DA Den Europæiske Unions Tidende C 40/5

Medicinske specialiteter — Liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i første halvdel af 2007

(2008/C 40/05)

Underudvalg I — For frie varebevægelser

Under henvisning til afgørelse truffet af Det Blandede EØS-udvalg nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-udvalg til på sit møde den 28. september 2007 at notere sig følgende lister over markedsføringstilladelser for medicinske specialiteter udstedt i perioden 1. januar — 30. juni 2007:

BILAG I Liste over nye markedsføringstilladelser BILAG II Liste over fornyede markedsføringstilladelser BILAG III Liste over udvidede markedsføringstilladelser BILAG IV Liste over tilbagetrukne markedsføringstilladelser

BILAG I Liste over nye markedsføringstilladelser Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne i perioden 1. januar — 30. juni 2007: EU-nummer Produkt Land Udstedelsesdato EU/1/06/001-012/IS Diacomit Island 23.1.2007 EU/1/06/343/001-005 Baraclude Liechtenstein 30.4.2007 EU/1/06/360/001-010 Champix Liechtenstein 30.4.2007 EU/1/06/361/001/NO Luminity Norge 7.2.2007 EU/1/06/363/001-009 Sprycel Liechtenstein 30.4.2007 EU/1/06/364/001-005 Adrovance Liechtenstein 28.2.2007 EU/1/06/364/001-005/IS Adrovance Island 22.1.2007 EU/1/06/364/001-005/NO Adrovance Norge 14.2.2007 EU/1/06/365/001-003 Elaprase Liechtenstein 28.2.2007 EU/1/06/365/001-003/IS Elaprase Island 6.2.2007 EU/1/06/365/001-003/NO Elaprase Norge 30.1.2007 EU/1/06/366/001-004 Tandemact Liechtenstein 28.2.2007 EU/1/06/366/001-004/IS Tandemact Island 24.1.2007 EU/1/06/366/001-004/NO Tandemact Norge 30.1.2007 EU/1/06/367/001-012 Diacomit Liechtenstein 28.2.2007 EU/1/06/367/001-012/NO Diacomit Norge 9.2.2007 EU/1/06/368/001-002/IS, 011-019/IS Insulin Human Winthrop Rapid Island 15.2.2007 EU/1/06/368/001-002/NO, 011-019/NO Insulin Human Winthrop Rapid Norge 13.2.2007 EU/1/06/368/001-057 Insulin Human Winthrop Liechtenstein 28.2.2007 EU/1/06/368/003-004/IS, 020-028/IS Insulin Human Winthrop Basal Island 15.2.2007 EU/1/06/368/003-004/NO, 020-028/NO Insulin Human Winthrop Basal Norge 13.2.2007 EU/1/06/368/005-006/IS, 029-037/IS Insulin Human Winthrop Comb 15 Island 15.2.2007 EU/1/06/368/005-006/NO, 029-037/NO Insulin Human Winthrop Comb 15 Norge 13.2.2007 EU/1/06/368/007-008/IS, 038-046/IS Insulin Human Winthrop Comb 25 Island 15.2.2007 EU/1/06/368/007-008/NO, 038-046/NO Insulin Human Winthrop Comb 25 Norge 13.2.2007 EU/1/06/368/009-010/IS, 047-055/IS Insulin Human Winthrop Comb 50 Island 15.2.2007 EU/1/06/368/009-010/NO, 047-055/NO Insulin Human Winthrop Comb 50 Norge 13.2.2007 EU/1/06/368/056-057/IS Insulin Human Winthrop Infusat Island 15.2.2007 EU/1/06/368/056-057/NO Insulin Human Winthrop Infusat Norge 13.2.2007 EU/1/06/369/001-028 Irbesartan Hydrochlorothiazide BMS Liechtenstein 28.2.2007 EU/1/06/369/001-028/IS Irbesartan HCT BMS