DA Den Europæiske Unions Tidende C 356/22

Medicinske specialiteter — liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i første halvdel af 2012

2014/C 356/07

Underudvalg I for frie varebevægelser

Til Det Blandede EØS-Udvalgs underretning

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 15. juli 2013 at notere sig følgende lister over markedsføringstilladelser for medicinske specialiteter udstedt i perioden 1. januar-30. juni 2011:

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 V Liste over suspenderede markedsføringstilladelser

BILAG I Liste over nye markedsføringstilladelser Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne i perioden 1. januar-30. juni 2012: EU-nummer Vare Land Godkendelsens dato EU/1/11/711/001-030 Matever Norge 1.6.2012 EU/1/11/712/001-028 Levetiracetam Accord Norge 13.4.2012 EU/1/11/713/001-040 Levetiracetam Actavis Norge 16.4.2012 EU/1/11/715/001-002 Plenadren Island 23.4.2012 EU/1/11/721/001-021 Paglitaz Norge 13.4.2012 EU/1/11/721/001-021 Paglitaz Island 17.4.2012 EU/1/11/722/001-030 Pioglitazone Accord Norge 11.4.2012 EU/1/11/722/001-030 Pioglitazon Accord Liechtenstein 30.4.2012 EU/1/11/722/001-030 Pioglitazone Accord Island 20.4.2012 EU/1/11/723/001-021 Pioglitazone Krka Norge 23.5.2012 EU/1/11/723/001-021 Pioglitazone Krka Island 20.4.2012 EU/1/11/727/001 Mercatopurine Nova lab. Norge 19.4.2012 EU/1/11/727/001 Mercaptopurine Nova Laboratories Island 3.4.2012 EU/1/11/727/001 Mercatopurine Nova Laboratories Liechtenstein 30.4.2012 EU/1/11/729/001-006 Onduarp Norge 8.5.2012 EU/1/11/730/001-060 Rasitrio Island 3.2.2012 EU/1/11/738/001-003 Levetiracetam Actavis Gr. Norge 1.3.2012 EU/1/11/739/001-008 Dasselta Norge 16.1.2012 EU/1/11/740/001 Ameluz Island 5.1.2012 EU/1/11/740/001 Ameluz Norge 16.1.2012 EU/1/11/741/001 Levetiracetam SUN Norge 27.1.2012 EU/1/11/741/001 Levetiracetam Sun Island 9.1.2012 EU/1/11/742/001-010 Efavirenz Teva Norge 13.2.2012 EU/1/11/742/001-010 Efavirenz Teva Island 24.1.2012 EU/1/11/742/001-010 Efavirenz Teva Liechtenstein 29.2.2012 EU/1/11/743/001-015 Repaglinide Accord Norge 13.2.2012 EU/1/11/743/001-015 Repaglinide Accord Island 19.1.2012 EU/1/11/743/001-015 Repaglinide Accord Liechtenstein 29.2.2012 EU/1/11/744/001-002 Topotecan Eagle Island 22.1.2012 EU/1/11/744/001-002 Topotecan Eagle Liechtenstein 29.2.2012 EU/1/11/745/001-009 Desloratadine Actavis Island 3.2.2012 EU/1/11/745/001-009 Desloratadine Actavis Norge 13.2.2012 EU/1/11/746/001-012 Desloratadine ratiopharm Norge 13.2.2012 EU/1/11/746/001-012 Desloratadine ratiopharm Island 3.2.2012 EU/1/11/746/001-012 Desloratadine