, hard, 25 mg Iceland 26.8.2004 EU/1/04/279/001-025 Lyrica Liechtenstein 30.9.2004 EU/1/04/279/006-010/IS LYRICA, capsule, hard, 50 mg Iceland 26.8.2004 EU/1/04/279/011-013/IS LYRICA, capsule, hard, 75 mg Iceland 26.8.2004 EU/1/04/279/014-016/IS LYRICA, capsule, hard, 150 mg Iceland 26.8.2004 EU/1/04/279/017-019/IS LYRICA, capsule, hard, 300 mg Iceland 26.8.2004 EU/1/04/279/020-022/IS LYRICA, capsule, hard, 100 mg Iceland 26.8.2004 EU/1/04/279/023-025/IS LYRICA, capsule, hard, 200 mg Iceland 26.8.2004 EU/1/04/280/001/IS Yentreve, gastro-resistant capsule, hard, 20 mg Iceland 9.9.2004 EU/1/04/280/001/NO-006/NO Yentreve Norway 26.8.2004 EU/1/04/280/001-006 Yentreve Liechtenstein 30.9.2004 EU/1/04/280/002-006/IS Yentreve, gastro-resistant capsule, hard, 40 mg Iceland 9.9.2004 EU/1/04/281/001 Erbitux Liechtenstein 31.7.2004 EU/1/04/281/001/IS Erbitux, solution for infusion, 2 mg/ml Iceland 26.7.2004 EU/1/04/281/001/NO Erbitux Norway 9.7.2004 EU/1/04/282/001/NO-002/NO Telzir Norway 19.7.2004 EU/1/04/282/001-002 Telzir Liechtenstein 30.9.2004 EU/1/04/282/001-002/IS Telzir tablets and oral susp. Iceland 10.8.2004 EU/1/04/283/001/IS Ariclaim, gastro-resistant capsule, hard, 20 mg Iceland 11.9.2004 EU/1/04/283/001/NO-006/NO Ariclaim Norway 27.8.2004 EU/1/04/283/001-006 Ariclaim Liechtenstein 30.9.2004 EU/1/04/283/002-006/IS Ariclaim, gastro-resistant capsule, hard, 40 mg Iceland 11.9.2004 EU/1/04/284/001 Pedea Liechtenstein 30.9.2004 EU/1/04/284/001/IS Pedea, solution for injection, 5mg/ml Iceland 12.8.2004 EU/1/04/284/001/NO Pedea Norway 18.8.2004 EU/1/04/285/001/NO-020/NO Apidra Norway 25.10.2004 EU/1/04/285/001-004/IS Apidra, solution for injection,vial, 100 units/ml Iceland 27.10.2004 EU/1/04/285/001-020 Apidra Liechtenstein 30.11.2004 EU/1/04/285/005/012/IS Apidra, solution for injection,cartridge, 100 units/ml Iceland 27.10.2004 EU/1/04/285/013-020/IS Apidra, solution for injection, pre-filled pen, 100 units/ml Iceland 27.10.2004 EU/1/04/286/001/IS Wilzin, capsule, hard, 25 mg Iceland 11.11.2004 EU/1/04/286/001/NO-002/NO Wilzin Norway 12.11.2004 EU/1/04/286/001-002 Wilzin Liechtenstein 30.11.2004 EU/1/04/286/002/IS Wilzin, capsule, hard, 50 mg Iceland 11.11.2004 EU/1/04/287/001/NO-006/NO Osseor Norway 18.10.2004 EU/1/04/287/001-006 Osseor Liechtenstein 30.11.2004 EU/1/04/287/001-006/IS Osseor, powder for oral suspension, 2g Iceland 27.10.2004 EU/1/04/288/001/NO-006/NO Protelos Norway 18.10.2004 EU/1/04/288/001-006 Protelos Liechtenstein 30.11.2004 EU/1/04/288/001-006/IS Protelos, powder for oral suspension, 2g Iceland 20.10.2004 EU/1/04/289/001 Angiox Liechtenstein 30.9.2004 