EN Official Journal of the European Union C 391/3

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2013

2014/C 391/03

Subcommitee 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 2013, at their meeting on 4 April 2014:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 2013: EU-Number Product Country Date of authorisation EU/1/12/788/001-006 Seebri Breezhaler Liechtenstein 30.4.2013 EU/1/12/789/001-006 Enurev Breezhaler Liechtenstein 30.4.2013 EU/1/12/790/001-006 Tovanor Breezhaler Liechtenstein 30.4.2013 EU/1/12/791/001 Glybera Liechtenstein 30.4.2013 EU/1/12/795/001-010 Forxiga Liechtenstein 30.4.2013 EU/1/12/797/001-002 Eylea Liechtenstein 30.4.2013 EU/1/12/803/001-002 NexoBrid Liechtenstein 30.4.2013 EU/1/12/803/001-002 NexoBrid Iceland 14.1.2013 EU/1/12/803/001-002 NexoBrid Norway 11.1.2013 EU/1/12/804/001-016 BindRen Liechtenstein 30.4.2013 EU/1/12/804/001-016 BindRen Iceland 8.2.2013 EU/1/12/804/001-016 BindRen Norway 27.2.2013 EU/1/12/805 Amyvid Liechtenstein 28.2.2013 EU/1/12/805/001-004 AMYViD Iceland 6.2.2013 EU/1/12/805/001-004 AMYViD Norway 4.2.2013 EU/1/12/806/001-005 Ryzodeg Liechtenstein 28.2.2013 EU/1/12/806/001-005 Ryzodeg Iceland 20.2.2013 EU/1/12/806/001-005 Ryzodeg Norway 12.2.2013 EU/1/12/807/001-009 Tresiba Liechtenstein 28.2.2013 EU/1/12/807/001-009 Tresiba Iceland 20.2.2013 EU/1/12/807/001-009 Tresiba Norway 12.2.2013 EU/1/12/808/001-040 Imatinib Teva Liechtenstein 28.2.2013 EU/1/12/808/001-040 Imatinib Teva Iceland 5.2.2013 EU/1/12/808/001-040 Imatinib Teva Norway 22.1.2013 EU/1/12/809/001-014 Betmiga Liechtenstein 28.2.2013 EU/1/12/809/001-014 Betmiga Iceland 10.1.2013 EU/1/12/809/001-014 Betmiga Norway 17.1.2013 EU/1/12/810 Krystexxa Liechtenstein 30.4.2013 EU/1/12/810/001 Krystexxa Iceland 14.1.2013 EU/1/12/810/001 Krystexxa Norway 25.1.2013 EU/1/12/811/001-005 Lyxumia Iceland 12.2.2013 EU/1/12/811/001-005 Lyxumia Norway 12.2.2013 EU/1/12/812 Bexsero Liechtenstein 28.2.2013 EU/1/12/812/001-004 Bexsero Iceland 14.2.2013 EU/1/12/812/001-004 Bexsero Norway 4.2.2013 EU/1/12/814 Zaltrap Liechtenstein 28.2.2013 EU/1/12/814/001-003 Zaltrap Iceland 12.2.2013 EU/1/12/814/001-003 Zaltrap Norway 27.2.2013 EU/1/12/815/001-005 Selincro Liechtenstein 30.4.2013 EU/1/12/815/001-005 Selincro Iceland 19.3.2013 EU/1/12/815/001-005 Selincro Norway 11.3.2013 EU/1/13/813/001 Perjeta Liechtenstein 30.4.2013 EU/1/13/813/001 Perjeta Iceland 20.3.2013 EU/1/13/813/001 Perjeta Norway 9.4.2013 EU/1/13/817/001-041 Actelsar HCT Iceland 21.3.2013 EU/1/13/817/001-041 Actelsar HCT Norway 22.4.2013 EU/1/13/818/001-004 Bosulif Iceland 15.4.2013 EU/1/13/818/001-004 Bosulif Norway 30.4.2013 EU/1/13/819/001 JETREA Liechtenstein 