EN Official Journal of the European Union C 356/22

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2012

2014/C 356/07

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 January-30 June 2012, at their meeting on 15 July 2013:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 List of new marketing authorisations The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2012: EU-Number Product Country Date of authorisation EU/1/11/711/001-030 Matever Norway 1.6.2012 EU/1/11/712/001-028 Levetiracetam Accord Norway 13.4.2012 EU/1/11/713/001-040 Levetiracetam Actavis Norway 16.4.2012 EU/1/11/715/001-002 Plenadren Iceland 23.4.2012 EU/1/11/721/001-021 Paglitaz Norway 13.4.2012 EU/1/11/721/001-021 Paglitaz Iceland 17.4.2012 EU/1/11/722/001-030 Pioglitazone Accord Norway 11.4.2012 EU/1/11/722/001-030 Pioglitazon Accord Liechtenstein 30.4.2012 EU/1/11/722/001-030 Pioglitazone Accord Iceland 20.4.2012 EU/1/11/723/001-021 Pioglitazone Krka Norway 23.5.2012 EU/1/11/723/001-021 Pioglitazone Krka Iceland 20.4.2012 EU/1/11/727/001 Mercatopurine Nova lab. Norway 19.4.2012 EU/1/11/727/001 Mercaptopurine Nova Laboratories Iceland 3.4.2012 EU/1/11/727/001 Mercatopurine Nova Laboratories Liechtenstein 30.4.2012 EU/1/11/729/001-006 Onduarp Norway 8.5.2012 EU/1/11/730/001-060 Rasitrio Iceland 3.2.2012 EU/1/11/738/001-003 Levetiracetam Actavis Gr. Norway 1.3.2012 EU/1/11/739/001-008 Dasselta Norway 16.1.2012 EU/1/11/740/001 Ameluz Iceland 5.1.2012 EU/1/11/740/001 Ameluz Norway 16.1.2012 EU/1/11/741/001 Levetiracetam SUN Norway 27.1.2012 EU/1/11/741/001 Levetiracetam Sun Iceland 9.1.2012 EU/1/11/742/001-010 Efavirenz Teva Norway 13.2.2012 EU/1/11/742/001-010 Efavirenz Teva Iceland 24.1.2012 EU/1/11/742/001-010 Efavirenz Teva Liechtenstein 29.2.2012 EU/1/11/743/001-015 Repaglinide Accord Norway 13.2.2012 EU/1/11/743/001-015 Repaglinide Accord Iceland 19.1.2012 EU/1/11/743/001-015 Repaglinide Accord Liechtenstein 29.2.2012 EU/1/11/744/001-002 Topotecan Eagle Iceland 22.1.2012 EU/1/11/744/001-002 Topotecan Eagle Liechtenstein 29.2.2012 EU/1/11/745/001-009 Desloratadine Actavis Iceland 3.2.2012 EU/1/11/745/001-009 Desloratadine Actavis Norway 13.2.2012 EU/1/11/746/001-012 Desloratadine ratiopharm Norway 13.2.2012 EU/1/11/746/001-012 Desloratadine ratiopharm Iceland 3.2.2012 EU/1/11/746/001-012 Desloratadine ratiopharm Liechtenstein 29.2.2012 EU/1/11/747/001 Colobreathe Iceland 29.2.2012 EU/1/11/747/001 Colobreathe Liechtenstein 29.2.2012 EU/1/11/748/001-006 Docetaxel Mylan Iceland 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 Iceland 9.3.2012 EU/1/11/749/001-002 Caprelsa Norway 13.3.2012 EU/1/12/750/001 Esmya Norway 30.3.2012 EU/1/12/750/001 Esmya Iceland 14.3.2012 EU/1/12/750/001 Esmya Liechtenstein 