EN Official Journal of the European Union C 391/15

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

2014/C 391/04

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 July-31 December 2013, at their meeting on 16 May 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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 July-31 December 2013: EU-Number Product Country Date of authorisation EU/1/13/818/001-004 Bosulif Liechtenstein 31.8.2013 EU/1/13/820 Marixino Iceland 22.8.2013 EU/1/13/822 PHEBURANE Iceland 21.8.2013 EU/1/13/822 PHEBURANE Norway 29.8.2013 EU/1/13/830 Stribild Norway 1.7.2013 EU/1/13/831 Capecitabin SUN Liechtenstein 31.8.2013 EU/1/13/831 Capecitabine SUN Iceland 19.7.2013 EU/1/13/831 Capecitabine SUN Norway 26.7.2013 EU/1/13/832 Stayveer Liechtenstein 31.8.2013 EU/1/13/832 Stayveer Iceland 19.7.2013 EU/1/13/832 Stayveer Norway 24.7.2013 EU/1/13/833 Nuedexta Liechtenstein 31.8.2013 EU/1/13/833 NUEDEXTA Iceland 24.7.2013 EU/1/13/833 Nuedexta Norway 3.7.2013 EU/1/13/836 Memantine ratiopharm Iceland 9.8.2013 EU/1/13/838 AUBAGIO Liechtenstein 31.10.2013 EU/1/13/838 AUBAGIO Iceland 9.9.2013 EU/1/13/838 AUBAGIO Norway 18.9.2013 EU/1/13/839 Iclusig Liechtenstein 31.10.2013 EU/1/13/839 Iclusig Iceland 19.7.2013 EU/1/13/839 Iclusig Norway 23.7.2013 EU/1/13/840 HyQvia Liechtenstein 31.10.2013 EU/1/13/841 Spedra Liechtenstein 31.8.2013 EU/1/13/841 Spedra Iceland 19.7.2013 EU/1/13/841 Spedra Norway 19.7.2013 EU/1/13/842 Incresync Liechtenstein 31.10.2013 EU/1/13/842 Incresync Iceland 14.10.2013 EU/1/13/842 Incresync Norway 10.10.2013 EU/1/13/843 Vipdomet Liechtenstein 31.10.2013 EU/1/13/843 Vipdomet Iceland 15.10.2013 EU/1/13/843 Vipdomet Norway 10.10.2013 EU/1/13/844 Vipidia Liechtenstein 31.10.2013 EU/1/13/844 Vipidia Iceland 15.10.2013 EU/1/13/844 Vipidia Norway 10.10.2013 EU/1/13/845 Imatinib Accord Iceland 18.7.2013 EU/1/13/845 Imatinib Accord Norway 18.7.2013 EU/1/13/846 Xtandi Iceland 19.7.2013 EU/1/13/846 Xtandi Norway 17.7.2013 EU/1/13/847 MACI Liechtenstein 31.8.2013 EU/1/13/847 MACI Iceland 24.7.2013 EU/1/13/847 MACI Norway 17.7.2013 EU/1/13/848 Erivedge Liechtenstein 31.8.2013 EU/1/13/848 Erivedge Iceland 8.8.2013 EU/1/13/848 Erivedge Norway 13.8.2013 EU/1/13/849 Somatropin Biopartners Liechtenstein 31.8.2013 EU/1/13/849 Somatropin Biopartners Iceland 22.8.2013 EU/1/13/849 Somatropin Biopartners Norway 10.9.2013 EU/1/13/850 Pomalidomide Celgene Iceland 23.8.2013 EU/1/13/850 Pomalidomide Celgene Liechtenstein 31.10.2013 EU/1/13/850 Pomalidomide Celgene Norway 15.8.2013 EU/1/13/851 Lojuxta Liechtenstein 31.8.2013 EU/1/13/851 Lojuxta Iceland 21.8.2013 EU/1/13/851 Lojuxta Norway 28.8.2013 EU/1/13/852 Atosiban SUN Liechtenstein 31.8.2013 EU/1/13/852 Atosiban SUN Iceland 20.8.2013 EU/1/13/852 Atosiban SUN Norway 29.8.2013 EU/1/13/853 Remsima Liechtenstein 31.10.2013 EU/1/13/853 Remsima Iceland 20.9.2013 EU/1/13/853 Remsima Norway 17.9.2013 