ratiopharm Liechtenstein 29.2.2012 EU/1/11/747/001 Colobreathe Island 29.2.2012 EU/1/11/747/001 Colobreathe Liechtenstein 29.2.2012 EU/1/11/748/001-006 Docetaxel Mylan Island 7.2.2012 EU/1/11/748/001-006 Docetaxel Mylan Liechtenstein 29.2.2012 EU/1/11/749/001-002 Caprelsa Liechtenstein 30.4.2012 EU/1/11/749/001-003 Caprelsa Island 9.3.2012 EU/1/11/749/001-002 Caprelsa Norge 13.3.2012 EU/1/12/750/001 Esmya Norge 30.3.2012 EU/1/12/750/001 Esmya Island 14.3.2012 EU/1/12/750/001 Esmya Liechtenstein 30.4.2012 EU/1/12/751/001 Zelboraf Norge 14.3.2012 EU/1/12/751/001 Zelboraf Island 7.3.2012 EU/1/12/751/001 Zelboraf Liechtenstein 29.2.2012 EU/1/12/752/001 Vepacel Norge 1.3.2012 EU/1/12/752/001 Vepacel Island 9.3.2012 EU/1/12/752/001 Vepacel Liechtenstein 29.2.2012 EU/1/12/753/001-012 Signifor Norge 10.5.2012 EU/1/12/753/001-012 Signifor Island 24.5.2012 EU/1/12/753/001-012 Signifor Liechtenstein 30.6.2012 EU/1/12/754/001-021 Sepioglin Norge 10.4.2012 EU/1/12/754/001-021 Sepioglin Island 3.4.2012 EU/1/12/754/001-021 Sepioglin Liechtenstein 30.4.2012 EU/1/12/755/001-027 Pioglitazone Actavis Norge 13.4.2012 EU/1/12/755/001-027 Pioglitazone Actavis Island 30.4.2012 EU/1/12/756/001-027 Glidipion (ex Ogliton) Norge 13.4.2012 EU/1/12/756/001-027 Pioglitazone Actavis Group Island 13.4.2012 EU/1/12/756/001-027 Pioglitazone Actavis Group Liechtenstein 30.4.2012 EU/1/12/757/001-030 Pioglitazone Teva Norge 11.4.2012 EU/1/12/757/001-030 Pioglitazone Teva Island 23.4.2012 EU/1/12/758/001-030 Pioglitazone Teva Pharma Norge 17.4.2012 EU/1/12/758/001-030 Pioglitazone Teva Pharma Island 25.4.2012 EU/1/12/759/001-003 Zoledronic acid Actavis Norge 8.5.2012 EU/1/12/759/001-003 Zoledronic acid Actavis Island 16.5.2012 EU/1/12/759/001-003 Zoledronsäure Actavis Liechtenstein 30.4.2012 EU/1/12/760/001-002 Bronchitol Norge 18.5.2012 EU/1/12/760/001-002 Bronchitol Island 9.5.2012 EU/1/12/761/001-002 Capecitabine Teva Norge 30.5.2012 EU/1/12/761/001-002 Capecitabine Teva Island 20.5.2012 EU/1/12/761/001-002 Capecitabin Teva Liechtenstein 30.4.2012 EU/1/12/762/001-018 Capecitabine Accord Island 20.5.2012 EU/1/12/762/001-018 Capecitabin Accord Liechtenstein 30.4.2012 EU/1/12/763/001-018 Capecitabine Krka Island 16.5.2012 EU/1/12/763/001-018 Capecitabin Krka Liechtenstein 30.4.2012 EU/1/12/763/001-018 Capecitabine Krka Norge 14.6.2012 EU/1/12/764/001 Pixuvri Norge 14.6.2012 EU/1/12/764/001 Pixuvri Island 29.5.2012 EU/1/12/764/001 Pixuvri Liechtenstein 30.6.2012 EU/1/12/765/001-004 Sabervel Island 9.5.2012 EU/1/12/765/001-006 Sabervel Norge 8.5.2012 EU/1/12/765/001-006 Sabervel