30.4.2013 EU/1/13/819/001 JETREA Iceland 11.4.2013 EU/1/13/819/001 JETREA Norway 22.3.2013 EU/1/13/820/001-026 Maruxa Liechtenstein 30.6.2013 EU/1/13/820/001-026 Maruxa Norway 24.5.2013 EU/1/13/821/001-030 Tolucombi Liechtenstein 30.4.2013 EU/1/13/821/001-030 Tolucombi Iceland 21.3.2013 EU/1/13/821/001-030 Tolucombi Norway 22.3.2013 EU/1/13/823/001-002 Adasuve Norway 12.3.2013 EU/1/13/823/001-002 Adasuve Liechtenstein 30.4.2013 EU/1/13/823/001-002 Adasuve Iceland 18.3.2013 EU/1/13/824 Nemdatine Liechtenstein 30.4.2013 EU/1/13/824/001-020 Nemdatine Iceland 21.5.2013 EU/1/13/824/001-020 Nemdatine Norway 3.5.2013 EU/1/13/825 Imatinib Actavis Liechtenstein 30.6.2013 EU/1/13/825/001-018 Imatinib Actavis Iceland 16.5.2013 EU/1/13/825/001-018 Imatinib Actavis Norway 20.6.2013 EU/1/13/826 Memantine LEK Liechtenstein 30.4.2013 EU/1/13/826/001-011 Memantine LEK Iceland 21.5.2013 EU/1/13/826/001-011 Memantine LEK Norway 3.5.2013 EU/1/13/827 Memantine Mylan Liechtenstein 30.4.2013 EU/1/13/827/001-036 Memantine Mylan Iceland 21.5.2013 EU/1/13/827/001-036 Memantine Mylan Norway 3.5.2013 EU/1/13/828 Hexacima Liechtenstein 30.4.2013 EU/1/13/828/001-007 Hexacima Iceland 17.5.2013 EU/1/13/828/001-007 Hexacima Norway 15.5.2013 EU/1/13/829 Hexyon Liechtenstein 30.4.2013 EU/1/13/829/001-007 Hexyon Iceland 17.5.2013 EU/1/13/829/001-007 Hexyon Norway 15.5.2013 EU/1/13/830/001-002 Stribild Iceland 19.6.2013 EU/1/13/830/001-002 Stribild Norway 24.5.2013 EU/1/13/835/001-018 Voriconazole Accord Iceland 31.5.2013 EU/1/13/835/001-018 Voriconazole Accord Norway 31.5.2013 EU/1/13/836 Memantine ratiopharm Liechtenstein 30.6.2013 EU/1/13/836/001-023 Memantine ratiopharm Norway 25.6.2013 EU/1/13/840/001-005 HyQvia Iceland 27.5.2013 EU/1/13/840/001-005 HyQvia Norway 3.6.2013 EU/2/12/142/001-006 Cardalis Norway 20.6.2013 EU/2/12/144/001-004 Contacera Liechtenstein 28.2.2013 EU/2/12/144/001-004 Contacera Iceland 3.1.2013 EU/2/12/144/001-004 Contacera Norway 17.1.2013 EU/2/12/145/001-003 Kexxtone Liechtenstein 30.4.2013 EU/2/12/145/001-003 Kexxtone Iceland 27.2.2013 EU/2/12/145/001-003 Kexxtone Norway 8.3.2013 EU/2/12/146/001 Semintra Liechtenstein 30.4.2013 EU/2/12/146/001 Semintra Iceland 12.3.2013 EU/2/12/146/001 Semintra Norway 5.4.2013 EU/2/12/147/001-004 Pexion Liechtenstein 30.4.2013 EU/2/12/147/001-004 Pexion Iceland 19.3.2013 EU/2/12/147/001-004 Pexion Norway 8.3.2013 EU/2/13/148 Meloxidolor Liechtenstein 30.6.2013 EU/2/13/148/001-007 Meloxidolor Iceland 21.5.2013 EU/2/13/148/001-007 Meloxidolor Norway 22.4.2013 EU/2/13/149 ECOPORC SHIGA Liechtenstein 30.4.2013 EU/2/13/149/001-002 ECOPORC SHIGA Iceland 15.5.2013 EU/2/13/149/001-002 ECOPORC SHIGA Norway 13.5.2013 EU/2/13/150 Oncept IL-2 Liechtenstein 30.6.2013 EU/2/13/151/001-003 Equilis West Nile Iceland 27.6.2013