EU/1/04/289/001/NO Angiox Norway 8.10.2004 EU/1/04/290/001 Alimta Liechtenstein 30.9.2004 EU/1/04/290/001/IS Alimta, concentrate for solution for infusion, 500 mg Iceland 19.10.2004 EU/1/04/290/001/NO Alimta, concentrate for solution for infusion, 500 mg Norway 19.10.2004 EU/1/04/291/001/NO-002/NO Raptiva Norway 30.9.2004 EU/1/04/291/001-001/IS Raptiva 100 mg/ml Powder and solvent for solution for injection Iceland 18.10.2004 EU/1/04/291/001-002 Raptiva Liechtenstein 30.9.2004 EU/1/04/292/001/NO-012/NO Mimpara Norway 11.11.2004 EU/1/04/292/001-004/IS Mimpara, film-coated tablet, 30 mg Iceland 19.11.2004 EU/1/04/292/001-012 Mimpara Liechtenstein 30.11.2004 EU/1/04/292/005-008/IS Mimpara, film-coated tablet, 60 mg Iceland 19.11.2004 EU/1/04/292/009-012/IS Mimpara, film-coated tablet, 90 mg Iceland 19.11.2004 EU/1/04/293/001/NO-012/NO Parareg Norway 11.11.2004 EU/1/04/293/001-004/IS Parareg, film-coated tablet, 30 mg Iceland 18.11.2004 EU/1/04/293/001-012 Parareg Liechtenstein 30.11.2004 EU/1/04/293/005-008/IS Parareg, film-coated tablet, 60 mg Iceland 18.11.2004 EU/1/04/293/009-012/IS Parareg, film-coated tablet, 90 mg Iceland 18.11.2004 EU/1/04/294/001/NO-012/NO Emselex Norway 16.11.2004 EU/1/04/294/001-006/IS Emselex 7,5 mg prolonged release tablets Iceland 24.11.2004 EU/1/04/294/001-012 Emselex Liechtenstein 30.11.2004 EU/1/04/294/007-012/IS Emselex 15 mg prolonged release tablets Iceland 24.11.2004 EU/1/04/295/001 Xagrid Liechtenstein 30.11.2004 EU/1/04/295/001/IS Xagrid, Capsules, hard, 0,5 mg Iceland 29.12.2004 EU/1/04/295/001/NO Xagrid Norway 15.12.2004 EU/1/96/008/040-041 Puregon Liechtenstein 30.9.2004 EU/1/96/013/001-004 Destara Liechtenstein 31.7.2004 EU/1/96/022/019-022 Zyprexa Liechtenstein 30.11.2004 EU/1/97/044/001-006 Tasmar Liechtenstein 30.11.2004 EU/1/99/104/001/NO Procomvax Norway 17.9.2004 EU/2/04/043/001/NO Equilis StrepE Norway 13.9.2004 EU/2/04/044/001/IS Aivlozin 42,5 mg/g premix for medicated feeding stuff for pigs Iceland 22.9.2004 EU/2/04/044/001/NO Aivlosin Norway 8.10.2004 EU/2/04/045/001/NO-004/NO Previcox Norway 13.10.2004 EU/2/04/045/001-002/IS Previcox, chewable tablet, 57 mg Iceland 4.10.2004 EU/2/04/045/001-004 Previcox Liechtenstein 30.9.2004 EU/2/04/045/003-004/IS Previcox, chewable tablet, 227 mg Iceland 4.10.2004 EU/2/04/046/001/NO-003/NO Nobivac Piro Norway 2.10.2004 EU/2/04/046/001-003 Nobivac Piro-606 Liechtenstein 30.9.2004 EU/2/96/001/009-010 Porcilis Porcoli Liechtenstein 30.9.2004

