EN Official Journal of the European Union C 233/37

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

(2006/C 233/10)

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 January — 30 June 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Annex IV List of withdrawn marketing authorisations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 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 January — 30 June 2004: EU-Number Product Country Date of authorisation EU/1/00/141/001/NO Myocet Norway 22.1.2004 EU/1/00/164/003-005 NutropinAq Liechtenstein 31.3.2004 EU/1/02/212/026 Vfend Liechtenstein 31.3.2004 EU/1/02/215/001-010/IS PritorPlus tablets 40 mg and 80 mg Iceland 10.2.2004 EU/1/03/263/001/NO-003/NO Dukoral Norway 11.5.2004 EU/1/03/263/001-003 Dukoral Liechtenstein 31.5.2004 EU/1/03/264/001 Zevalin Liechtenstein 31.1.2004 EU/1/03/264/001/IS Zevalin 1.6 mg/ml kit for radiopharmaceut. prep. Iceland 13.2.2004 EU/1/03/264/001/NO Zevalin Norway 2.2.2004 EU/1/03/265/001/NO-002/NO Bonviva Norway 24.3.2004 EU/1/03/265/001-002 Bonviva Liechtenstein 31.5.2004 EU/1/03/265/001-002/IS Bonviva filmc. tabl. 2.5 mg Iceland 23.3.2004 EU/1/03/266/001/NO-002/NO Ibandronic Acid Roche Norway 24.3.2004 EU/1/03/266/001-002 Ibandronic Acid Roche Liechtenstein 31.5.2004 EU/1/03/266/001-002/IS Ibandronic Acid Roche film. tabl. 2.5 mg Iceland 23.3.2004 EU/1/03/267/001/NO-007/NO Reyataz Norway 26.3.2004 EU/1/03/267/001-006/IS Reyataz capsule hard 100 mg, 150 mg, 200 mg Iceland 30.3.2004 EU/1/03/267/001-007 Reyataz Liechtenstein 31.3.2004 EU/1/03/267/007/IS Reyataz oral powder 50 mg/1.5 g Iceland 30.3.2004 EU/1/03/268/001/NO-003/NO Cholestagel Norway 24.3.2004 EU/1/03/268/001-003 Cholestagel Liechtenstein 31.3.2004 EU/1/03/268/001-003/IS Cholestagel filmc. tabl. 625 mg Iceland 5.4.2004 EU/1/03/269/001/IS Faslodex Iceland 7.4.2004 EU/1/03/269/001/NO Faslodex Norway 6.4.2004 EU/1/03/270/001/NO-002/NO Oxybutynin Nicobrand Norway 28.6.2004 EU/1/03/271/001/IS Advate powder for sol. for inj. 250 IU, 500 IU, 1000 IU, 150 Iceland 1.4.2004 EU/1/03/271/001/NO-004/NO Advate Norway 29.3.2004 EU/1/03/271/001-004 Advate Liechtenstein 31.5.2004 EU/1/04/272/001/NO-002/NO Photo Barr Norway 23.4.2004 EU/1/04/272/001-002 Photo Barr Liechtenstein 31.5.2004 EU/1/04/272/002/IS Photo Barr Powder for sol. for inj. 15 or 75 mg Iceland 23.4.2004 EU/1/04/273/001 Lysodren Liechtenstein 31.5.2004 EU/1/04/273/001/IS Lysodren tablets 500 mg Iceland 19.5.2004 EU/1/04/273/001/NO Lysodren Norway 26.5.2004 EU/1/04/274/001 Velcade Liechtenstein 31.5.2004 EU/1/04/274/001/IS Velcade powder for sol. for inj. 3.5 mg Iceland 26.5.2004 EU/1/04/274/001/NO Velcade Norway 25.5.2004 EU/1/04/275/001/NO-002/NO Litak Norway 14.5.2004 EU/1/04/275/001-002 Litak Liechtenstein 31.5.2004 EU/1/04/275/001-002/IS Litak Solution for inj. 2 mg/ml Iceland 14.5.2004 EU/1/04/276/001/NO-020/NO Abilify Norway 24.6.2004 EU/1/04/278/001/NO-009/NO Levemir Norway 14.6.2004 EU/1/04/278/001-009/IS Levemir Penfill/FlexPen/InnoLet, sol f. inj. Iceland 25.6.2004 EU/1/95/001/032 Gonal Liechtenstein 31.1.2004 EU/1/95/001/033-035 Gonal f Liechtenstein 31.3.2004 EU/1/97/031/045-046 NeoRecormon Liechtenstein 31.3.2004 EU/1/97/046/016-030 Aprovel Liechtenstein 31.5.2004 EU/1/97/049/016-030 Karvea Liechtenstein 31.5.2004 EU/1/97/054/006 Viracept Liechtenstein 31.5.2004 EU/1/98/066/014-018 Exelon Liechtenstein 31.3.2004 EU/1/98/085/011-020 Karvezide Liechtenstein 31.5.2004 EU/1/98/086/011-020 CoAprovel Liechtenstein 31.5.2004 EU/1/98/091/001-014 Kinzalmono Liechtenstein 31.1.2004 EU/1/98/092/014-018 Prometax Liechtenstein 31.3.2004 EU/1/99/099/001-006 Zerene Liechtenstein 31.5.2004 EU/1/99/113/003-004 Paxene Liechtenstein 31.1.2004 EU/2/00/022/009-012/IS Ibaflin oral gel 3% and 7.5% Iceland 22.1.2004 EU/2/00/022/013-017 Ibaflin Liechtenstein 31.3.2004 EU/2/02/032/001/IS Gallivac HVT IDB Frosen susp. And diluent for inj. Iceland 13.4.2004 EU/2/04/042/001/NO-004/NO Novem Norway 10.5.2004 EU/2/04/042/001-002/IS Novem sol. for inj. 5 mg/ml Iceland 31.3.2004 EU/2/04/042/001-004 Novem Liechtenstein 31.5.2004 EU/2/04/042/003-004/IS Novem sol. for inj. 20 mg/ml Iceland 31.3.2004 EU/2/04/043/001/IS Equilis StrepE lyophilisate and solvent for suspension Iceland 11.6.2004 EU/2/97/004/010 Metacam Liechtenstein 31.3.2004 EU/2/98/010/001-024 Econor Liechtenstein 31.5.2004 EU/2/99/011/001 Locatim Liechtenstein 31.5.2004 EU/2/99/014/001-011 Stronghold Liechtenstein 31.3.2004