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 2013: EU-Number Product Country Date of authorisation EU/1/03/247 Forsteo Liechtenstein 30.4.2013 EU/1/03/247/001-002 Forsteo Iceland 19.2.2013 EU/1/03/247/001-002 Forsteo Norway 6.3.2013 EU/1/07/423 Vectibix Liechtenstein 30.4.2013 EU/1/07/423/001-003 Vectibix Iceland 5.2.2013 EU/1/07/423/001-003 Vectibix Norway 12.2.2013 EU/1/07/428/001 Abraxane Liechtenstein 30.4.2013 EU/1/07/428/001 Abraxane Iceland 5.2.2013 EU/1/07/428/001 Abraxane Norway 11.2.2013 EU/1/07/430/001-002 Atripla Liechtenstein 30.4.2013 EU/1/07/433/001 Nevanac Iceland 9.1.2013 EU/1/07/434 Avamys Liechtenstein 28.2.2013 EU/1/07/434/001-003 Avamys Iceland 11.1.2013 EU/1/07/434/001-003 Avamys Norway 14.1.2013 EU/1/07/435/001-018 Tesavel Liechtenstein 30.4.2013 EU/1/07/438/001-006 Myfenax Liechtenstein 30.4.2013 EU/1/07/439/001-006 Mycophenolate mofetil Teva Liechtenstein 30.4.2013 EU/1/07/440 Tyverb Liechtenstein 30.4.2013 EU/1/07/440/001-007 Tyverb Norway 15.5.2013 EU/1/08/441 Effentora Liechtenstein 30.4.2013 EU/1/08/441/001-010 Effentora Iceland 20.3.2013 EU/1/08/441/001-010 Effentora Norway 12.3.2013 EU/1/08/442/001-019 Pradaxa Norway 26.2.2013 EU/1/08/442/001-019 Pradaxa Liechtenstein 30.4.2013 EU/1/08/442/001-019 Pradaxa Iceland 15.2.2013 EU/1/08/443/001 Thalidomide Celgene Iceland 14.1.2013 EU/1/08/443/001 Thalidomide Celgene Norway 16.1.2013 EU/1/08/446/001-006 Privigen Iceland 22.3.2013 EU/1/08/446/001-006 Privigen Norway 21.3.2013 EU/1/08/447/001-012 Adenuric Norway 15.1.2013 EU/1/08/447/001-012 Adenuric Liechtenstein 30.4.2013 EU/1/08/447/001-012 Adenuric Iceland 14.1.2013 EU/1/08/448/001-002 Mycamine Liechtenstein 30.4.2013 EU/1/08/448/001-002 Mycamine Iceland 24.1.2013 EU/1/08/448/001-002 Mycamine Norway 12.2.2013 EU/1/08/451 Volibris Liechtenstein 30.4.2013 EU/1/08/451/001-004 Volibris Iceland 5.2.2013 EU/1/08/451/001-004 Volibris Norway 12.2.2013 EU/1/08/453 Prepandrix Liechtenstein 30.4.2013 EU/1/08/453/002 Prepandrix Iceland 6.2.2013 EU/1/08/453/002 Prepandrix Norway 4.2.2013 EU/1/08/454/001-002, 005-007 Extavia Iceland 9.1.2013 EU/1/08/454/001-002, 005-007 Extavia Liechtenstein 30.4.2013 EU/1/08/454/001-002, 005-007 Extavia Norway 10.1.2013 EU/1/08/455 Janumet Liechtenstein 30.4.2013 EU/1/08/455/001-006 Janumet Norway 10.4.2013 EU/1/08/455/001-016 Janumet Iceland 25.3.2013 EU/1/08/456 Velmetia Liechtenstein 30.4.2013 EU/1/08/456/001-016 Velmetia Iceland 26.3.2013 EU/1/08/457 Efficib Liechtenstein 30.4.2013 EU/1/08/457/001-016 Efficib Iceland 26.3.2013 EU/1/08/461 Firazyr Liechtenstein 30.4.2013 