Island 16.2.2007 EU/1/06/369/001-028/NO Irbesartan HCT BMS Norge 15.2.2007 EU/1/06/370/001-024/IS Exforge Island 14.2.2007 EU/1/06/370/001-024/NO Exforge Norge 22.2.2007 EU/1/06/371/001-024/IS Dafiro Island 14.2.2007 EU/1/06/371/001-024/NO Dafiro Norge 5.3.2007 EU/1/06/372/001-024/IS Copalia Island 14.2.2007 EU/1/06/372/001-024/NO Copalia Norge 5.3.2007 EU/1/06/373/001-024/IS Imprida Island 14.2.2007 EU/1/06/373/001-024/NO Imprida Norge 5.3.2007 EU/1/06/374/001 Lucentis Liechtenstein 28.2.2007 EU/1/06/374/001/IS Lucentis Island 12.2.2007 EU/1/06/374/001/NO Lucentis Norge 7.2.2007 EU/1/06/375/001-033 Irbesartan BMS Liechtenstein 28.2.2007 EU/1/06/375/001-033/IS Irbesartan BMS Island 15.2.2007 EU/1/06/375/001-033/NO Irbesartan BMS Norge 15.2.2007 EU/1/06/376/001-033 Irbesartan Winthrop Liechtenstein 28.2.2007 EU/1/06/376/001-033/IS Irbesartan Winthrop Island 16.2.2007 EU/1/06/376/001-033/NO Irbesartan Winthrop Norge 15.2.2007 EU/1/06/377/001-028 Irbesartan Hydrochlorothiazide Winthrop Liechtenstein 28.2.2007 EU/1/06/377/001-028/IS Irbesartan HCT Winthrop Island 16.2.2007 EU/1/06/377/001-028/NO Irbesartan HCT Winthrop Norge 15.2.2007 EU/1/06/378/001-016 Inovelon Liechtenstein 28.2.2007 EU/1/06/378/001-016/IS Inovelon Island 25.2.2007 EU/1/06/378/001-016/NO Inovelon Norge 15.2.2007 EU/1/06/379/001 Cystadane Liechtenstein 28.2.2007 EU/1/06/379/001/IS Cystadane Island 23.2.2007 EU/1/06/379/001/NO Cystadane Norge 27.2.2007 EU/1/06/380/001 Prezista Liechtenstein 28.2.2007 EU/1/06/380/001/IS Prezista Island 21.2.2007 EU/1/06/380/001/NO Prezista Norge 26.2.2007 EU/1/06/381/001-008 Daronrix Liechtenstein 30.4.2007 EU/1/06/381/001-008/IS Daronrix Island 26.3.2007 EU/1/06/381/001-008/NO Daronrix Norge 20.4.2007 EU/1/07/382/001-018 Xelevia Liechtenstein 30.4.2007 EU/1/07/382/001-018/IS Xelevia Island 11.4.2007 EU/1/07/382/001-018/NO Xelevia Norge 18.4.2007 EU/1/07/383/001-018 Januvia Liechtenstein 30.4.2007 EU/1/07/383/001-018/IS Januvia Island 10.4.2007 EU/1/07/383/001-018/NO Januvia Norge 18.4.2007 EU/1/07/384/001-002 Docetaxel Winthrop Liechtenstein 30.6.2007 EU/1/07/384/001-002/IS Docetaxel Winthrop Island 18.5.2007 EU/1/07/384/001-002/NO Docetaxel Winthrop Norge 10.5.2007 EU/1/07/385/001-004 Focetria Liechtenstein 30.6.2007 EU/1/07/385/001-004/IS Focetria Island 19.6.2007 EU/1/07/385/001-004/NO Focetria Norge 18.6.2007 EU/1/07/386/001-010 Toviaz Liechtenstein 30.6.2007 EU/1/07/386/001-010/IS Toviaz Island 24.5.2007 EU/1/07/386/001-010/NO Toviaz Norge 31.5.2007 EU/1/07/387/001-008 Advagraf Liechtenstein 30.6.2007 EU/1/07/387/001-008/IS Advagraf Island 16.5.2007 EU/1/07/387/001-008/NO Advagraf Norge 18.5.2007 EU/1/07/388/001 Sebivo Liechtenstein 30.6.2007 EU/1/07/388/001/IS Sebivo Island 24.5.2007 EU/1/07/388/001/NO Sebivo Norge 14.5.2007 EU/1/07/389/001-003 Orencia Liechtenstein 30.6.2007 EU/1/07/389/001-003/IS Orencia