EN Official Journal of the European Union C 347/4

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2015

(2016/C 347/04)

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 January-30 June 2015, at their meeting on 29 April 2016:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 2015: EU Number Product Country Date of authorisation EU/1/07/423 Vectibix Liechtenstein 28.2.2015 EU/1/11/709 Buccolam Liechtenstein 28.2.2015 EU/1/11/721 Paglitaz Liechtenstein 28.2.2015 EU/1/11/745 Desloratadine Actavis Liechtenstein 28.2.2015 EU/1/12/755 Pioglitazone Actavis Liechtenstein 28.2.2015 EU/1/12/757 Pioglitazone Teva Liechtenstein 28.2.2015 EU/1/12/758 Pioglitazone Teva Pharma Liechtenstein 28.2.2015 EU/1/12/760 Bronchitol Liechtenstein 28.2.2015 EU/1/12/811 Lyxumia Liechtenstein 28.2.2015 EU/1/13/817 Actelsar HCT Liechtenstein 28.2.2015 EU/1/13/822 Pheburane Liechtenstein 28.2.2015 EU/1/13/830 Stribild Liechtenstein 28.2.2015 EU/1/13/835 Voriconazole Accord Liechtenstein 28.2.2015 EU/1/13/845 Imatinib Accord Liechtenstein 28.2.2015 EU/1/13/846 Xtandi Liechtenstein 28.2.2015 EU/1/13/859 Levodopa-Carbidopa-Entacapone Sandoz Liechtenstein 28.2.2015 EU/1/13/879 Giotrif Liechtenstein 28.2.2015 EU/1/13/893 Opsumit Liechtenstein 28.2.2015 EU/1/14/932 Vantobra Iceland 17.4.2015 EU/1/14/932 Vantobra Norway 15.4.2015 EU/1/14/936 Nuwiq Liechtenstein 28.2.2015 EU/1/14/952 Sevelamer carbonate Zentiva Iceland 6.2.2015 EU/1/14/952 Sevelamer carbonate Zentiva Liechtenstein 28.2.2015 EU/1/14/952 Sevelamer carbonate Zentiva Norway 6.2.2015 EU/1/14/953 Tasermity Iceland 12.3.2015 EU/1/14/953 Tasermity Liechtenstein 28.2.2015 EU/1/14/953 Tasermity Norway 12.3.2015 EU/1/14/957 Cyramza Iceland 15.1.2015 EU/1/14/957 Cyramza Liechtenstein 28.2.2015 EU/1/14/957 Cyramza Norway 13.1.2015 EU/1/14/959 Lynparza Iceland 14.1.2015 EU/1/14/959 Lynparza Norway 12.1.2015 EU/1/14/960 Duavive Iceland 14.1.2015 EU/1/14/960 Duavive Norway 12.1.2015 EU/1/14/969 Scenesse Iceland 15.1.2015 EU/1/14/969 Scenesse Norway 15.1.2015 EU/1/14/970 Rixubis Iceland 14.1.2015 EU/1/14/970 Rixubis Norway 13.1.2015 EU/1/14/972 Duloxetine Lilly Iceland 6.1.2015 EU/1/14/973 Quinsair Iceland 19.4.2015 EU/1/14/973 Quinsair Liechtenstein 30.4.2015 EU/1/14/973 Quinsair Norway 15.4.2015 EU/1/14/974 Cerdelga Iceland 5.2.2015 EU/1/14/974 Cerdelga Liechtenstein 28.2.2015 EU/1/14/974 Cerdelga Norway 10.2.2015 EU/1/14/975 Clopidogrel