EN Official Journal of the European Union C 233/54

List of marketing authorisations granted by the EEA EFTA States for the first half of 2005

(2006/C 233/12)

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 2005:

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Annex IV List of withdrawn marketing authorisations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 2005: EU-Number Product Country Date of authorisation EU/1/00/146/028-029 Keppra Liechtenstein 31.3.2005 EU/1/00/149/001/NO Panretin Norway 28.2.2005 EU/1/01/171/011-012 Rapamune Liechtenstein 31.3.2005 EU/1/01/178/001/IS Targretin 75 mg, capsule, soft Iceland 31.1.2005 EU/1/01/183/019 HBVAXPRO Liechtenstein 31.5.2005 EU/1/01/184/045-056 Nespo Liechtenstein 31.3.2005 EU/1/01/185/045-056 Aranesp Liechtenstein 31.3.2005 EU/1/01/198/011-013 Glivec Liechtenstein 31.1.2005 EU/1/02/227/002 Neulasta Liechtenstein 31.3.2005 EU/1/02/228/002 Neupopeg Liechtenstein 31.3.2005 EU/1/02/237/005 Cialis Liechtenstein 31.1.2005 EU/1/02/239/025-030 Bextra Liechtenstein 31.1.2005 EU/1/02/246/003 Carbaglu Liechtenstein 31.5.2005 EU/1/04/285/021-028 Apidra Liechtenstein 31.5.2005 EU/1/04/296/001/IS Cymbalta 30 mg, Gastro-resistant capsule, hard Iceland 14.1.2005 EU/1/04/296/001/NO-004/NO Cymbalta Norway 11.1.2005 EU/1/04/296/001-004 Cymbalta Liechtenstein 31.1.2005 EU/1/04/296/002-005/IS Cymbalta 60 mg, Gastro-resistant capsule, hard Iceland 14.1.2005 EU/1/04/297/001/IS Xeristar 30 mg, Gastro-resistant tablet hard Iceland 14.1.2005 EU/1/04/297/001/NO-004/NO Xeristar Norway 11.1.2005 EU/1/04/297/001-004 Xeristar Liechtenstein 31.1.2005 EU/1/04/297/002-005/IS Xeristar 60 mg, Gastro-resistant tablet hard Iceland 14.1.2005 EU/1/04/298/001/NO-002/NO Kivexa Norway 11.1.2005 EU/1/04/298/001-002 Kivexa Liechtenstein 31.1.2005 EU/1/04/298/001-002/IS Kivexa 600 mg, film-coated tablet Iceland 11.1.2005 EU/1/04/299/001/NO-003/NO Fendrix Norway 15.2.2005 EU/1/04/299/001-003 Fendrix Liechtenstein 31.3.2005 EU/1/04/299/001-003/IS Fendrix 20 microg/0,5 ml, suspension for injection Iceland 25.2.2005 EU/1/04/300/001/NO-002/NO Avastin Norway 18.1.2005 EU/1/04/300/001-002 Avastin Liechtenstein 31.1.2005 EU/1/04/300/001-002/IS Avastin 25 mg/ml, concentrate for sol. For infusion Iceland 11.2.2005 EU/1/04/301/001/NO-005/NO Quintanrix Norway 1.3.2005 EU/1/04/301/001-005 Quintanrix Liechtenstein 31.3.2005 EU/1/04/301/001-005/IS Quintanrix, powder and solvent for susp. for injection Iceland 14.3.2005 EU/1/04/302/001/NO-003/NO Prialt Norway 17.3.2005 EU/1/04/302/001-003 Prialt Liechtenstein 31.3.2005 EU/1/04/302/001-003/IS Prialt, solution for injection Iceland 18.3.2005 EU/1/04/303/001/IS Orfadin 2 mg, capsule, hard Iceland 19.3.2005 EU/1/04/303/003/IS Orfadin 10 mg, capsule, hard Iceland 19.3.2005 EU/1/04/303/001/NO-003/NO Orfadin Norway 17.3.2005 EU/1/04/303/001-003 Orfadin Liechtenstein 31.3.2005 EU/1/04/303/002/IS Orfadin 5 mg, capsule, hard Iceland 19.3.2005 EU/1/04/304/001/NO-007/NO Azilect Norway 21.3.2005 EU/1/04/304/001-007 Azilect Liechtenstein 31.3.2005 EU/1/04/304/001-007/IS Azilect 1 mg, tablet Iceland 17.3.2005 EU/1/04/305/001 Truvada Liechtenstein 31.3.2005 EU/1/04/305/001/IS Truvada 245/200 mg, film-coated tablet Iceland 16.3.2005 EU/1/04/305/001/NO Truvada Norway 7.3.2005 EU/1/04/306/001 Aloxi Liechtenstein 31.5.2005 EU/1/04/306/001/IS Aloxi 0,25 mg/5 ml, solution for injection Iceland 7.4.2005 EU/1/04/306/001/NO Aloxi Norway 20.4.2005 EU/1/04/307/001/NO-004/NO Zonegran Norway 9.4.2005 EU/1/04/307/001-004 Zonegran Liechtenstein 31.5.2005 EU/1/04/307/003/IS Zonegran 25 mg, capsule, hard Iceland 6.4.2005 EU/1/04/307/003/IS Zonegran 50 mg, capsule, hard Iceland 6.4.2005 EU/1/05/308/001 Aclasta Liechtenstein 31.5.2005 EU/1/05/308/001/IS Aclasta 5 mg/ml, solution for infusion Iceland 9.5.2005 EU/1/05/308/001/NO Aclasta Norway 10.5.2005 EU/1/97/044/001-006/IS Tasmar Iceland 18.1.2005 EU/1/97/045/004 Helicobacter Test INFAI Liechtenstein 31.3.2005 EU/1/99/107/004 Rebetol Liechtenstein 31.3.2005 EU/1/99/120/001/NO-004/NO Ammonaps Norway 21.4.2005 EU/1/99/123/011 Renagel Liechtenstein 31.3.2005 EU/1/99/125/005-008 Zyprexa Velotab Liechtenstein 31.3.2005 EU/1/99/126/004-005 Enbrel Liechtenstein 31.3.2005 EU/1/99/126/006-011 Enbrel Liechtenstein 31.5.2005 EU/2/00/019/005-007 Eurifel FeLV Liechtenstein 31.5.2005 EU/2/03/037/001-004/IS ProteqFlu, powder and solvent for susp. for inj. Iceland 9.5.2005 EU/2/03/038/001-004/IS ProteqFlu-Te, powder and solvent for susp. for inj. Iceland 18.2.2005 EU/2/04/046/001-003/IS Nobivac Piro, suspension for injection Iceland 12.5.2005 EU/2/04/047/001/NO-002/NO Purevax RCPCh FeLV Norway 21.3.2005 EU/2/04/047/001-002 Purevax RCPCh FeLV Liechtenstein 31.3.2005 EU/2/04/047/001-002/IS Purevax RCPCh Fel V Iceland 30.6.2005 EU/2/04/048/001/NO-002/NO Purevax RCP FeLV Norway 21.3.2005 EU/2/04/048/001-002 Purevax RCP FeLV Liechtenstein 31.3.2005 EU/2/04/048/001-002/IS Purevax RCP FeL V Iceland 30.6.2005 EU/2/04/049/001/NO-002/NO Purevax RCCh Norway 21.3.2005 EU/2/04/049/001-002 Purevax RCCh Liechtenstein 31.3.2005 EU/2/04/050/001/NO-002/NO Purevax RCPCh Norway 21.3.2005 EU/2/04/050/001-002 Purevax RCPCh Liechtenstein 31.3.2005 EU/2/04/051/001/NO-002/NO Purevax RC Norway 21.3.2005 EU/2/04/051/001-002 Purevax RC Liechtenstein 31.3.2005 EU/2/04/051/001-002/IS Purevax RC, powder and solvent for susp. for inj. Iceland 30.6.2005 EU/2/04/052/001/NO-002/NO Purevax RCP Norway 21.3.2005 EU/2/04/052/001-002 Purevax RCP Liechtenstein 31.3.2005 EU/2/04/052/001-002/IS Purevax RCP, powder and solvent for susp. for injection Iceland 30.6.2005 EU/2/04/49/001-002/IS Purevax RCCh, powder and solvent for susp. for inj. Iceland 30.6.2005 EU/2/04/50/001-002/IS Purevax RCPCh, powder and solvent for susp. for inj. Iceland 30.6.2005 EU/2/05/053/001/IS Naxel 100 mg/ml, suspension for injection Iceland 9.6.2005 EU/2/05/053/001/NO Naxcel Norway 17.6.2005 EU/2/99/014/012 Stronghold Liechtenstein 31.1.2005 EU/2/99/015/001/NO Oxyglobin Norway 5.1.2005 EU/2/99/017/001-006/IS Ibraxion, emulsion for injection Iceland 10.5.2005

