EN Official Journal of the European Union C 233/21

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

(2006/C 233/08)

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 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Annex IV List of withdrawn marketing authorisations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 January — 30 June 2003: EU-Number Product Country Date of authorisation EU/1/00/131/031-050 PegIntron Liechtenstein 31.1.2003 EU/1/00/134/013-021 Lantus Liechtenstein 31.5.2003 EU/1/00/146/027 Keppra Liechtenstein 31.3.2003 EU/1/00/147/001/NO-008/NO Hexavac Norway 30.1.2003 EU/1/01/171/009-010 Rapamune Liechtenstein 31.1.2003 EU/1/01/176/004-006 Zometa Liechtenstein 31.5.2003 EU/1/01/179/001/NO Osteogent Protein 1 Norway 24.4.2003 EU/1/01/183/001/NO-017/NO HBVAXPRO Norway 5.3.2003 EU/1/01/188/004-006 Fabrazyme Liechtenstein 31.1.2003 EU/1/01/195/008-015 Liprolog Liechtenstein 31.3.2003 EU/1/02/201/005-006 Protopic Liechtenstein 31.5.2003 EU/1/02/202/005-006 Protopy Liechtenstein 31.5.2003 EU/1/02/216/002 Invanz Liechtenstein 31.5.2003 EU/1/02/224/001/NO-005/NO Ambirix Norway 8.1.2003 EU/1/02/226/001/IS InductOs Iceland 19.3.2003 EU/1/02/233/001-015 Insulatard Liechtenstein 31.1.2003 EU/1/02/238/001 Zavesca Liechtenstein 31.1.2003 EU/1/02/239/001/NO-024/NO Bextra Norway 9.4.2003 EU/1/02/239/001-010/IS Bextra tablets 10 mg* Iceland 22.5.2003 EU/1/02/239/001-024 Bextra Liechtenstein 31.5.2003 EU/1/02/239/011-020/IS Bextra tablets 20 mg* Iceland 22.5.2003 EU/1/02/239/021-024/IS Bextra tablets 40 mg* Iceland 22.5.2003 EU/1/02/240/001-003 Somavert Liechtenstein 31.1.2003 EU/1/02/242/001/NO-024/NO Valdyn Norway 9.4.2003 EU/1/02/242/001-024 Valdyn Liechtenstein 31.5.2003 EU/1/02/244/001/NO-024/NO Kudeq Norway 9.4.2003 EU/1/02/244/001-024 Kudeq Liechtenstein 31.5.2003 EU/1/02/245/001 Theryttrex Liechtenstein 31.1.2003 EU/1/02/245/001-002/IS Theryttrex radioact. precursor Iceland 7.2.2002 EU/1/02/246/001/IS Carbaglu dispersible tabl. Iceland 17.2.2003 EU/1/02/246/001/NO-002/NO Carbaglu Norway 6.3.2003 EU/1/03/248/001/NO-012/NO Levitra Norway 10.3.2003 EU/1/03/248/001-004/IS Levitra 5 mg Iceland 24.3.2003 EU/1/03/248/001-012 Levitra Liechtenstein 31.3.2003 EU/1/03/248/005-008/IS Levitra 10 mg Iceland 