ratiopharm Liechtenstein 28.2.2015 EU/1/14/975 Clopidogrel ratiopharm Norway 5.3.2015 EU/1/14/975 Clopidogrel ratiopharm Iceland 11.3.2015 EU/1/14/976 Zontivity Iceland 5.2.2015 EU/1/14/976 Zontivity Liechtenstein 28.2.2015 EU/1/14/976 Zontivity Norway 16.2.2015 EU/1/14/977 Rasagilin ratiopharm Liechtenstein 28.2.2015 EU/1/14/977 Rasagiline ratiopharm Iceland 22.1.2015 EU/1/14/977 Rasagiline ratiopharm Norway 9.2.2015 EU/1/14/978 Senshio Iceland 30.1.2015 EU/1/14/978 Senshio Liechtenstein 28.2.2015 EU/1/14/978 Senshio Norway 16.2.2015 EU/1/14/979 Ofev Iceland 30.1.2015 EU/1/14/979 Ofev Liechtenstein 28.2.2015 EU/1/14/979 Ofev Norway 29.1.2015 EU/1/14/980 Cosentyx Iceland 4.2.2015 EU/1/14/980 Cosentyx Liechtenstein 28.2.2015 EU/1/14/980 Cosentyx Norway 30.1.2015 EU/1/14/981 Otezla Iceland 5.2.2015 EU/1/14/981 Otezla Liechtenstein 28.2.2015 EU/1/14/981 Otezla Norway 30.1.2015 EU/1/14/982 Viekirax Iceland 29.1.2015 EU/1/14/982 Viekirax Liechtenstein 28.2.2015 EU/1/14/982 Viekirax Norway 20.1.2015 EU/1/14/983 Exviera Iceland 29.1.2015 EU/1/14/983 Exviera Liechtenstein 28.2.2015 EU/1/14/983 Exviera Norway 20.1.2015 EU/1/14/984 Xadago Iceland 11.3.2015 EU/1/14/984 Xadago Liechtenstein 28.2.2015 EU/1/14/984 Xadago Norway 16.3.2015 EU/1/14/985 Raplixa Iceland 17.4.2015 EU/1/14/985 Raplixa Liechtenstein 30.4.2015 EU/1/14/985 Raplixa Norway 10.4.2015 EU/1/14/986 Xydalba Iceland 11.3.2015 EU/1/14/986 Xydalba Liechtenstein 28.2.2015 EU/1/14/986 Xydalba Norway 2.3.2015 EU/1/14/987 Holoclar Iceland 11.3.2015 EU/1/14/987 Holoclar Liechtenstein 28.2.2015 EU/1/14/987 Holoclar Norway 26.2.2015 EU/1/14/988 Mysimba Iceland 19.4.2015 EU/1/14/988 Mysimba Liechtenstein 30.4.2015 EU/1/14/988 Mysimba Norway 15.4.2015 EU/1/15/1000 Jinarc Iceland 4.6.2015 EU/1/15/1000 Jinarc Liechtenstein 30.6.2015 EU/1/15/1000 Jinarc Norway 12.6.2015 EU/1/15/1001 Akynzeo Iceland 4.6.2015 EU/1/15/1001 Akynzeo Liechtenstein 30.6.2015 EU/1/15/1001 Akynzeo Norway 5.6.2015 EU/1/15/1002 Lenvima Iceland 15.6.2015 EU/1/15/1002 Lenvima Liechtenstein 30.6.2015 EU/1/15/1002 Lenvima Norway 15.6.2015 EU/1/15/1003 Synjardy Iceland 9.6.2015 EU/1/15/1003 Synjardy Liechtenstein 30.6.2015 EU/1/15/1003 Synjardy Norway 17.6.2015 EU/1/15/1004 Voriconazol Hospira Liechtenstein 30.6.2015 EU/1/15/1004 Voriconazole Hospira Iceland 4.6.2015 EU/1/15/1004 Voriconazole Hospira Norway 18.6.2015 EU/1/15/1007 Gardasil 9 Liechtenstein 30.6.2015 EU/1/15/1007 