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 2005: EU-Number Product Country Date of renewal EU/1/00/129/001/NO-003/NO Azopt Norway 30.6.2005 EU/1/00/129/001-003/IS Azopt, eye drops, suspension, 1% Iceland 30.6.2005 EU/1/00/130/001/NO-002/NO Orgalutran Norway 4.4.2005 EU/1/00/130/001-002 Orgalutran Liechtenstein 31.3.2005 EU/1/00/130/001-002/IS Orgalutran Iceland 18.4.2005 EU/1/00/131/001/NO-050/NO PegIntron Norway 24.6.2005 EU/1/00/131/001-050/IS PegIntron Iceland 28.6.2005 EU/1/00/132/001/NO-050/NO ViraferonPeg Norway 24.6.2005 EU/1/00/132/001-050/IS ViraferonPeg Iceland 28.6.2005 EU/1/99/100/001/NO-003/NO Cetrotide Norway 4.1.2005 EU/1/99/120/001-002/IS Ammonaps, tablets, 500 mg Iceland 29.4.2005 EU/1/99/120/003-004/IS Ammonaps 940 mg/g, granules Iceland 29.4.2005 EU/1/99/122/001/NO-002/NO Thyrogen Norway 15.4.2005 EU/1/99/122/001-002/IS Thyrogen, powder for solution for injection, 0,9 mg Iceland 14.4.2005 EU/1/99/123/001/NO-011/NO Renagel Norway 4.2.2005 EU/1/99/123/001-004/IS Renagel, capsule, hard, 403 mg Iceland 25.2.2005 EU/1/99/123/001-010 Renagel Liechtenstein 31.3.2005 EU/1/99/123/005-007/IS Renagel, film-coated tablet, 400 mg Iceland 25.2.2005 EU/1/99/123/008-011/IS Renagel, film-coated tablet, 800 mg Iceland 25.2.2005 EU/1/99/124/001/IS Tractocile, solution for injection, 7,5 mg/ml Iceland 1.3.2005 EU/1/99/124/001/NO-002/NO Tractocile Norway 7.3.2005 EU/1/99/124/001-002 Tractocile Liechtenstein 31.3.2005 EU/1/99/124/002/IS Tractocile, concentrate for solution for infusion, 7,5 mg/ml Iceland 1.3.2005 EU/1/99/125/001-004 Zyprexa Velotab Liechtenstein 31.3.2005 EU/1/99/126/001/NO-005/NO Enbrel Norway 6.4.2005 EU/1/99/126/001-003 Enbrel Liechtenstein 31.3.2005 EU/1/99/126/001-005/IS Enbrel Iceland 15.4.2005 EU/1/99/127/001/NO-044/NO IntronA Norway 20.6.2005 EU/1/99/127/001-044/IS IntronA Iceland 27.6.2005 EU/1/99/128/001/NO-037/NO Viraferon Norway 20.6.2005 EU/1/99/128/001-037/IS Viraferon Iceland 27.6.2005 EU/2/00/018/001/IS Incurin, tablet, 1mg Iceland 10.5.2005 EU/2/00/018/001/NO Incurin Norway 16.6.2005 EU/2/00/019/001/NO-003/NO Eurifel FeLV Norway 31.5.2005 EU/2/00/019/001-003 Eurifel FeLV Liechtenstein 31.5.2005 EU/2/00/021/001/NO-002/NO Rabigen Norway 23.5.2005 EU/2/00/021/001-002/IS RABIGEN SAG2, oral suspension Iceland 9.5.2005 EU/2/99/013/001-002 Halocur Liechtenstein 31.1.2005 EU/2/99/013/001-002/IS Halocur 0.5 mg/ml, oral solution Iceland 18.2.2005 EU/2/99/014/001/NO-012/NO Stronghold Norway 6.1.2005 EU/2/99/014/001-011 Stronghold Liechtenstein 31.1.2005 EU/2/99/014/001-012/IS Stronghold spot on solution 6% and 12% Iceland 7.1.2005 EU/2/99/015/001 Oxyglobin Liechtenstein 31.1.2005 EU/2/99/015/001/IS Oxyglobin 13g/dl, solution for infusion Iceland 5.1.2005 EU/2/99/017/001/NO-006/NO Ibraxion Norway 2.6.2005 EU/2/99/017/001-006 Ibraxion Liechtenstein 31.5.2005