Island 18.6.2007 EU/1/07/389/001-003/NO Orencia Norge 19.6.2007 EU/1/07/390/001-004 Altargo Liechtenstein 30.6.2007 EU/1/07/390/001-004/IS Altargo Island 21.6.2007 EU/1/07/390/001-004/NO Altargo Norge 21.6.2007 EU/1/07/391/001-004 Revlimid Liechtenstein 30.6.2007 EU/1/07/394/001-006 Optaflu Liechtenstein 30.6.2007 EU/1/07/394/001-006/IS Optaflu Island 21.6.2007 EU/2/06/064/001-004 ProMeris Liechtenstein 28.2.2007 EU/2/06/064/001-004/IS ProMeris Island 18.1.2007 EU/2/06/064/001-004/NO ProMeris Norge 20.2.2007 EU/2/06/065/001-010 ProMeris Duo Liechtenstein 28.2.2007 EU/2/06/065/001-010/IS ProMeris Duo Island 18.1.2007 EU/2/06/065/001-010/NO ProMeris Duo Norge 20.2.2007 EU/2/06/066/001-012 Prac-Tic Liechtenstein 28.2.2007 EU/2/06/066/001-012/IS PRAC-TIC Island 21.1.2007 EU/2/06/066/001-012/NO Prac-tic Norge 23.1.2007 EU/2/06/067/001-002/IS Medicinal Oxygen Island 16.3.2007 EU/2/06/068/001-004 Ypozane Liechtenstein 28.2.2007 EU/2/06/068/001-004/IS Ypozane Island 26.1.2007 EU/2/06/068/001-004/NO Ypozane Norge 19.2.2007 EU/2/06/069/001 Cortavance Liechtenstein 28.2.2007 EU/2/06/069/001/IS Cortavance Island 23.2.2007 EU/2/06/069/001/NO Cortavance Norge 20.2.2007 EU/2/06/070/001-003 Meloxicam CEVA Liechtenstein 28.2.2007 EU/2/06/070/001-003/NO Meloxicam Ceva Norge 20.2.2007 EU/2/07/071/001-003 Slentrol Liechtenstein 30.6.2007 EU/2/07/071/001-003/IS Slentrol Island 26.4.2007 EU/2/07/071/001-003/NO Slentrol Norge 19.6.2007 EU/2/07/073/001-004 Nobilis Influenza H7N1 Liechtenstein 30.6.2007 EU/2/07/073/001-004/IS Nobilis Influenza H7N1 Island 1.6.2007 EU/2/07/074/001-006 Prilactone Liechtenstein 30.6.2007

BILAG II Liste over fornyede markedsføringstilladelser Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne i perioden 1. januar — 30. juni 2007: EU-nummer Produkt Land Fornyelsesdato EU/1/01/200/001 Viread Liechtenstein 28.2.2007 EU/1/01/200/001/IS Viread Island 22.1.2007 EU/1/01/200/001/NO Viread Norge 29.1.2007 EU/1/02/201/001-006/IS Protopic Island 8.1.2007 EU/1/02/202/001-006/IS Protopy Island 8.1.2007 EU/1/02/203/001-004 Kineret Liechtenstein 30.4.2007 EU/1/02/203/001-004/IS Kineret Island 22.3.2007 EU/1/02/203/001-004/NO Kineret Norge 18.4.2007 EU/1/02/204/001 Trisenox Liechtenstein 28.2.2007 EU/1/02/204/001/IS Trisenox Island 14.3.2007 EU/1/02/204/001/NO Trisenox Norge 22.3.2007 EU/1/02/205/001-002 Lumigan Liechtenstein 30.4.2007 EU/1/02/205/001-002/IS Lumigan Island 14.3.2007 EU/1/02/205/001-002/NO Lumigan Norge 29.3.2007 EU/1/02/206/001-020 Arixtra Liechtenstein 30.6.2007 EU/1/02/206/001-020/IS Arixtra Island 23.4.2007 EU/1/02/206/001-020/NO Arixtra Norge 18.5.2007 EU/1/02/207/001-020 Quixidar Liechtenstein 30.6.2007 EU/1/02/207/001-020/IS Quixidar Island 23.4.2007 EU/1/02/207/001-020/NO Quixidar Norge 18.5.2007 EU/1/02/209/001-008 Dynastat Liechtenstein 30.6.2007 EU/1/02/209/001-008/IS Dynastat Island 25.4.2007 