EU/1/13/854 Inflectra Liechtenstein 31.10.2013 EU/1/13/854 Inflectra Iceland 20.9.2013 EU/1/13/854 Inflectra Norway 10.10.2013 EU/1/13/855 Imvanex Liechtenstein 31.8.2013 EU/1/13/855 IMVANEX Iceland 23.8.2013 EU/1/13/855 Imvanex Norway 17.9.2013 EU/1/13/856 Lonquex Iceland 20.8.2013 EU/1/13/856 Lonquex Norway 23.8.2013 EU/1/13/857 Voncento Liechtenstein 31.10.2013 EU/1/13/857 Voncento Iceland 11.10.2013 EU/1/13/857 Voncento Norway 16.9.2013 EU/1/13/858 Stivarga Liechtenstein 31.10.2013 EU/1/13/858 Stivarga Iceland 19.9.2013 EU/1/13/858 Stivarga Norway 9.9.2013 EU/1/13/859 Levodopa/Carbidopa/Entacapone Sandoz Iceland 22.11.2013 EU/1/13/859 Levodopa/Carbidopa/Entacapone Sandoz Norway 10.12.2013 EU/1/13/860 Nexium Control Liechtenstein 31.10.2013 EU/1/13/860 Nexium Control Iceland 9.9.2013 EU/1/13/860 Nexium Control Norway 6.9.2013 EU/1/13/861 Procysbi Liechtenstein 31.10.2013 EU/1/13/861 Procysbi Iceland 23.9.2013 EU/1/13/861 Procysbi Norway 24.9.2013 EU/1/13/862 Ultibro Breezhaler Liechtenstein 31.10.2013 EU/1/13/862 Ultibro Breezhaler Iceland 15.10.2013 EU/1/13/862 Ultibro Breezhaler Norway 18.10.2013 EU/1/13/863 Xoterna Breezhaler Liechtenstein 31.10.2013 EU/1/13/863 Xoterna Breezhaler Iceland 14.10.2013 EU/1/13/863 Xoterna Breezhaler Norway 18.10.2013 EU/1/13/865 Tafinlar Liechtenstein 31.10.2013 EU/1/13/865 Tafinlar Iceland 19.9.2013 EU/1/13/865 Tafinlar Norway 18.9.2013 EU/1/13/866 Cholib Liechtenstein 31.10.2013 EU/1/13/866 Cholib Iceland 19.9.2013 EU/1/13/866 Cholib Norway 24.9.2013 EU/1/13/867 Provenge Liechtenstein 31.10.2013 EU/1/13/867 Provenge Iceland 19.9.2013 EU/1/13/867 Provenge Norway 24.9.2013 EU/1/13/868 EVARREST Liechtenstein 31.10.2013 EU/1/13/868 EVARREST Iceland 21.10.2013 EU/1/13/868 Evarrest Norway 18.10.2013 EU/1/13/869 Lemtrada Liechtenstein 31.10.2013 EU/1/13/869 Lemtrada Iceland 23.9.2013 EU/1/13/869 Lemtrada Norway 10.10.2013 EU/1/13/870 Orphacol Liechtenstein 31.10.2013 EU/1/13/870 Orphacol Iceland 10.10.2013 EU/1/13/870 Orphacol Norway 25.9.2013 EU/1/13/871 Ovaleap Liechtenstein 31.10.2013 EU/1/13/871 Ovaleap Iceland 22.10.2013 EU/1/13/871 Ovaleap Norway 17.10.2013 EU/1/13/872 Tybost Liechtenstein 31.10.2013 EU/1/13/872 Tybost Iceland 11.10.2013 EU/1/13/872 Tybost Norway 17.10.2013 EU/1/13/873 Xofigo Liechtenstein 31.12.2013 EU/1/13/873 Xofigo Iceland 11.12.2013 EU/1/13/873 Xofigo Norway 9.12.2013 EU/1/13/876 Imatinib Medac Liechtenstein 31.10.2013 EU/1/13/876 Imatinib medac Iceland 17.10.2013 EU/1/13/876 Imatinib medac Norway 16.10.2013 EU/1/13/877 Grastofil Liechtenstein 31.10.2013 EU/1/13/877 Grastofil Iceland 12.11.2013 EU/1/13/877 Grastofil Norway 18.11.2013 EU/1/13/878 Defitelio Liechtenstein 31.10.2013 EU/1/13/878 Defitelio Iceland 12.11.2013 EU/1/13/878 Defitelio Norway 21.11.2013 EU/1/13/879 Giotrif Iceland 18.10.2013 EU/1/13/879 Giotrif Norway 16.10.2013 EU/1/13/880 Memantine Accord Iceland 16.12.2013 EU/1/13/880 Memantine