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 2004: EU-Number Product Country Date of renewal EU/1/99/119/009/IS-011/IS NovoRapid FlexPen, solution for injection, 100 units/ml Iceland 11.11.2004 EU/1/99/097/001 Beromun Liechtenstein 31.7.2004 EU/1/99/097/001/IS Beromun, powder and solvent for solution for infusion, 1 mg Iceland 9.8.2004 EU/1/99/100/001-002/IS Cetrotide, powder for solution for injection, 0,25 mg Iceland 15.9.2004 EU/1/99/100/001-003 Cetrotide Liechtenstein 30.9.2004 EU/1/99/100/003/IS Cetrotide, powder for solution for injection, 3 mg Iceland 15.9.2004 EU/1/99/103/001/IS Refacto, powder and solvent for sol. for injection, 250 a.e. Iceland 19.8.2004 EU/1/99/103/001/NO-004/NO ReFacto Norway 16.8.2004 EU/1/99/103/001-004 ReFacto Liechtenstein 30.9.2004 EU/1/99/103/002/IS Refacto, powder and solvent for sol. for injection, 500 a.e. Iceland 19.8.2004 EU/1/99/103/003/IS Refacto, powder and solvent for sol. for injection, 1 000 a.e. Iceland 19.8.2004 EU/1/99/103/004/IS Refacto, powder and solvent for sol. for injection, 2 000 a.e. Iceland 19.8.2004 EU/1/99/104/001 Procomvax Liechtenstein 30.9.2004 EU/1/99/104/001/IS Procomvax, suspension for injection Iceland 2.9.2004 EU/1/99/107/001/IS Rebetol, capsule, hard, 200 mg Iceland 29.9.2004 EU/1/99/107/001/NO-003/NO Rebetol Norway 28.9.2004 EU/1/99/107/001-003 Rebetol Liechtenstein 30.9.2004 EU/1/99/108/001 Ferriprox Liechtenstein 30.9.2004 EU/1/99/108/001/IS Ferriprox, film coated tablet, 500 mg Iceland 22.9.2004 EU/1/99/108/001/NO Ferriprox Norway 27.9.2004 EU/1/99/109/001/IS Integrilin, solution for infusion, 0,75 mg/ml Iceland 1.10.2004 EU/1/99/109/001/NO-002/NO Integrilin Norway 28.9.2004 EU/1/99/109/001-002 Integrilin Liechtenstein 30.9.2004 EU/1/99/109/002/IS Integrilin, solution for injection, 2 mg/ml Iceland 1.10.2004 EU/1/99/111/001-009 Stocrin Liechtenstein 31.7.2004 EU/1/99/112/001/IS Ziagen, film-coated tablet, 300 mg Iceland 16.9.2004 EU/1/99/112/001/NO-002/NO Ziagen Norway 18.9.2004 EU/1/99/112/002/IS Ziagen, oral liquid, 20 mg/ml Iceland 16.9.2004 EU/1/99/113/001/NO-004/NO Paxene Norway 11.11.2004 EU/1/99/113/001-004 Paxene Liechtenstein 30.11.2004 EU/1/99/113/001-004/IS Paxene, concentrate foer solution for infusion, 6 mg/ml Iceland 23.11.2004 EU/1/99/114/001/NO-003/NO Zeffix Norway 18.11.2004 EU/1/99/114/001-002/IS Zeffix, film-coated tablet, 100 mg Iceland 19.11.2004 EU/1/99/114/001-003 Zeffix Liechtenstein 30.11.2004 EU/1/99/114/003/IS Zeffix, oral solution, 5 mg/ml Iceland 19.11.2004 EU/1/99/116/001/NO-003/NO Remicade Norway 11.10.2004 EU/1/99/116/001-003 Remicade Liechtenstein 30.9.2004 EU/1/99/117/001/IS Synagis, powder and solvent fol sol. for injection, 50 mg/hgl Iceland 7.10.2004 EU/1/99/117/001/NO-002/NO Synagis Norway 8.10.2004 EU/1/99/117/001-002 