ANNEX II 2. Renewed Marketing Authorisations The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January — 30 June 2004: EU-Number Product Country Date of authorisation EU/1/97/037/001/NO Vistide Norway 31.3.2004 EU/1/98/084/001/IS Simulect, powder and solvent for sol. for injection, 20 mg Iceland 27.1.2004 EU/1/98/084/002/IS Simulect, powder and solvent for sol. for injection, 10 mg Iceland 27.1.2004 EU/1/98/085/001-010 Karvezide Liechtenstein 31.1.2004 EU/1/98/086/001-003,007 and 009/IS CoAprovel, tablets, 150 mg/12,5 mg Iceland 23.1.2004 EU/1/98/086/004-006,008 and 010/IS CoAprovel, tablets, 300 mg/12,5 mg Iceland 23.1.2004 EU/1/98/086/001-010 CoAprovel Liechtenstein 31.1.2004 EU/1/98/087/001/NO-003/NO Infergen Norway 23.4.2004 EU/1/98/087/001-003 Infergen Liechtenstein 31.5.2004 EU/1/98/087/001-003/IS Infergen solution for injection, 9 micrograms Iceland 21.6.2004 EU/1/98/089/001-016/IS Pritor tablets, 20, 40 and 80 mg Iceland 2.2.2004 EU/1/98/089/001-016/NO Pritor tablets, 20, 40 and 80 mg Norway 30.1.2004 EU/1/98/089/001-016 Pritor Liechtenstein 31.1.2004 EU/1/98/090/001/NO-014/NO Micardis Norway 30.1.2004 EU/1/98/090/001-014 Micardis Liechtenstein 31.1.2004 EU/1/98/090/001-014/IS Micardis tablets, 20, 40 and 80 mg Iceland 2.2.2004 EU/1/98/091/001/NO-014/NO Kinzalmono Norway 30.1.2004 EU/1/98/091/001-014/IS Kinzalmono tablets, 20, 40 and 80 mg Iceland 2.2.2004 EU/1/98/095/001/NO-002/NO Emadine Norway 5.4.2004 EU/1/98/095/001-004 Emadine Liechtenstein 31.3.2004 EU/1/98/095/001-004/IS Emadine, eye drops, solution, 0,5 mg/ml Iceland 1.4.2004 EU/1/98/096/001-002/IS Temodal, capsule, hard, 5 mg Iceland 7.4.2004 EU/1/98/096/001/NO-008/NO Temodal Norway 6.4.2004 EU/1/98/096/001-008 Temodal Liechtenstein 31.3.2004 EU/1/98/096/003-004/IS Temodal, capsule, hard, 20 mg Iceland 7.4.2004 EU/1/98/096/005-006/IS Temodal, capsule, hard, 100 mg Iceland 7.4.2004 EU/1/98/096/007-008/IS Temodal, capsule, hard, 250 mg Iceland 7.4.2004 EU/1/99/097/001/NO Beromun Norway 8.6.2004 EU/1/99/098/001/NO-002/NO Zenapax Norway 14.5.2004 EU/1/99/098/001-002 Zenapax Liechtenstein 31.5.2004 EU/1/99/098/001-002/IS Zenepax concentrate for solution for infusion Iceland 23.6.2004 EU/1/99/099/001-003/IS Zerene, capsule, hard, 5 mg Iceland 28.4.2004 EU/1/99/099/004-006/IS Zerene, capsule, hard, 10 mg Iceland 28.4.2004 EU/1/99/099/001-006/NO Zerene 5 mg, 10 mg capsules Norway 29.4.2004 EU/1/99/101/001/NO Regranex Norway 30.4.2004 EU/1/99/101/001 Regranex Liechtenstein 31.5.2004 EU/1/99/101/001/IS Regranex, gel, 100 mcg/g Iceland 30.4.2004 EU/1/99/102/001-003 and 007/IS Sonata, capsule, hard, 5 mg Iceland 29.4.2004 EU/1/99/102/001/NO-008/NO Sonata Norway 29.4.2004 EU/1/99/102/001-008 Sonata Liechtenstein 31.5.2004 EU/1/99/102/004-006 and 008/IS Sonata, capsule, hard, 10 mg Iceland 29.4.2004 EU/1/99/110/001/NO-009/NO Sustiva Norway 24.5.2004 EU/1/99/110/001-009 Sustiva Liechtenstein 31.5.2004 EU/1/99/110/001-009/IS Sustiva filmcoated tablets, capsules and oral sol. Iceland 28.5.2004 EU/1/99/111/001-009/IS Stocrin tablets, capsules and oral sol. Iceland 21.5.2004 EU/1/99/111/001/NO-009/NO Stocrin Norway 24.5.2004 EU/1/99/111/001-009 Stocrin Liechtenstein 31.5.2004 EU/1/99/111/002/IS Stocrin, capsule, hard, 100 mg Iceland 21.5.2004 EU/1/99/111/003-004/IS Stocrin, capsule, hard, 200 mg Iceland 21.5.2004 EU/1/99/111/005/IS Stocrin, oral solution, 30 mg/ml Iceland 21.5.2004 EU/1/99/111/006-007/IS Stocrin, film-coated tablet, 300 mg Iceland 21.5.2004 EU/1/98/085/004-006, 008, 010, 017-020/IS Karvezide, tablets, 150 mg/12,5 mg Iceland 22.1.2004 EU/1/98/085/001-003, 007, 009, 011-015/IS Karvezide, tablets, 300 mg/12,5 mg Iceland 22.1.2004 EU/2/98/009/001/NO-006/NO Suvaxyn Aujeszky 783+ O/W Norway 14.4.2004 EU/2/98/009/001-006 Suvaxyn Aujeszky 783+ O/W Liechtenstein 31.3.2004 EU/2/99/011/001/IS Locatim oral solution Iceland 27.5.2004 EU/2/99/011/001/NO Locatim Norway 28.5.2004