24.3.2003 EU/1/03/248/009-012/IS Levitra 20 mg Iceland 24.3.2003 EU/1/03/249/001/NO-012/NO Vivanza Norway 26.5.2003 EU/1/03/249/001-004/IS Vivanza tabl. 5 mg Iceland 24.3.2003 EU/1/03/249/001-012 Vivanza Liechtenstein 31.3.2003 EU/1/03/249/005-008/IS Vivanza tabl. 10 mg Iceland 24.3.2003 EU/1/03/249/009-012/IS Vivanza tabl. 20 mg Iceland 24.3.2003 EU/1/03/250/001 Ytracis Liechtenstein 31.5.2003 EU/1/03/250/001/IS Ytracis 1850 MBq/ml Iceland 16.4.2003 EU/1/03/250/001/NO Ytracis 1850 MBq/ml Norway 22.4.2003 EU/1/03/251/001 Hepsera Liechtenstein 31.3.2003 EU/1/03/251/001/IS Hepsera tabl. 10 mg Iceland 4.4.2003 EU/1/03/251/001/NO Hepsera Norway 26.3.2003 EU/1/03/252/001/NO-003/NO Fuzeon Norway 5.6.2003 EU/1/03/252/001-002/IS Fuzeon powder and solv. for sol. for inj. Iceland 20.6.2003 EU/1/03/252/003/IS Fuzeon powder for sol. for inj. Iceland 20.6.2003 EU/1/96/007/021-028 Humalog Liechtenstein 31.1.2003 EU/1/96/011/001-004 Caelyx Liechtenstein 31.3.2003 EU/1/97/054/001 and 003-005 Viracept Liechtenstein 31.3.2003 EU/1/98/069/004a, 4b Plavix Liechtenstein 31.3.2003 EU/1/98/070/004a, 4b Iscover Liechtenstein 31.3.2003 EU/1/98/084/002 Simulect Liechtenstein 31.3.2003 EU/1/99/103/004 ReFacto Liechtenstein 31.1.2003 EU/2/00/021/001/NO-002/NO Rabigen Norway 19.5.2003 EU/2/00/022/001/NO-004/NO Ibaflin Norway 19.5.2003 EU/2/00/022/001a, b, 002a, b Ibaflin Liechtenstein 31.3.2003 EU/2/00/022/003a, b, 004a, b Ibaflin Liechtenstein 31.3.2003 EU/2/00/022/005-012 Ibaflin Liechtenstein 31.3.2003 EU/2/00/024/001/NO Pruban Norway 6.5.2003 EU/2.2.20033/001/NO Dexdomitor Norway 16.1.2003 EU/2.2.20034/001/IS Nobivac Bb cat Iceland 21.1.2003 EU/2.2.20035/001-006 SevoFlo Liechtenstein 31.1.2003 EU/2.2.20036/001-002 Nobilis OR inac Liechtenstein 31.1.2003 EU/2.2.20036/001-002 Nobilis OR inac Norway 31.1.2003 EU/2.3.20037/001/NO-004/NO ProteqFlu Norway 24.4.2003 EU/2.3.20037/001-004 ProteqFlu Liechtenstein 31.3.2003 EU/2.3.20038/001/NO-004/NO ProteqFlu-Te Norway 24.4.2003 EU/2.3.20038/001-004 ProteqFlu-Te Liechtenstein 31.3.2003 EU/2.3.20039/001-012 Advocate Liechtenstein 31.5.2003 EU/2.3.20039/013/NO-018/NO Advocate Norway 25.6.2003 EU/2/97/004/001 and 003-008 Metacam Liechtenstein 31.3.2003 EU/2/97/005/008-009 Quadrisol Liechtenstein 31.1.2003