30.4.2012 EU/1/12/751/001 Zelboraf Norway 14.3.2012 EU/1/12/751/001 Zelboraf Iceland 7.3.2012 EU/1/12/751/001 Zelboraf Liechtenstein 29.2.2012 EU/1/12/752/001 Vepacel Norway 1.3.2012 EU/1/12/752/001 Vepacel Iceland 9.3.2012 EU/1/12/752/001 Vepacel Liechtenstein 29.2.2012 EU/1/12/753/001-012 Signifor Norway 10.5.2012 EU/1/12/753/001-012 Signifor Iceland 24.5.2012 EU/1/12/753/001-012 Signifor Liechtenstein 30.6.2012 EU/1/12/754/001-021 Sepioglin Norway 10.4.2012 EU/1/12/754/001-021 Sepioglin Iceland 3.4.2012 EU/1/12/754/001-021 Sepioglin Liechtenstein 30.4.2012 EU/1/12/755/001-027 Pioglitazone Actavis Norway 13.4.2012 EU/1/12/755/001-027 Pioglitazone Actavis Iceland 30.4.2012 EU/1/12/756/001-027 Glidipion (ex Ogliton) Norway 13.4.2012 EU/1/12/756/001-027 Pioglitazone Actavis Group Iceland 13.4.2012 EU/1/12/756/001-027 Pioglitazone Actavis Group Liechtenstein 30.4.2012 EU/1/12/757/001-030 Pioglitazone Teva Norway 11.4.2012 EU/1/12/757/001-030 Pioglitazone Teva Iceland 23.4.2012 EU/1/12/758/001-030 Pioglitazone Teva Pharma Norway 17.4.2012 EU/1/12/758/001-030 Pioglitazone Teva Pharma Iceland 25.4.2012 EU/1/12/759/001-003 Zoledronic acid Actavis Norway 8.5.2012 EU/1/12/759/001-003 Zoledronic acid Actavis Iceland 16.5.2012 EU/1/12/759/001-003 Zoledronsäure Actavis Liechtenstein 30.4.2012 EU/1/12/760/001-002 Bronchitol Norway 18.5.2012 EU/1/12/760/001-002 Bronchitol Iceland 9.5.2012 EU/1/12/761/001-002 Capecitabine Teva Norway 30.5.2012 EU/1/12/761/001-002 Capecitabine Teva Iceland 20.5.2012 EU/1/12/761/001-002 Capecitabin Teva Liechtenstein 30.4.2012 EU/1/12/762/001-018 Capecitabine Accord Iceland 20.5.2012 EU/1/12/762/001-018 Capecitabin Accord Liechtenstein 30.4.2012 EU/1/12/763/001-018 Capecitabine Krka Iceland 16.5.2012 EU/1/12/763/001-018 Capecitabin Krka Liechtenstein 30.4.2012 EU/1/12/763/001-018 Capecitabine Krka Norway 14.6.2012 EU/1/12/764/001 Pixuvri Norway 14.6.2012 EU/1/12/764/001 Pixuvri Iceland 29.5.2012 EU/1/12/764/001 Pixuvri Liechtenstein 30.6.2012 EU/1/12/765/001-004 Sabervel Iceland 9.5.2012 EU/1/12/765/001-006 Sabervel Norway 8.5.2012 EU/1/12/765/001-006 Sabervel Liechtenstein 30.4.2012 EU/1/12/766/001 Sancuso Norway 10.5.2012 EU/1/12/766/001 Sancuso Iceland 20.5.2012 EU/1/12/766/001 Sancuso Liechtenstein 30.6.2012 EU/1/12/767/001-007 Nimenrix Norway 1.5.2012 EU/1/12/767/001-007 Nimenrix Iceland 16.5.2012 EU/1/12/768/001 Riluzole Zentiva Iceland 25.5.2012 EU/1/12/768/001 Riluzol Zentiva Liechtenstein 30.6.2012 EU/1/12/769/001-003 Docetaxel Accord Iceland 12.6.2012 EU/1/12/769/001-003 Docetaxel Accord Liechtenstein 30.6.2012 EU/1/12/770/001-004 Docetaxel Kabi Norway 19.6.2012 EU/1/12/770/001-004 Docetaxel Kabi Iceland 13.6.2012 EU/1/12/770/001-004 Docetaxel Kabi Liechtenstein 30.6.2012 