Liechtenstein 30.4.2012 EU/1/12/766/001 Sancuso Norge 10.5.2012 EU/1/12/766/001 Sancuso Island 20.5.2012 EU/1/12/766/001 Sancuso Liechtenstein 30.6.2012 EU/1/12/767/001-007 Nimenrix Norge 1.5.2012 EU/1/12/767/001-007 Nimenrix Island 16.5.2012 EU/1/12/768/001 Riluzole Zentiva Island 25.5.2012 EU/1/12/768/001 Riluzol Zentiva Liechtenstein 30.6.2012 EU/1/12/769/001-003 Docetaxel Accord Island 12.6.2012 EU/1/12/769/001-003 Docetaxel Accord Liechtenstein 30.6.2012 EU/1/12/770/001-004 Docetaxel Kabi Norge 19.6.2012 EU/1/12/770/001-004 Docetaxel Kabi Island 13.6.2012 EU/1/12/770/001-004 Docetaxel Kabi Liechtenstein 30.6.2012 EU/2/11/134/001-014 Inflacam Norge 6.1.2012 EU/2/11/135/001-003 Panacur AquaSol Norge 10.2.2012 EU/2/11/136/001 Truscient Norge 6.1.2012 EU/2/11/136/001 TruScient Island 12.1.2012 EU/2/11/137/001-015 Activyl Tick Plus Norge 13.2.2012 EU/2/11/137/001-015 Activyl Tick Plus Island 25.1.2012 EU/2/11/137/001-015 Activyl Tick Plus Liechtenstein 29.2.2012 EU/2/12/138/001-003 RevitaCAM Island 14.3.2012 EU/2/12/139/001-003 Zulvac 1 + 8 Bovis Norge 3.4.2012 EU/2/12/139/001-003 Zulvac 1 + 8 Bovis Island 4.4.2012 EU/2/12/139/001-003 Zulvac 1 + 8 Bovis Liechtenstein 30.4.2012

BILAG II Liste over fornyede markedsføringstilladelser Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2012: EU-nummer Vare Land Godkendelsens dato EU/1/01/197/001-005 Foscan Island 14.5.2012 EU/1/01/200/001-002 Viread Norge 6.1.2012 EU/1/01/200/001-002 Viread Island 5.1.2012 EU/1/02/209/001-008 Dynastat Norge 8.3.2012 EU/1/02/209/001-008 Dynastat Island 7.2.2012 EU/1/02/209/001-008 Dynastat Liechtenstein 29.2.2012 EU/1/02/212/001-026 Vfend Norge 6.3.2012 EU/1/02/212/001-026 Vfend Island 14.3.2012 EU/1/02/212/001-026 Vfend Liechtenstein 30.4.2012 EU/1/02/216/001-002 Invanz Norge 19.1.2012 EU/1/02/216/001-002 Invanz Island 20.1.2012 EU/1/02/216/001-002 Invanz Liechtenstein 29.2.2012 EU/1/02/220/001-006 Tracleer Norge 8.5.2012 EU/1/02/220/001-006 Tracleer Island 20.5.2012 EU/1/02/220/001-006 Tracleer Liechtenstein 30.4.2012 EU/1/02/222/001-005 Tamiflu Norge 8.3.2012 EU/1/02/222/001-005 Tamiflu Island 19.6.2012 EU/1/02/222/001-005 Tamiflu Liechtenstein 30.6.2012 EU/1/06/334/001-005 Evoltra Liechtenstein 30.4.2012 EU/1/06/347/001-008 Sutent Liechtenstein 29.2.2012 EU/1/06/366/005-022 Tandemact Norge 11.4.2012 EU/1/06/366/005-022 Tandemact Island 22.3.2012 EU/1/06/366/005-022 Tandemact Liechtenstein 30.4.2012 EU/1/06/367/001-012 Diacomit Norge 6.3.2012 EU/1/06/367/001-012 Diacomit Island 7.2.2012 EU/1/06/367/001-012 Diacomit Liechtenstein 29.2.2012 EU/1/06/370/001-039 Exforge Norge 