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 2003: EU-Number Product Country Date of renewal EU/1/96/006/001/NO-003/NO NovoSeven Norway 14.1.2003 EU/1/96/015/001/NO-002/NO Epivir Norway 31.1.2003 EU/1/97/032/001/IS LeukoScan p.f. sol. for inj. Iceland 29.1.2003 EU/1/97/039/001/NO-004/NO Cystagon Norway 3.3.2003 EU/1/97/039/001-002/IS Cystagon capsule, hard Iceland 29.1.2003 EU/1/97/039/003-004/IS Cystagon capsule, hard Iceland 29.1.2003 EU/1/97/040/001-002/IS Teslascan 0,01 mmol/ml solution for infusion Iceland 12.5.2003 EU/1/97/045/001, 006-007/IS Helicobacter INFAI powder for oral solution, 75 mg Iceland 12.5.2003 EU/1/97/045/008/IS Helicobacter INFAI powder for oral solution, 45 mg Iceland 12.5.2003 EU/1/97/046/001-003, -010, -013/IS Aprovel tabl. 75 mg Iceland 18.2.2003 EU/1/97/046/004-006, -011, -014/IS Aprovel tabl. 150 mg Iceland 18.2.2003 EU/1/97/046/007-009, 026, 030, 033/IS Aprovel tabl. 300 mg Iceland 18.2.2003 EU/1/97/047/001/IS BeneFix powd. and solv. inj. 250 IU Iceland 15.4.2003 EU/1/97/047/001-003 BeneFix Liechtenstein 31.3.2003 EU/1/97/047/002/IS BeneFix powd. and solv. inj. 500 IU Iceland 15.4.2003 EU/1/97/047/003/IS BeneFix powd. and solv. inj. 1000 IU Iceland 15.4.2003 EU/1/97/048/001-014 Infanrix HepB Liechtenstein 31.1.2003 EU/1/97/048/001-014/IS Infanrix HepB Iceland 11.2.2003 EU/1/97/049/001-003, -010, 013/IS Karvea tabl. 75 mg Iceland 12.2.2003 EU/1/97/049/004-006, -012, 015/IS Karvea tabl. 300 mg Iceland 12.2.2003 EU/1/97/049/004-006, -011, 014/IS Karvea tabl. 150 mg Iceland 12.2.2003 EU/1/97/050/001/NO Sifrol Norway 6.1.2003 EU/1/97/050/009/NO-012/NO Sifrol Norway 6.1.2003 EU/1/97/051/001-002/IS Mirapexin tab. 0,088 mg Iceland 31.1.2003 EU/1/97/051/003-004/IS Mirapexin tab. 0,18 mg Iceland 31.1.2003 EU/1/97/051/005-006/IS Mirapexin tab. 0,035 mg Iceland 31.1.2003 EU/1/97/051/007-008/IS Mirapexin tab. 0,7 mg Iceland 31.1.2003 EU/1/97/051/009-010/IS Mirapexin tab. 1,1 mg Iceland 31.1.2003 EU/1/97/052/001/NO-006/NO Daquiran Norway 28.1.2003 EU/1/97/052/009/NO-010/NO Daquiran Norway 28.1.2003 EU/1/97/053/001/NO-005/NO Cerezyme Norway 6.1.2003 EU/1/97/053/001-002/IS Cerezyme 200U Iceland 10.2.2003 EU/1/97/053/001-005 Cerezyme Liechtenstein 31.1.2003 EU/1/97/053/003-005/IS Cerezyme 400U Iceland 10.2.2003 EU/1/97/054/001/IS Viracept 50 mg/g oral powder Iceland 13.5.2003 EU/1/97/054/001/NO Viracept Norway 18.2.2003 EU/1/97/054/003/IS Viracept tablets 250 mg Iceland 13.5.2003 EU/1/97/054/003/NO-005/NO Viracept Norway 18.2.2003 EU/1/97/054/005/IS Viracept film coated tablets 250 mg Iceland 13.5.2003 EU/1/97/055/001/IS Viramune tabl. 200 mg Iceland 10.4.2003 EU/1/97/055/001/NO-002/NO Viramune Norway 6.3.2003 EU/1/97/055/001-002 Viramune Liechtenstein 31.3.2003 EU/1/97/055/002/IS Viramune mixt. susp. 50 mg/5ml Iceland 10.4.2003 EU/1/97/057/001 Quadramet Liechtenstein 31.3.2003 EU/1/97/057/001/IS Quadramet solution for injection 1,3 GB/ml Iceland 16.5.2003 EU/1/97/057/001/NO Quadramet Norway 5.5.2003 EU/1/98/065/001/NO-002/NO Optison Norway 20.6.2003 EU/1/98/065/001-002 Optison Liechtenstein 31.5.2003 EU/1/98/065/001-002/IS Optison, solution for injection Iceland 25.6.2003 EU/2/98/007/001-003 Clomicalm Liechtenstein 31.5.2003 EU/2/98/008/001/NO-004/NO Neocolipor Norway 18.6.2003 EU/2/98/008/001-004 Neocolipor Liechtenstein 31.5.2003

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 2003: EU-Number Product Country Date of extention EU/1/00/146/027/NO Keppra Norway 18.3.2003 EU/1/01/171/009-010/IS Rapamune filmc. tablets 2 mg Iceland 11.6.2003 EU/1/01/171/009-010/NO Rapamune Norway 29.1.2003 EU/1/01/176/004/NO-006/NO Zometa Norway 29.4.2003 EU/1/01/176/004-006/IS Zometa, concentrate for sol. for infus Iceland 22.3.2003 EU/1/96/015/003/NO Epivir Norway 4.2.2003 EU/1/98/084/002/NO Simulect Norway 18.3.2003 EU/1/99/103/004/NO ReFacto Norway 13.3.2003 EU/1/99/127/040/NO-044/NO Introna Norway 21.1.2003 EU/2/00/022/009/NO-12/NO Ibaflin Norway 18.6.2003