EU/2/11/134/001-014 Inflacam Norway 6.1.2012 EU/2/11/135/001-003 Panacur AquaSol Norway 10.2.2012 EU/2/11/136/001 Truscient Norway 6.1.2012 EU/2/11/136/001 TruScient Iceland 12.1.2012 EU/2/11/137/001-015 Activyl Tick Plus Norway 13.2.2012 EU/2/11/137/001-015 Activyl Tick Plus Iceland 25.1.2012 EU/2/11/137/001-015 Activyl Tick Plus Liechtenstein 29.2.2012 EU/2/12/138/001-003 RevitaCAM Iceland 14.3.2012 EU/2/12/139/001-003 Zulvac 1 + 8 Bovis Norway 3.4.2012 EU/2/12/139/001-003 Zulvac 1 + 8 Bovis Iceland 4.4.2012 EU/2/12/139/001-003 Zulvac 1 + 8 Bovis Liechtenstein 30.4.2012

ANNEX II List of renewed marketing authorisations The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2012: EU-Number Product Country Date of authorisation EU/1/01/197/001-005 Foscan Iceland 14.5.2012 EU/1/01/200/001-002 Viread Norway 6.1.2012 EU/1/01/200/001-002 Viread Iceland 5.1.2012 EU/1/02/209/001-008 Dynastat Norway 8.3.2012 EU/1/02/209/001-008 Dynastat Iceland 7.2.2012 EU/1/02/209/001-008 Dynastat Liechtenstein 29.2.2012 EU/1/02/212/001-026 Vfend Norway 6.3.2012 EU/1/02/212/001-026 Vfend Iceland 14.3.2012 EU/1/02/212/001-026 Vfend Liechtenstein 30.4.2012 EU/1/02/216/001-002 Invanz Norway 19.1.2012 EU/1/02/216/001-002 Invanz Iceland 20.1.2012 EU/1/02/216/001-002 Invanz Liechtenstein 29.2.2012 EU/1/02/220/001-006 Tracleer Norway 8.5.2012 EU/1/02/220/001-006 Tracleer Iceland 20.5.2012 EU/1/02/220/001-006 Tracleer Liechtenstein 30.4.2012 EU/1/02/222/001-005 Tamiflu Norway 8.3.2012 EU/1/02/222/001-005 Tamiflu Iceland 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 Norway 11.4.2012 EU/1/06/366/005-022 Tandemact Iceland 22.3.2012 EU/1/06/366/005-022 Tandemact Liechtenstein 30.4.2012 EU/1/06/367/001-012 Diacomit Norway 6.3.2012 EU/1/06/367/001-012 Diacomit Iceland 7.2.2012 EU/1/06/367/001-012 Diacomit Liechtenstein 29.2.2012 EU/1/06/370/001-039 Exforge Norway 16.1.2012 EU/1/06/370/001-039 EXFORGE Iceland 3.2.2012 EU/1/06/371/001-039 Dafiro Iceland 8.2.2012 EU/1/06/371/001-039 Dafiro Liechtenstein 29.2.2012 EU/1/06/372/001-039 Copalia Norway 11.1.2012 EU/1/06/373/001-039 Imprida Norway 16.1.2012 EU/1/06/373/001-039 Imprida Iceland 6.2.2012 EU/1/06/374/001 Lucentis Norway 17.1.2012 EU/1/06/374/001 Lucentis Iceland 12.1.2012 EU/1/06/376/001-033 Irbesartan Zentiva (ex-Winthrop) Norway 14.2.2012 EU/1/06/376/001-033 Irbesartan Zentiva Iceland 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) Norway 16.4.2012 EU/1/06/377/001-028 Irbesartan HCT Zentiva Iceland 22.3.2012 EU/1/06/377/001-028 Irbesartan HCT Liechtenstein 30.4.2012 EU/1/06/378/001-017 Inovelon Norway 6.3.2012 EU/1/06/378/001-017 Inovelon Iceland 24.1.2012 EU/1/06/378/001-017 Inovelon Liechtenstein 29.2.2012 EU/1/06/379/001 Cystadane Iceland 