EU/1/08/461/001-002 Firazyr Iceland 11.4.2013 EU/1/08/461/001-002 Firazyr Norway 10.4.2013 EU/1/08/462 Ranexa Liechtenstein 30.4.2013 EU/1/08/462/001-002 Ranexa Norway 9.4.2013 EU/1/08/462/001-012 Ranexa Iceland 20.3.2013 EU/1/08/463 Relistor Liechtenstein 30.6.2013 EU/1/08/463/001-011 Relistor Iceland 21.6.2013 EU/1/08/463/001-011 Relistor Norway 26.6.2013 EU/1/08/465 Clopidogrel Zentiva Liechtenstein 28.2.2013 EU/1/08/465/001-021 Clopidogrel Zentiva Iceland 3.1.2013 EU/1/08/465/001-021 Clopidogrel Zentiva Norway 5.2.2013 EU/1/08/467 Doribax Liechtenstein 30.6.2013 EU/1/08/467/001-002 Doribax Iceland 17.5.2013 EU/1/08/469 Oprymea Liechtenstein 30.4.2013 EU/1/08/469/001-025 Oprymea Iceland 14.5.2013 EU/1/08/469/001-025 Oprymea Norway 24.5.2013 EU/1/08/472 Xarelto Liechtenstein 30.6.2013 EU/1/08/472/001-033 Xarelto Norway 13.6.2013 EU/1/08/472/001-033 Xarelto Iceland 20.6.2013 EU/1/08/475 Olanzapine Mylan Liechtenstein 30.6.2013 EU/1/08/475/001-060 Olanzapine Mylan Iceland 20.6.2013 EU/1/08/475/001-060 Olanzapine Mylan Norway 7.6.2013 EU/1/08/476 Adcirca Liechtenstein 30.6.2013 EU/1/08/476/005-006 Adcirca Iceland 31.5.2013 EU/1/08/476/005-006 Adcirca Norway 4.6.2013 EU/1/10/625 Arzerra Liechtenstein 30.4.2013 EU/1/10/625/001, 003 Arzerra Iceland 15.3.2013 EU/1/10/625/001, 003 Arzerra Norway 9.4.2013 EU/1/11/749 Caprelsa Liechtenstein 30.4.2013 EU/1/11/749/001-002 Caprelsa Iceland 12.3.2013 EU/1/11/749/001-002 Caprelsa Norway 9.4.2013 EU/1/12/764 Pixuvri Liechtenstein 30.4.2013 EU/1/12/764/001 Pixuvri Iceland 12.4.2013 EU/1/12/764/001 Pixuvri Norway 9.4.2013 EU/1/97/055/001-009 Viramune Liechtenstein 30.4.2013 EU/1/97/055/001-009 Viramune Iceland 14.1.2013 EU/1/97/055/001-009 Viramune Norway 22.1.2013 EU/2/02/032/001-002 Vaxxitec HVT+IBD Norway 11.6.2013 EU/2/03/037 ProteqFlu Liechtenstein 30.4.2013 EU/2/03/037/005 ProteqFlu Iceland 21.3.2013 EU/2/03/037/005 ProteqFlu Norway 20.6.2013 EU/2/03/038 ProteqFlu-Te Liechtenstein 30.4.2013 EU/2/03/038/005 ProteqFlu-Te Iceland 21.3.2013 EU/2/03/038/005 ProteqFlu-Te Norway 20.6.2013 EU/2/03/039 Advocate Liechtenstein 28.2.2013 EU/2/03/039/001-054 Advocate Iceland 19.2.2013 EU/2/03/039/001-054 Advocate Norway 5.3.2013 EU/2/07/074/001-006 Prilactone Norway 11.6.2013 EU/2/07/077/001-005 Meloxivet Norway 5.4.2013 EU/2/07/078 Rheumocam Liechtenstein 28.2.2013 EU/2/07/078/001-020 Rheumocam Iceland 11.1.2013 EU/2/07/078/001-020 Rheumocam Norway 21.1.2013 EU/2/07/079 Ingelvac CircoFLEX Liechtenstein 30.4.2013 EU/2/07/079/001-008 Ingelvac CircoFLEX Iceland 7.2.2013 EU/2/07/079/001-008 Ingelvac CircoFLEX Norway 5.3.2013 EU/2/08/081/001-003 Posatex Iceland 14.6.2013 EU/2/08/081/001-003 Posatex Norway 11.6.2013 EU/2/08/083/001-005 Equioxx Iceland 28.6.2013 EU/2/08/083/001-005 Equioxx Norway 20.6.2013