16.1.2012 EU/1/06/370/001-039 EXFORGE Island 3.2.2012 EU/1/06/371/001-039 Dafiro Island 8.2.2012 EU/1/06/371/001-039 Dafiro Liechtenstein 29.2.2012 EU/1/06/372/001-039 Copalia Norge 11.1.2012 EU/1/06/373/001-039 Imprida Norge 16.1.2012 EU/1/06/373/001-039 Imprida Island 6.2.2012 EU/1/06/374/001 Lucentis Norge 17.1.2012 EU/1/06/374/001 Lucentis Island 12.1.2012 EU/1/06/376/001-033 Irbesartan Zentiva (ex-Winthrop) Norge 14.2.2012 EU/1/06/376/001-033 Irbesartan Zentiva Island 7.2.2012 EU/1/06/376/001-033 Irbesartan Winthrop Liechtenstein 29.2.2012 EU/1/06/377/001-028 Irbesartan HCT Zentiva (ex-Winthrop) Norge 16.4.2012 EU/1/06/377/001-028 Irbesartan HCT Zentiva Island 22.3.2012 EU/1/06/377/001-028 Irbesartan HCT Liechtenstein 30.4.2012 EU/1/06/378/001-017 Inovelon Norge 6.3.2012 EU/1/06/378/001-017 Inovelon Island 24.1.2012 EU/1/06/378/001-017 Inovelon Liechtenstein 29.2.2012 EU/1/06/379/001 Cystadane Island 9.3.2012 EU/1/06/379/001 Cystadane Liechtenstein 29.2.2012 EU/1/06/386/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088102, 113-150, 163-168 Insulin Human Winthrop Norge 6.1.2012 EU/1/07/382/001-018 Xelevia Norge 14.2.2012 EU/1/07/382/001-018 Xelevia Island 6.2.2012 EU/1/07/382/001-018 Xelevia Liechtenstein 29.2.2012 EU/1/07/383/001-018 Januvia Norge 26.3.2012 EU/1/07/383/001-018 Januvia Island 11.5.2012 EU/1/07/383/001-018 Januvia Liechtenstein 30.4.2012 EU/1/07/384/003-005 Docetaxel Winthrop Norge 10.4.2012 EU/1/07/384/003-005 Docetaxel Winthrop Island 23.3.2012 EU/1/07/384/003-005 Docetaxel Winthrop Liechtenstein 30.4.2012 EU/1/07/386/001-018 Toviaz Norge 11.4.2012 EU/1/07/386/001-018 Toviaz Island 10.4.2012 EU/1/07/386/001-018 Toviaz Liechtenstein 30.4.2012 EU/1/07/387/001-026 Advagraf Norge 2.5.2012 EU/1/07/387/001-026 Advagraf Island 9.5.2012 EU/1/07/387/001-026 Advagraf Liechtenstein 30.4.2012 EU/1/07/388/001-003 Sebivo Norge 8.5.2012 EU/1/07/388/001-003 Sebivo Island 16.5.2012 EU/1/07/388/001-003 Sebivo Liechtenstein 30.4.2012 EU/1/07/389/001-003 Orencia Norge 10.4.2012 EU/1/07/389/001-003 Orencia Island 10.4.2012 EU/1/07/389/001-003 Orencia Liechtenstein 30.4.2012 EU/1/07/390/001-004 Altargo Norge 8.5.2012 EU/1/07/390/001-004 Altargo Island 16.5.2012 EU/1/07/390/001-004 Altargo Liechtenstein 30.4.2012 EU/1/07/391/001-004 Revlimid Norge 3.5.2012 EU/1/07/391/001-004 Revlimid Island 9.5.2012 EU/1/07/391/001-004 Revlimid Liechtenstein 30.4.2012 EU/1/07/392/001-003 Circadin Norge 16.5.2012 EU/1/07/392/001-003 Circadin Island 10.5.2012 EU/1/07/392/001-003 Circadin Liechtenstein 30.6.2012 EU/1/07/394/001-009 Optaflu Norge 20.6.2012 