Accord Norway 17.12.2013 EU/1/13/880 Memantin Accord Liechtenstein 31.12.2013 EU/1/13/881 Lidocaine/Prilocaine Plethora Liechtenstein 31.12.2013 EU/1/13/881 Lidocaine/Prilocaine Plethora Iceland 12.12.2013 EU/1/13/881 Lidocaine/Prilocaine Plethora Norway 16.12.2013 EU/1/13/882 ABILIFY MAINTENA Liechtenstein 31.12.2013 EU/1/13/882 ABILIFY MAINTENA Iceland 12.12.2013 EU/1/13/882 Abilify Maintena Norway 16.12.2013 EU/1/13/883 Vitekta Liechtenstein 31.12.2013 EU/1/13/883 Vitekta Iceland 11.12.2013 EU/1/13/883 Vitekta Norway 16.12.2013 EU/1/13/884 Invokana Liechtenstein 31.12.2013 EU/1/13/884 Invokana Iceland 12.12.2013 EU/1/13/884 Invokana Norway 16.12.2013 EU/1/13/885 Kadcyla Liechtenstein 31.12.2013 EU/1/13/885 Kadcyla Iceland 12.12.2013 EU/1/13/885 Kadcyla Norway 16.12.2013 EU/1/13/886 Relvar Ellipta Iceland 11.12.2013 EU/1/13/886 Relvar Ellipta Liechtenstein 31.12.2013 EU/1/13/886 Relvar Ellipta Norway 25.11.2013 EU/1/13/887 Fluenz Tetra Norway 4.12.2013 EU/1/13/888 NovoEight Liechtenstein 31.12.2013 EU/1/13/888 NovoEight Iceland 11.12.2013 EU/1/13/888 NovoEight Norway 16.12.2013 EU/1/13/893 Opsumit Norway 20.12.2013 EU/2/13/148 Meloxidolor Norway 6.8.2013 EU/2/13/150 Oncept IL-2 Iceland 18.7.2013 EU/2/13/152 ProZinc Iceland 8.8.2013 EU/2/13/152 ProZinc Norway 5.8.2013 EU/2/13/153 Aftovaxpur Doe Liechtenstein 31.8.2013 EU/2/13/153 Aftovaxpur Doe Iceland 9.8.2013 EU/2/13/153 Aftovaxpur Doe Norway 15.7.2013 EU/2/13/154 Apoquel Liechtenstein 31.10.2013 EU/2/13/154 Apoquel Iceland 20.9.2013 EU/2/13/154 Apoquel Norway 12.9.2013 EU/2/13/155 Trifexis Liechtenstein 31.10.2013 EU/2/13/155 Trifexis Iceland 14.10.2013 EU/2/13/156 Vectra 3D Liechtenstein 31.12.2013 EU/2/13/156 Vectra 3D Iceland 23.12.2013 EU/2/13/157 BROADLINE Liechtenstein 31.12.2013 EU/2/13/157 BROADLINE Iceland 23.12.2013

ANNEX II List of renewed marketing authorisations The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July-31 December 2013: EU-Number Product Country Date of authorisation EU/1/03/255 Ventavis Liechtenstein 31.10.2013 EU/1/03/255 Ventavis Iceland 9.9.2013 EU/1/03/255 Ventavis Norway 18.9.2013 EU/1/06/380 Prezista Iceland 11.10.2013 EU/1/06/380 Prezista Norway 18.10.2013 EU/1/07/440 Tyverb Iceland 26.8.2013 EU/1/08/444 Ratiograstim Liechtenstein 31.8.2013 EU/1/08/444 Ratiograstim Iceland 19.8.2013 EU/1/08/444 Ratiograstim Norway 15.8.2013 EU/1/08/445 Tevagrastim Liechtenstein 31.8.2013 EU/1/08/445 Tevagrastim Iceland 19.8.2013 EU/1/08/445 Tevagrastim Norway 15.8.2013 EU/1/08/450 Biograstim Liechtenstein 31.8.2013 EU/1/08/450 Biograstim Iceland 20.8.2013 EU/1/08/450 Biograstim Norway 27.8.2013 EU/1/08/456 Velmetia Norway 11.9.2013 EU/1/08/457 Efficib Norway 11.9.2013 EU/1/08/466 Bridion Liechtenstein 31.8.2013 EU/1/08/466 Bridion Iceland 17.7.2013 EU/1/08/466 Bridion Norway 19.7.2013 EU/1/08/467 Doribax Norway 29.7.2013 EU/1/08/468 INTELENCE Iceland 17.7.2013 EU/1/08/468 Intelence