Gardasil 9 Norway 18.6.2015 EU/1/15/1009 Aripiprazole Zentiva Liechtenstein 30.6.2015 EU/1/15/1010 Duloxetine Mylan Liechtenstein 30.6.2015 EU/1/15/1011 Pregabalin Sandoz Liechtenstein 30.6.2015 EU/1/15/1012 Pregabalin Sandoz GmbH Liechtenstein 30.6.2015 EU/1/15/1013 Lumark Liechtenstein 30.6.2015 EU/1/15/1014 Opdivo Liechtenstein 30.6.2015 EU/1/15/989 Orbactiv Iceland 17.4.2015 EU/1/15/989 Orbactiv Liechtenstein 30.4.2015 EU/1/15/989 Orbactiv Norway 15.4.2015 EU/1/15/990 Ikervis Iceland 17.4.2015 EU/1/15/990 Ikervis Liechtenstein 30.4.2015 EU/1/15/990 Ikervis Norway 9.4.2015 EU/1/15/991 Sivextro Iceland 19.4.2015 EU/1/15/991 Sivextro Liechtenstein 30.4.2015 EU/1/15/991 Sivextro Norway 15.4.2015 EU/1/15/992 Saxenda Iceland 19.4.2015 EU/1/15/992 Saxenda Liechtenstein 30.4.2015 EU/1/15/992 Saxenda Norway 9.4.2015 EU/1/15/993 Lixiana Liechtenstein 30.6.2015 EU/1/15/994 Kengrexal Iceland 19.4.2015 EU/1/15/994 Kengrexal Liechtenstein 30.4.2015 EU/1/15/994 Kengrexal Norway 10.4.2015 EU/1/15/995 Dutrebis Iceland 19.4.2015 EU/1/15/995 Dutrebis Liechtenstein 30.4.2015 EU/1/15/995 Dutrebis Norway 10.4.2015 EU/1/15/996 Ristempa Iceland 11.5.2015 EU/1/15/996 Ristempa Liechtenstein 30.4.2015 EU/1/15/996 Ristempa Norway 13.4.2015 EU/1/15/999 Zykadia Iceland 4.6.2015 EU/1/15/999 Zykadia Liechtenstein 30.6.2015 EU/1/15/999 Zykadia Norway 27.5.2015 EU/2/11/122 Bluevac BTV8 Liechtenstein 28.2.2015 EU/2/11/131 Zulvac 1 Ovis Liechtenstein 28.2.2015 EU/2/12/140 Poulvac E. coli Liechtenstein 28.2.2015 EU/2/12/142 Cardalis Liechtenstein 28.2.2015 EU/2/13/151 Equilis West Nile Liechtenstein 28.2.2015 EU/2/13/152 ProZinc Liechtenstein 28.2.2015 EU/2/14/162 Parvoduk Liechtenstein 28.2.2015 EU/2/14/176 Bovela Iceland 15.1.2015 EU/2/14/176 Bovela Norway 23.1.2015 EU/2/14/177 Nexgard Spectra Iceland 30.1.2015 EU/2/14/177 Nexgard Spectra Liechtenstein 28.2.2015 EU/2/14/177 Nexgard Spectra Norway 13.2.2015 EU/2/14/178 Zulvac SBV Iceland 24.2.2015 EU/2/14/178 Zulvac SBV Liechtenstein 28.2.2015 EU/2/14/178 Zulvac SBV Norway 11.3.2015 EU/2/14/179 Suvaxyn CSF Marker Iceland 9.4.2015 EU/2/14/179 Suvaxyn CSF Marker Liechtenstein 30.4.2015 EU/2/14/179 Suvaxyn CSF Marker Norway 9.4.2015 EU/2/14/180 Coliprotec F4 Iceland 15.4.2015 EU/2/14/180 Coliprotec F4 Liechtenstein 30.4.2015 EU/2/14/180 Coliprotec F4 Norway 9.4.2015 EU/2/15/181 Sileo Liechtenstein 30.6.2015 EU/2/15/181 Sileo Norway 30.6.2015