EU/1/02/211/001-005 Dynepo Liechtenstein 30.6.2007 EU/1/02/211/001-005, 010-012/IS Dynepo Island 25.4.2007 EU/1/02/211/001-005, 010-012/NO Dynepo Norge 18.5.2007 EU/1/02/212/001-026 Vfend Liechtenstein 30.6.2007 EU/1/02/212/001-026/IS Vfend Island 16.5.2007 EU/1/02/212/001-026/NO Vfend Norge 23.5.2007 EU/1/02/213/001-016 MicardisPlus Liechtenstein 30.6.2007 EU/1/02/213/001-016/IS MicardisPlus Island 23.5.2007 EU/1/02/213/001-016/NO MicardisPlus Norge 18.6.2007 EU/1/02/214/001-010 Kinzalkomb Liechtenstein 30.6.2007 EU/1/02/214/001-010/IS Kinzalkomb Island 23.5.2007 EU/1/02/214/001-010/NO Kinzalkomb Norge 18.6.2007 EU/1/02/215/001-014 PritorPlus Liechtenstein 30.6.2007 EU/1/02/215/001-014/IS PritorPlus Island 13.6.2007 EU/1/02/215/001-014/NO PritorPlus Norge 18.6.2007 EU/1/02/216/001-002 Invanz Liechtenstein 30.4.2007 EU/1/02/216/001-002/IS Invanz Island 21.3.2007 EU/1/02/217/001-002 Opatanol Liechtenstein 30.6.2007 EU/1/02/217/001-002/IS Opatanol Island 19.6.2007 EU/1/02/217/001-002/NO Opatanol Norge 28.6.2007 EU/1/02/219/001-015 Ebixa Liechtenstein 30.6.2007 EU/1/02/220/001-005 Tracleer Liechtenstein 30.6.2007 EU/1/02/220/001-005/IS Tracleer Island 22.6.2007 EU/1/07/183/001, 004-005, 007-008, 011, 013, 015, 018-029/IS HBVAXPRO Island 21.2.2007 EU/1/96/014/001-003/IS Tritanrix HepH Island 21.2.2007 EU/1/96/027/001, 003-005/IS Hycamtin Island 9.1.2007 EU/1/97/030/028-084 Insuman Liechtenstein 28.2.2007 EU/1/97/030/033-037, 057-58, 69-72/IS Insuman Basal Island 16.2.2007 EU/1/97/030/033-037, 057-58, 69-72/NO Insuman Basal Norge 13.2.2007 EU/1/97/030/038-042, 59-60, 73-76/IS Insuman Comb 15 Island 16.2.2007 EU/1/97/030/038-042, 59-60, 73-76/NO Insuman Comb 15 Norge 13.2.2007 EU/1/97/030/043-047, 61-62, 77-80/IS Insuman Comb 25 Island 16.2.2007 EU/1/97/030/043-047, 61-62, 77-80/NO Insuman Comb 25 Norge 13.2.2007 EU/1/97/030/048-052, 63-64, 81-84/IS Insuman Comb 50 Island 16.2.2007 EU/1/97/030/048-052, 63-64, 81-84/NO Insuman Comb 50 Norge 13.2.2007 EU/1/97/030/053-054/IS Insuman Comb Infusat Island 16.2.2007 EU/1/97/030/053-054/NO Insuman Comb Infusat Norge 13.2.2007 EU/1/97/030/28-32, 55-56, 65-68/IS Insuman Rapid Island 16.2.2007 EU/1/97/030/28-32, 55-56, 65-68/NO Insuman Rapid Norge 13.2.2007 EU/1/97/032/001 Leukoscan Liechtenstein 30.6.2007 EU/1/97/032/001/IS Leukoscan Island 27.6.2007 EU/1/97/033/001-003 Avonex Liechtenstein 30.4.2007 EU/1/97/033/001-003/IS Avonex Island 13.3.2007 EU/1/97/033/001-003/NO Avonex Norge 20.3.2007 EU/1/97/035/001-004 Refludan Liechtenstein 30.4.2007 EU/1/97/035/001-004/IS Refludan Island 14.3.2007 EU/1/97/035/001-004/NO Refludan Norge 10.4.2007 EU/1/97/037/001 Vistide Liechtenstein 30.6.2007 EU/1/97/040/001-002 Teslascan Liechtenstein 30.6.2007 EU/1/97/040/001-002/IS Teslascan Island 19.6.2007 EU/2/01/030/001-004/NO Virbagen Omega Norge 14.3.2007 EU/2/02/032/001 Vaxxitek HVT+IBD Liechtenstein 30.6.2007 EU/2/96/002/001-003 Fevaxyn Pentofel Liechtenstein 30.4.2007 EU/2/96/002/001-003/IS Fevaxyn Pentofel Island 14.3.2007