EU/1/07/395/001-095 Invega Liechtenstein 30.6.2012 EU/1/07/396/001-003 Pergoveris Island 20.6.2012 EU/1/07/396/001-003 Pergoveris Liechtenstein 30.6.2012 EU/1/07/398/001-014 Optimark Norge 27.6.2012 EU/1/07/399/001-006 Aerinaze Norge 18.6.2012 EU/1/07/399/001-006 Aerinaze Liechtenstein 30.6.2012 EU/1/07/399/001-006 Aerinaze Island 20.6.2012 EU/1/07/400/008-013, 017-024 Mircera Island 7.6.2012 EU/1/07/400/008-013, 017-024 Mircera Norge 14.6.2012 EU/1/07/400/017-024 Mircera Liechtenstein 30.6.2012 EU/1/07/401/007-016 alli Norge 29.6.2012 EU/1/07/412/001-052 Abseamed Liechtenstein 30.6.2012 EU/1/07/423/001-003 Vectibix Norge 19.3.2012 EU/1/07/423/001-003 Vectibix Island 9.3.2012 EU/1/07/440/001-003 Tyverb Liechtenstein 30.4.2012 EU/1/07/440/001-006 Tyverb Norge 2.5.2012 EU/1/07/440/001-006 Tyverb Island 11.5.2012 EU/1/10/625/001&003 Arzerra Island 17.2.2012 EU/1/10/625/001&003 Arzerra Norge 18.5.2012 EU/1/10/628/001-004 Votrient Norge 19.6.2012 EU/1/10/628/001-004 Votrient Island 13.6.2012 EU/1/11/699/001-004 Fampyra Norge 19.6.2012 EU/1/11/699/001-004 Fampyra Island 13.6.2012 EU/1/11/699/001-004 Fampyra Liechtenstein 30.6.2012 EU/2/05/053/001-003 Naxcel Norge 14.2.2012 EU/2/06/068/001-004 Ypozane Norge 13.2.2012 EU/2/06/068/001-004 Ypozane Island 18.1.2012 EU/2/06/068/001-004 Ypozane Liechtenstein 30.4.2012 EU/2/06/070/001-008 Meloxidyl Island 13.1.2012 EU/2/07/071/001-003 SLENTROL Island 7.5.2012 EU/2/07/071/001-003 Slentrol Liechtenstein 30.4.2012 EU/2/07/072/001-004 Suprelorin Island 21.6.2012 EU/2/07/074/001-006 Prilactone Island 13.6.2012 EU/2/07/075/001-004 Circovac Liechtenstein 30.6.2012 EU/2/07/075/001-004 Circovac Island 4.6.2012

BILAG III Liste over udvidede markedsføringstilladelser Følgende markedsføringstilladelser er blevet udvidet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2012: EU-nummer Vare Land Godkendelsens dato EU/1/00/141/002 Myocet Liechtenstein 30.4.2012 EU/1/02/222/05 Tamiflu Island 6.2.2012 EU/1/03/262/009-010 Emend Norge 5.1.2012 EU/1/03/262/009-010 Emend Island 3.2.2012 EU/1/03/271/007-010 Advate Norge 23.1.2012 EU/1/03/271/007-010 Advate Island 17.1.2012 EU/1/05/318/003 Revatio Norge 13.4.2012 EU/1/05/318/003 Revatio Island 17.4.2012 EU/1/05/318/003 Revatio Liechtenstein 30.4.2012 EU/1/06/339/003 Preotact Liechtenstein 30.6.2012 EU/1/08/465/021 Clopidogrel Zentiva Liechtenstein 30.6.2012 EU/1/08/468/002 INTELENCE Island 3.1.2012 EU/1/08/470/018-019 Vimpat Norge 14.3.2012 EU/1/08/470/018-019 Vimpat Island 14.3.2012 EU/1/08/470/018-019 Vimpat Liechtenstein 30.4.2012 EU/1/08/472/011-021 Xarelto Norge 4.1.2012 EU/1/08/475/035-060 