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 2013: EU-Number Product Country Date of authorisation EU/1/01/200/003-009 Viread Norway 11.1.2013 EU/1/02/221/017 Pegasys Iceland 26.3.2013 EU/1/02/221/017 Pegasys Norway 26.3.2013 EU/1/06/380/006-007 Prezista Liechtenstein 28.2.2013 EU/1/06/380/007 Prezista Iceland 6.2.2013 EU/1/06/380/007 Prezista Norway 11.2.2013 EU/1/07/433/002 Nevanac Norway 24.5.2013 EU/1/07/436/003-004 Isentress Iceland 19.3.2013 EU/1/07/436/003-004 Isentress Norway 25.2.2013 EU/1/08/468/003 Intelence Norway 17.4.2013 EU/1/09/538/009-010 Afinitor Iceland 5.2.2013 EU/1/09/538/009-010 Afinitor Norway 16.1.2013 EU/1/09/576/041-042 Irbesartan Teva Liechtenstein 28.2.2013 EU/1/11/690/003-004 Zoely Liechtenstein 28.2.2013 EU/1/11/693/017-024 Rivastigmine Actavis Iceland 17.5.2013 EU/1/11/693/017-024 Rivastigmine Actavis Norway 25.6.2013 EU/1/12/750/002 Esmya Liechtenstein 28.2.2013 EU/1/12/770/005 Docetaxel Kabi Liechtenstein 28.2.2013 EU/1/98/066/027-030 Exelon Iceland 7.2.2013 EU/1/98/066/027-030 Exelon Norway 12.2.2013 EU/1/98/077/020-023 Viagra Iceland 17.5.2013 EU/1/98/077/020-023 Viagra Norway 15.5.2013 EU/100/146/033-037 Keppra Liechtenstein 28.2.2013 EU/2/08/090/029-031 Loxicom Iceland 21.3.2013 EU/2/08/090/029-031 Loxicom Norway 6.3.2013 EU/2/10/115/016-019 Comfortis Iceland 8.2.2013 EU/2/10/115/016-019 Comfortis Norway 14.1.2013 EU/2/11/134/018-020 Inflacam Norway 17.1.2013

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 2013: EU-Number Product Country Date of withdrawal EU/1/03/266 Bondenza Liechtenstein 30.4.2013 EU/1/03/266/001-006 Bondenza Norway 12.6.2013 EU/1/07/409 Riprazo Liechtenstein 30.4.2013 EU/1/07/409/001-040 Riprazo Iceland 27.5.2013 EU/1/07/409/001-040 Riprazo Norway 14.3.2013 EU/1/08/458/001-014 Trevaclyn Iceland 15.5.2013 EU/1/08/458/001-014 Trevaclyn Norway 23.4.2013 EU/1/08/459/001-014 Tredaptive Iceland 15.5.2013 EU/1/08/459/001-014 Tredaptive Norway 23.4.2013 EU/1/08/460/001-014 Pelzont Iceland 15.5.2013 EU/1/08/460/001-014 Pelzont Norway 23.4.2013 EU/1/08/474/001-003 Alisade Iceland 27.6.2013 EU/1/09/582/001 Rilonacept Regeneron Liechtenstein 28.2.2013 EU/1/09/582/001 Rilonacept Regeneron Norway 8.2.2013 EU/1/10/656/001-006 Possia Iceland 15.4.2013 EU/1/10/656/001-006 Possia Norway 12.6.2013 EU/1/11/683/001-080 Sprimeo HCT Norway 21.3.2013 EU/1/12/754/001-021 Sepioglin Norway 20.6.2013 EU/1/97/040/001-002 Teslascan Liechtenstein 28.2.2013 EU/2/04/046 Nobivac Piro Liechtenstein 30.6.2013 EU/2/04/046/001-003 Nobivac Piro Iceland 3.6.2013 EU/2/04/046/001-003 Nobivac Piro Norway 22.5.2013