ANNEX III 3. Extended Marketing Authorisations The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January — 30 June 2004: EU-Number Product Country Date of extention EU/1/01/198/007/NO-010/NO Glivec Norway 5.1.2004 EU/1/01/198/007-010/IS Glivec 100 mg and 400 mg filmcoated tablets Iceland 15.1.2004 EU/1/02/212/026/IS Vfend, powder for oral suspension 40 mg/ml Iceland 18.6.2004 EU/1/02/212/026/NO Vfend Norway 5.3.2004 EU/1/95/001/033/NO-035/NO Gonal-f Norway 24.3.2004 EU/1/95/001/033-035/IS GONAL-f, solution for injection in prefilled pen Iceland 19.3.2004 EU/1/96/012/009-010/IS Bondronat, film coated tablets 50 mg Iceland 7.1.2004 EU/1/97/031/045/NO-046/NO NeoRecormon Norway 23.3.2004 EU/1/97/031/045-046/IS NeoRecormon 30.000 IU Sol. for injection pref.syr. Iceland 30.3.2004 EU/1/97/046/016/NO-030/NO Aprovel Norway 30.3.2004 EU/1/97/049/016/NO-030/NO Karvea Norway 30.3.2004 EU/1/97/054/006/IS Viracept 625 mg film-coated tablets Iceland 28.5.2004 EU/1/97/054/006/NO Viracept Norway 21.5.2004 EU/1/98/085/011/NO-020/NO Karvezide Norway 23.6.2004 EU/1/98/086/011/NO-020/NO CoAprovel Norway 23.6.2004 EU/2/00/022/013/NO-017/NO Ibaflin Norway 24.3.2004 EU/2/97/004/010/NO Metacam Norway 11.5.2004

ANNEX IV 4. Withdrawn Marketing Authorisations The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January — 30 June 2004: EU-Number Product Country Date of withdrawal EU/1/00/158/001/NO-034/NO Opulis Norway 29.3.2004 EU/1/00/158/001-034 Opulis Liechtenstein 31.3.2004 EU/1/00/159/001/NO-034/NO Allex Norway 29.3.2004 EU/1/00/159/001-034 Allex Liechtenstein 31.3.2004 EU/1/00/159/001-034/IS Allex Iceland 10.3.2004 EU/1/02/208/001/NO-008/NO Xapit Norway 29.3.2004 EU/1/02/208/001-008 Xapit Liechtenstein 31.3.2004 EU/1/02/242/001/NO-024/NO Valdyn Norway 29.3.2004 EU/1/99/106/001-003 Cotronak Liechtenstein 31.3.2004