Synagis Liechtenstein 30.9.2004 EU/1/99/117/002/IS Synagis, powder and solvent fol sol. for injection, 100 mg/hgl Iceland 7.10.2004 EU/1/99/118/001/NO-010/NO Arava Norway 4.11.2004 EU/1/99/118/001-004/IS Arava, tablet, 10 mg Iceland 8.11.2004 EU/1/99/118/001-010 Arava Liechtenstein 30.11.2004 EU/1/99/118/005-009/IS Arava, tablet, 20 mg Iceland 8.11.2004 EU/1/99/118/009/IS Arava, tablet, 100 mg Iceland 8.11.2004 EU/1/99/119/001 NovoRapid Liechtenstein 30.11.2004 EU/1/99/119/001/IS and 008/IS NovoRapid, solution for injection, 100 units/ml Iceland 11.11.2004 EU/1/99/119/001/NO EU/1/99/119/003/NO EU/1/99/119/005/NO-014/NO NovoRapid Norway 4.11.2004 EU/1/99/119/003 NovoRapid Liechtenstein 30.11.2004 EU/1/99/119/003/IS and 006/IS NovoRapid Penfill, solution for injection, 100 units/ml Iceland 11.11.2004 EU/1/99/119/005/IS and 007/IS NovoRapid NovoLet, solution for injection, 100 units/ml Iceland 11.11.2004 EU/1/99/119/005-014 NovoRapid Liechtenstein 30.11.2004 EU/1/99/119/012-014/IS NovoRapid InnoLet, solution for injection, 100 units/ml Iceland 11.11.2004 EU/1/99/125/001/NO-008/NO Zyprexa Velotab Norway 4.12.2004 EU/1/99/125/001-004/IS Zyprexa Velotab, orodispersible tablet Iceland 1.12.2004 EU/2/98/009/001-006/IS Suvaxyn Aujezky 738+O/W, emulsion for injection, Iceland 6.8.2004 EU/2/99/013/001/NO-002/NO Halocur Norway 21.12.2004

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 2004: EU-Number Product Country Date of extention EU/03/258/007-009/IS Avandamet 2 mg/1 000 mg, film-coated tablets Iceland 20.10.2004 EU/03/258/010-012/IS Avandamet 4 mg/1 000 mg, film-coated tablets Iceland 20.10.2004 EU/1/00/143/004/IS KOGENATE Bayer 250 IU Powder and solvent for solution for injection Iceland 23.10.2004 EU/1/00/143/004/NO-006/NO Kogenate Norway 21.10.2004 EU/1/00/143/005/IS KOGENATE Bayer 500 IU Powder and solvent for solution for injection Iceland 23.10.2004 EU/1/00/143/006/IS KOGENATE Bayer 1 000 IU Powder and solvent for solution for injection Iceland 23.10.2004 EU/1/01/193/002/IS MabCampath, conc. for sol. for inf. 30 mg/ml Iceland 26.11.2004 EU/1/02/206/009/NO-017/NO Arixtra Norway 8.12.2004 EU/1/02/207/009/NO-017/NO Quixidar Norway 8.12.2004 EU/1/03/258/007/NO-012/NO Avandamet Norway 24.9.2004 EU/1/97/046/016-030/IS Aprovel 75, 150 and 300 mg film-coated tablets Iceland 25.8.2004 EU/1/97/049/016-030/IS Karvea 75, 150 and 300 mg film-coated tablets Iceland 25.8.2004 EU/1/98/085/011-020/IS Karvezide, 150 mg/12,5 mg and 300 mg/12,5 mg film-coated tablets Iceland 25.8.2004 EU/1/98/086/011-020/IS CoAprovel 150 mg/12,5 mg and 300 mg/12,5 mg film-coated tablets Iceland 25.8.2004