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 Norway 6.1.2012 EU/1/07/382/001-018 Xelevia Norway 14.2.2012 EU/1/07/382/001-018 Xelevia Iceland 6.2.2012 EU/1/07/382/001-018 Xelevia Liechtenstein 29.2.2012 EU/1/07/383/001-018 Januvia Norway 26.3.2012 EU/1/07/383/001-018 Januvia Iceland 11.5.2012 EU/1/07/383/001-018 Januvia Liechtenstein 30.4.2012 EU/1/07/384/003-005 Docetaxel Winthrop Norway 10.4.2012 EU/1/07/384/003-005 Docetaxel Winthrop Iceland 23.3.2012 EU/1/07/384/003-005 Docetaxel Winthrop Liechtenstein 30.4.2012 EU/1/07/386/001-018 Toviaz Norway 11.4.2012 EU/1/07/386/001-018 Toviaz Iceland 10.4.2012 EU/1/07/386/001-018 Toviaz Liechtenstein 30.4.2012 EU/1/07/387/001-026 Advagraf Norway 2.5.2012 EU/1/07/387/001-026 Advagraf Iceland 9.5.2012 EU/1/07/387/001-026 Advagraf Liechtenstein 30.4.2012 EU/1/07/388/001-003 Sebivo Norway 8.5.2012 EU/1/07/388/001-003 Sebivo Iceland 16.5.2012 EU/1/07/388/001-003 Sebivo Liechtenstein 30.4.2012 EU/1/07/389/001-003 Orencia Norway 10.4.2012 EU/1/07/389/001-003 Orencia Iceland 10.4.2012 EU/1/07/389/001-003 Orencia Liechtenstein 30.4.2012 EU/1/07/390/001-004 Altargo Norway 8.5.2012 EU/1/07/390/001-004 Altargo Iceland 16.5.2012 EU/1/07/390/001-004 Altargo Liechtenstein 30.4.2012 EU/1/07/391/001-004 Revlimid Norway 3.5.2012 EU/1/07/391/001-004 Revlimid Iceland 9.5.2012 EU/1/07/391/001-004 Revlimid Liechtenstein 30.4.2012 EU/1/07/392/001-003 Circadin Norway 16.5.2012 EU/1/07/392/001-003 Circadin Iceland 10.5.2012 EU/1/07/392/001-003 Circadin Liechtenstein 30.6.2012 EU/1/07/394/001-009 Optaflu Norway 20.6.2012 EU/1/07/395/001-095 Invega Liechtenstein 30.6.2012 EU/1/07/396/001-003 Pergoveris Iceland 20.6.2012 EU/1/07/396/001-003 Pergoveris Liechtenstein 30.6.2012 EU/1/07/398/001-014 Optimark Norway 27.6.2012 EU/1/07/399/001-006 Aerinaze Norway 18.6.2012 EU/1/07/399/001-006 Aerinaze Liechtenstein 30.6.2012 EU/1/07/399/001-006 Aerinaze Iceland 20.6.2012 EU/1/07/400/008-013, 017-024 Mircera Iceland 7.6.2012 EU/1/07/400/008-013, 017-024 Mircera Norway 14.6.2012 EU/1/07/400/017-024 Mircera Liechtenstein 30.6.2012 EU/1/07/401/007-016 alli Norway 29.6.2012 EU/1/07/412/001-052 Abseamed Liechtenstein 30.6.2012 EU/1/07/423/001-003 Vectibix Norway 19.3.2012 EU/1/07/423/001-003 Vectibix Iceland 9.3.2012 EU/1/07/440/001-003 Tyverb Liechtenstein 30.4.2012 EU/1/07/440/001-006 Tyverb Norway 2.5.2012 EU/1/07/440/001-006 Tyverb Iceland 11.5.2012 EU/1/10/625/001&003 Arzerra Iceland 17.2.2012 EU/1/10/625/001&003 Arzerra Norway 18.5.2012 EU/1/10/628/001-004 Votrient Norway 19.6.2012 EU/1/10/628/001-004 Votrient Iceland 13.6.2012 EU/1/11/699/001-004 Fampyra Norway 19.6.2012 EU/1/11/699/001-004 Fampyra Iceland 13.6.2012 EU/1/11/699/001-004 Fampyra Liechtenstein 30.6.2012 EU/2/05/053/001-003 Naxcel Norway 