Norway 24.7.2013 EU/1/08/470 Vimpat Liechtenstein 31.8.2013 EU/1/08/470 Vimpat Iceland 21.8.2013 EU/1/08/470 Vimpat Norway 13.8.2013 EU/1/08/473 Evicel Liechtenstein 31.12.2013 EU/1/08/473 Evicel Iceland 16.12.2013 EU/1/08/473 Evicel Norway 18.12.2013 EU/1/08/477 Ceplene Liechtenstein 31.10.2013 EU/1/08/477 Ceplene Iceland 11.9.2013 EU/1/08/477 Ceplene Norway 18.9.2013 EU/1/08/479 Zypadhera Iceland 9.9.2013 EU/1/08/479 Zypadhera Norway 9.9.2013 EU/1/08/480 Ifirmasta Liechtenstein 31.8.2013 EU/1/08/480 Ifirmasta Iceland 9.9.2013 EU/1/08/480 Ifirmasta Norway 11.9.2013 EU/1/08/481 Kuvan Liechtenstein 31.12.2013 EU/1/08/481 Kuvan Iceland 11.12.2013 EU/1/08/481 Kuvan Norway 10.12.2013 EU/1/08/482 Azarga Iceland 5.9.2013 EU/1/08/482 Azarga Norway 18.9.2013 EU/1/08/483 Zomarist Iceland 21.8.2013 EU/1/08/483 Zomarist Norway 5.9.2013 EU/1/08/484 Icandra Iceland 21.8.2013 EU/1/08/484 Icandra Norway 5.9.2013 EU/1/08/485 Jalra Liechtenstein 31.12.2013 EU/1/08/485 Jalra Iceland 16.12.2013 EU/1/08/485 Jalra Norway 16.12.2013 EU/1/08/486 Xiliarx Liechtenstein 31.12.2013 EU/1/08/486 Xiliarx Iceland 16.12.2013 EU/1/08/486 Xiliarx Norway 16.12.2013 EU/1/08/488 Vidaza Liechtenstein 31.12.2013 EU/1/08/488 Vidaza Iceland 10.12.2013 EU/1/08/488 Vidaza Norway 16.12.2013 EU/1/08/489 Opgenra Liechtenstein 31.12.2013 EU/1/08/489 Opgenra Iceland 16.12.2013 EU/1/08/489 Opgenra Norway 16.12.2013 EU/1/08/490 Pramipexole Teva Iceland 23.9.2013 EU/1/08/490 Pramipexole Teva Norway 20.9.2013 EU/1/08/491 Rasilez HCT Liechtenstein 31.12.2013 EU/1/08/491 Rasilez HCT Iceland 25.11.2013 EU/1/08/491 Rasilez HCT Norway 18.12.2013 EU/1/08/492 RoActemra Iceland 17.10.2013 EU/1/08/492 RoActemra Norway 16.10.2013 EU/1/08/494 Stelara Liechtenstein 31.10.2013 EU/1/08/494 Stelara Iceland 14.10.2013 EU/1/08/494 Stelara Norway 2.10.2013 EU/1/08/495 Zarzio Liechtenstein 31.12.2013 EU/1/08/495 Zarzio Iceland 26.11.2013 EU/1/08/495 Zarzio Norway 16.12.2013 EU/1/08/496 Filgrastim Hexal Liechtenstein 31.12.2013 EU/1/08/496 Filgrastim Hexal Iceland 25.11.2013 EU/1/08/496 Filgrastim Hexal Norway 16.12.2013 EU/1/08/498 Thymanax Liechtenstein 31.12.2013 EU/1/08/498 Thymanax Iceland 25.11.2013 EU/1/08/498 Thymanax Norway 16.12.2013 EU/1/08/499 Valdoxan Iceland 25.11.2013 EU/1/08/499 Valdoxan Norway 17.12.2013 EU/1/08/503 Efient Liechtenstein 31.12.2013 EU/1/08/503 Efient Iceland 10.12.2013 EU/1/08/503 Efient Norway 18.12.2013 EU/1/08/504 Firmagon Iceland 10.12.2013 EU/1/08/504 Firmagon Norway 16.12.2013 EU/1/08/505 Intanza Iceland 17.10.2013 EU/1/08/505 Intanza Norway 22.10.2013 EU/1/08/507 IDflu Iceland 17.10.2013 EU/1/08/507 IDflu Norway 22.10.2013 EU/1/10/628 Votrient Iceland 1.8.2013 EU/1/10/628 Votrient Norway 13.8.2013 EU/1/11/699 Fampyra Iceland 17.7.2013 EU/1/11/699 Fampyra Norway 12.8.2013 EU/1/11/710 Votubia Liechtenstein 31.8.2013 EU/1/11/710 Votubia Iceland 9.8.2013 EU/1/11/710 Votubia Norway 13.8.2013 