BILAG III Liste over udvidede markedsføringstilladelser Følgende markedsføringstilladelser er blevet udvidet i EØS-EFTA-staterne i perioden 1. januar — 30. juni 2007: EU-nummer Produkt Land Udvidelsesdato EU/1/00/134/030-037 Lantus Liechtenstein 28.2.2007 EU/1/00/157/035-067 Azomyr Liechtenstein 30.6.2007 EU/1/00/157/035-067/IS Azomyr Island 22.5.2007 EU/1/00/157/035-067/NO Azomyr Norge 5.6.2007 EU/1/00/160/037-069 Aerius Liechtenstein 30.6.2007 EU/1/00/160/037-069/IS Aerius Island 22.5.2007 EU/1/00/160/037-069/NO Aerius Norge 5.6.2007 EU/1/00/161/035/067/IS Neoclarityn Island 22.5.2007 EU/1/00/161/035-067 Neoclarityn Liechtenstein 30.6.2007 EU/1/00/161/035-067/NO Neoclarityn Norge 5.6.2007 EU/1/01/184/069-073 Nespo Liechtenstein 30.6.2007 EU/1/01/184/069-073/IS Nespo Island 1.6.2007 EU/1/01/185/069-073 Aranesp Liechtenstein 30.6.2007 EU/1/01/185/069-073/IS Aranesp Island 25.5.2007 EU/1/02/211/010-012 Dynepo Liechtenstein 30.4.2007 EU/1/02/213/013-016 MicardisPlus Liechtenstein 28.2.2007 EU/1/02/215/013-014 PritorPlus Liechtenstein 28.2.2007 EU/1/03/251/002 Hepsera Liechtenstein 30.6.2007 EU/1/03/266/005-006 Bondenza Liechtenstein 30.4.2007 EU/1/04/276/036/IS Abilify Island 18.1.2007 EU/1/04/280/008 Yentreve Liechtenstein 30.4.2007 EU/1/04/281/002-005 Erbitux Liechtenstein 30.4.2007 EU/1/04/281/002-005/IS Erbitux Island 21.2.2007 EU/1/04/281/002-005/NO Erbitux Norge 14.3.2007 EU/1/04/307/011-013 Zonegran Liechtenstein 30.4.2007 EU/1/05/327/018 Exubera Liechtenstein 30.4.2007 EU/1/05/331/014-037 Ne juin upro Liechtenstein 28.2.2007 EU/1/06/332/004-006 Omnitrope Liechtenstein 30.6.2007 EU/1/06/332/004-006/IS Omnitrope Island 18.5.2007 EU/1/06/349/009-010 Avaglim Liechtenstein 30.6.2007 EU/1/06/360/011 Champix Liechtenstein 30.6.2007 EU/1/96/016/004 Norvir Liechtenstein 28.2.2007 EU/1/98/069/005a, 005b, 006a, 006b Plavix Liechtenstein 30.6.2007 EU/1/98/070/005a, 005b, 006a, 006b Iscover Liechtenstein 30.6.2007 EU/1/98/089/020-022 Pritor Liechtenstein 28.2.2007 EU/1/98/090/017-020 Micardis Liechtenstein 28.2.2007 EU/1/98/096/009-012 Temodal Liechtenstein 30.6.2007 EU/1/98/096/009-012/IS Temodal Island 22.5.2007 EU/1/98/096/009-012/NO Temodal Norge 29.5.2007 EU/1/99/111/010-011/NO Stocrin Norge 8.1.2007 EU/1/99/123/012 Renagel Liechtenstein 30.6.2007 EU/2/03/040/002 Gonazon Liechtenstein 28.2.2007 EU/2/03/040/002/IS Gonazon Island 29.1.2007 EU/2/03/040/002/NO Gonazon Norge 20.2.2007 EU/2/04/044/006 Aivlosin Liechtenstein 30.4.2007 EU/2/04/045/005-006 Previcox Liechtenstein 28.2.2007 EU/2/04/045/007 Previcox Liechtenstein 30.4.2007 EU/2/04/045/007/IS Previcox Island 21.3.2007 EU/2/97/004/024-025 Metacam Liechtenstein 30.4.2007 EU/2/97/004/026-028 Metacam Liechtenstein 30.6.2007