14.2.2012 EU/2/06/068/001-004 Ypozane Norway 13.2.2012 EU/2/06/068/001-004 Ypozane Iceland 18.1.2012 EU/2/06/068/001-004 Ypozane Liechtenstein 30.4.2012 EU/2/06/070/001-008 Meloxidyl Iceland 13.1.2012 EU/2/07/071/001-003 SLENTROL Iceland 7.5.2012 EU/2/07/071/001-003 Slentrol Liechtenstein 30.4.2012 EU/2/07/072/001-004 Suprelorin Iceland 21.6.2012 EU/2/07/074/001-006 Prilactone Iceland 13.6.2012 EU/2/07/075/001-004 Circovac Liechtenstein 30.6.2012 EU/2/07/075/001-004 Circovac Iceland 4.6.2012

ANNEX III List of extended marketing authorisations The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2012: EU-Number Product Country Date of authorisation EU/1/00/141/002 Myocet Liechtenstein 30.4.2012 EU/1/02/222/05 Tamiflu Iceland 6.2.2012 EU/1/03/262/009-010 Emend Norway 5.1.2012 EU/1/03/262/009-010 Emend Iceland 3.2.2012 EU/1/03/271/007-010 Advate Norway 23.1.2012 EU/1/03/271/007-010 Advate Iceland 17.1.2012 EU/1/05/318/003 Revatio Norway 13.4.2012 EU/1/05/318/003 Revatio Iceland 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 Iceland 3.1.2012 EU/1/08/470/018-019 Vimpat Norway 14.3.2012 EU/1/08/470/018-019 Vimpat Iceland 14.3.2012 EU/1/08/470/018-019 Vimpat Liechtenstein 30.4.2012 EU/1/08/472/011-021 Xarelto Norway 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 Iceland 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 Norway 13.2.2012 EU/2/07/078/015-017 Rheumocam Iceland 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

ANNEX IV List of withdrawn marketing authorisations The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2012: EU-Number Product Country Date of authorisation EU/1/02/255/001-002 Xigris Iceland 25.6.2012 EU/1/04/272/001-002 PhotoBarr Norway 24.5.2012 EU/1/04/272/001-002 Photobarr Iceland 20.5.2012 EU/1/04/272/001-002 PhotoBarr Liechtenstein 30.6.2012 EU/1/06/335/001 Valtropin Iceland 5.6.2012 EU/1/06/335/001 Valtropin Liechtenstein 30.6.2012 EU/1/06/351/001-003 Livensa Iceland 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 Iceland 23.6.2012 EU/1/09/534/001-007 Clopidogrel Hexal Iceland 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 Iceland 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 Iceland 2.3.2012 EU/1/09/549/001-007 Clopidogrel Acino Pharma Liechtenstein 29.2.2012 EU/1/10/630/001-002 Docefrez Iceland 20.6.2012 EU/1/10/630/001-002 Docefrez Liechtenstein 30.6.2012 EU/1/97/035/003-004 Refludan Iceland 24.5.2012 EU/1/97/035/001-004 Refludan Norway 6.6.2012 EU/1/97/035/001-004 Refludan Liechtenstein 30.6.2012 EU/2/00/028/002-008 Zubrin Iceland 17.4.2012 EU/2/00/028/002-008 Zubrin Liechtenstein 30.4.2012 EU/2/03/040/001-002 Gonazon Norway 2.4.2012 EU/2/03/040/001-002 Gonazon Iceland 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