EU/1/12/793 Xalkori Iceland 10.9.2013 EU/1/12/793 Xalkori Norway 26.8.2013 EU/1/12/794 Adcetris Iceland 9.9.2013 EU/1/12/794 Adcetris Norway 23.9.2013 EU/1/99/103 ReFacto AF Liechtenstein 31.12.2013 EU/1/99/103 Refacto AF Norway 18.12.2013 EU/2/07/075 Circovac Norway 9.8.2013 EU/2/08/080 Reconcile Liechtenstein 31.8.2013 EU/2/08/080 Reconcile Iceland 8.8.2013 EU/2/08/082 Zactran Liechtenstein 31.8.2013 EU/2/08/082 Zactran Iceland 9.8.2013 EU/2/08/082 Zactran Norway 12.8.2013 EU/2/08/084 Trocoxil Iceland 4.9.2013 EU/2/08/086 Equip WNV Liechtenstein 31.10.2013 EU/2/08/086 Equip WNV Iceland 24.9.2013 EU/2/08/087 Masivet Liechtenstein 31.10.2013 EU/2/08/087 Masivet Iceland 17.10.2013 EU/2/08/089 Onsior Iceland 22.11.2013 EU/2/08/091 Porcilis PCV Liechtenstein 31.12.2013

ANNEX III List of extended marketing authorisations The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July-31 December 2013: EU-Number Product Country Date of authorisation EU/1/00/145/002 Herceptin Norway 6.9.2013 EU/1/00/145/002 Herceptin Iceland 9.9.2013 EU/1/02/203/005-007 Kineret Norway 13.12.2013 EU/1/02/203/005-007 Kineret Iceland 13.12.2013 EU/1/03/249/016 Vivanza Norway 5.8.2013 EU/1/03/249/016 Vivanza Iceland 17.7.2013 EU/1/07/436/003-004 Isentress Norway 4.7.2013 EU/1/08/469/026-045 Oprymea Norway 25.11.2013 EU/1/08/469/026-045 Oprymea Iceland 22.11.2013 EU/1/09/546/005-008 Simponi Norway 7.10.2013 EU/1/09/546/005-008 Simponi Iceland 12.9.2013 EU/1/10/612/007-009 Revolade Norway 10.10.2013 EU/1/10/612/007-009 Revolade Iceland 11.10.2013 EU/1/10/637/010-013 Leflunomide medac Norway 27.8.2013 EU/1/10/637/010-013 Leflunomide medac Iceland 19.8.2013 EU/1/11/706/034-038 Levodopa/Carbidopa/Entacapone Orion Norway 18.10.2013 EU/1/11/706/034-038 Levodopa/Carbidopa/Entacapone Orion Iceland 18.7.2013 EU/1/11/710/009-015 Votubia Norway 13.12.2013 EU/1/12/777/007-012 Inlyta Norway 18.9.2013 EU/1/12/777/007-012 Inlyta Iceland 4.9.2013 EU/1/97/030/202-203 Insuman Implantable Norway 18.10.2013 EU/2/04/044/015-016 Aivlosin Iceland 23.12.2013 EU/2/08/090/029-031 Loxicom Norway 26.9.2013 EU/2/09/098/002-007 Melovem Iceland 21.10.2013 EU/2/10/115/011-019 Comfortis Norway 6.8.2013 EU/2/10/115/020-021 Comfortis Iceland 11.12.2013

ANNEX IV List of withdrawn marketing authorisations The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2013: EU-Number Product Country Date of withdrawal EU/1/01/189 Replagal Norway 14.8.2013 EU/1/03/266 Bondenza Iceland 12.11.2013 EU/1/09/554 Clopidogrel ratiopharm Norway 25.11.2013 EU/1/10/656 Possia Liechtenstein 31.8.2013 EU/1/11/687 Hizentra Norway 14.8.2013 EU/1/11/730 Rasitrio Iceland 20.9.2013 EU/1/11/730 Rasitrio Norway 3.9.2013 EU/1/12/754 Sepioglin Iceland 12.11.2013 EU/2/00/022 Ibaflin Liechtenstein 31.8.2013 EU/2/09/093 Netvax Liechtenstein 31.10.2013 EU/2/09/093 Netvax Iceland 16.10.2013 EU/2/09/093 Netvax Norway 19.9.2013 EU/2/98/010 Econor Norway 5.8.2013