ANNEX IV 4. Withdrawn Marketing Authorisations The following marketing authorisations have been withdrawn in EEA EFTA States during the period 1 January — 31 June 2005: EU-Number Product Country Date of extention EU/1/01/171/011/NO-012/NO Rapamune Norway 2.2.2005 EU/1/01/171/011-012/IS Rapamune 5 mg filmcoated tablets Iceland 1.3.2005 EU/1/02/206/009-011/IS Arixtra 5mg/0,4 ml solution for injection Iceland 10.3.2005 EU/1/02/206/012-014/IS Arixtra 7,5mg/0,6 ml solution for injection Iceland 10.3.2005 EU/1/02/206/015-017/IS Arixtra 10mg/0,8 ml solution for injection Iceland 10.3.2005 EU/1/02/207/009-011/IS Quixidar 5mg/0,4 ml solution for injection Iceland 9.3.2005 EU/1/02/207/012-014/IS Quixidar 7,5mg/0,6 ml solution for injection Iceland 9.3.2005 EU/1/02/207/015-017/IS Quixidar 10mg/0,8 ml solution for injection Iceland 9.3.2005 EU/1/96/026/002/NO Invirase Norway 9.6.2005 EU/1/99/107/004/IS Rebetol, oral solution 40 mg/ml Iceland 22.3.2005 EU/1/99/107/004/NO Rebetol Norway 22.2.2005 EU/1/99/126/006/NO-011/NO Enbrel Norway 19.5.2005 EU/1/99/126/006-011/IS Enbrel, 50 mg Iceland 24.5.2005 EU/2/00/019/005/NO-007/NO Eurifel FeLV Norway 15.4.2005