Olanzapin Mylan Liechtenstein 29.2.2012 EU/1/09/536/003-004 Topotecan Actavis Liechtenstein 30.4.2012 EU/1/09/551/013-027 Vizarsin Island 7.6.2012 EU/1/09/551/013-027 Vizarsin Liechtenstein 30.6.2012 EU/1/09/571/002 Pandemic influenza vaccine H5N1 Baxter Liechtenstein 30.4.2012 EU/1/11/667/004 Esbriet Liechtenstein 30.4.2012 EU/1/11/699/003-004 Fampyra Liechtenstein 30.4.2012 EU/1/11/701/029-032 Levetiracetam Teva Liechtenstein 30.6.2012 EU/1/11/703/003 Xgeva Liechtenstein 29.2.2012 EU/1/11/704/002 Victrelis Liechtenstein 30.4.2012 EU/1/11/720/002 Incivo Liechtenstein 30.6.2012 EU/1/97/044/009 Tasmar Liechtenstein 30.4.2012 EU/2/07/078/015-017 Rheumocam Norge 13.2.2012 EU/2/07/078/015-017 Rheumocam Island 7.2.2012 EU/2/07/078/015-017 Rheumocam Liechtenstein 29.2.2012 EU/2/08/085/002-006 Easotic Liechtenstein 30.4.2012 EU/2/08/090/027 Loxicom Liechtenstein 30.6.2012 EU/2/10/114/003 Hiprabovis IBR Marker Live Liechtenstein 29.2.2012 EU/2/97/004/049 Metacam Liechtenstein 29.2.2012

BILAG IV Liste over tilbagetrukne markedsføringstilladelser Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne i perioden 1. januar-30. juni 2012: EU-nummer Vare Land Tilbagetrækningsdato EU/1/02/255/001-002 Xigris Island 25.6.2012 EU/1/04/272/001-002 PhotoBarr Norge 24.5.2012 EU/1/04/272/001-002 Photobarr Island 20.5.2012 EU/1/04/272/001-002 PhotoBarr Liechtenstein 30.6.2012 EU/1/06/335/001 Valtropin Island 5.6.2012 EU/1/06/335/001 Valtropin Liechtenstein 30.6.2012 EU/1/06/351/001-003 Livensa Island 11.4.2012 EU/1/06/351/001-003 Livensa Liechtenstein 30.4.2012 EU/1/06/352/001-003 Intrinsa Liechtenstein 30.6.2012 EU/1/06/352/001-003 Intrinsa Island 23.6.2012 EU/1/09/534/001-007 Clopidogrel Hexal Island 2.3.2012 EU/1/09/534/001-007 Clopidgrel Hexal Liechtenstein 29.2.2012 EU/1/09/548/001-007 Clopidogrel Acino Pharma GmbH Island 2.3.2012 EU/1/09/548/001-007 Clopidgrel Acino Pharma GmbH Liechtenstein 29.2.2012 EU/1/09/549/001-007 Clopidogrel Acino Pharma Island 2.3.2012 EU/1/09/549/001-007 Clopidogrel Acino Pharma Liechtenstein 29.2.2012 EU/1/10/630/001-002 Docefrez Island 20.6.2012 EU/1/10/630/001-002 Docefrez Liechtenstein 30.6.2012 EU/1/97/035/003-004 Refludan Island 24.5.2012 EU/1/97/035/001-004 Refludan Norge 6.6.2012 EU/1/97/035/001-004 Refludan Liechtenstein 30.6.2012 EU/2/00/028/002-008 Zubrin Island 17.4.2012 EU/2/00/028/002-008 Zubrin Liechtenstein 30.4.2012 EU/2/03/040/001-002 Gonazon Norge 2.4.2012 EU/2/03/040/001-002 Gonazon Island 17.4.2012 EU/2/03/040/001-002 Gonazon Liechtenstein 30.4.2012 EU/2/06/060/001-002 Poulvac FluFend H5N3 RG Liechtenstein 30.6.2012