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 2015: EU Number Product Country Date of authorisation EU/1/00/133 Optisulin Iceland 18.3.2015 EU/1/00/133 Optisulin Liechtenstein 28.2.2015 EU/1/00/133 Optisulin Norway 27.2.2015 EU/1/00/134 Lantus Iceland 17.3.2015 EU/1/00/134 Lantus Liechtenstein 28.2.2015 EU/1/00/134 Lantus Norway 5.3.2015 EU/1/05/308 Aclasta Iceland 5.2.2015 EU/1/05/308 Aclasta Liechtenstein 28.2.2015 EU/1/05/308 Aclasta Norway 17.2.2015 EU/1/05/310 Fosavance Liechtenstein 30.6.2015 EU/1/05/310 Fosavance Norway 19.5.2015 EU/1/05/315 Aptivus Liechtenstein 30.6.2015 EU/1/05/319 Xolair Liechtenstein 30.6.2015 EU/1/07/423 Vectibix Iceland 15.1.2015 EU/1/07/423 Vectibix Norway 29.1.2015 EU/1/08/506 Celvapan Iceland 3.6.2015 EU/1/08/506 Celvapan Liechtenstein 30.6.2015 EU/1/08/506 Celvapan Norway 27.5.2015 EU/1/09/601 Firdapse Iceland 18.2.2015 EU/1/09/610 Telmisartan Teva Iceland 14.1.2015 EU/1/09/610 Telmisartan Teva Liechtenstein 28.2.2015 EU/1/09/610 Telmisartan Teva Norway 13.1.2015 EU/1/10/612 Revolade Iceland 30.1.2015 EU/1/10/612 Revolade Liechtenstein 28.2.2015 EU/1/10/612 Revolade Norway 29.1.2015 EU/1/10/615 Temozolomide Hospira Iceland 22.1.2015 EU/1/10/615 Temozolomide Hospira Liechtenstein 28.2.2015 EU/1/10/615 Temozolomide Hospira Norway 28.1.2015 EU/1/10/618 Prolia Iceland 4.2.2015 EU/1/10/618 Prolia Liechtenstein 28.2.2015 EU/1/10/618 Prolia Norway 9.2.2015 EU/1/10/620 Ristfor Iceland 14.1.2015 EU/1/10/620 Ristfor Norway 13.1.2015 EU/1/10/621 Ristaben Iceland 14.1.2015 EU/1/10/621 Ristaben Norway 13.1.2015 EU/1/10/625 Arzerra Iceland 2.3.2015 EU/1/10/625 Arzerra Liechtenstein 28.2.2015 EU/1/10/625 Arzerra Norway 26.2.2015 EU/1/10/627 Raloxifene Teva Iceland 20.2.2015 EU/1/10/627 Raloxifene Teva Liechtenstein 28.2.2015 EU/1/10/627 Raloxifene Teva Norway 27.2.2015 EU/1/10/631 Nivestim Iceland 15.6.2015 EU/1/10/631 Nivestim Liechtenstein 30.6.2015 EU/1/10/631 Nivestim Norway 18.6.2015 EU/1/10/632 Tolura Iceland 17.4.2015 EU/1/10/632 Tolura Liechtenstein 30.4.2015 EU/1/10/632 Tolura Norway 9.4.2015 EU/1/10/633 Topotecan Hospira Iceland 15.6.2015 EU/1/10/633 Topotecan Hospira Liechtenstein 30.6.2015 EU/1/10/633 Topotecan Hospira Norway 15.6.2015 EU/1/10/634 Ribavirin Mylan Liechtenstein 28.2.2015 EU/1/10/634 Ribavirin Mylan Norway 27.2.2015 EU/1/10/634 Ribavirin Mylan Iceland 20.2.2015 EU/1/10/635 Olanzapin Apotex Liechtenstein 28.2.2015 EU/1/10/635 Olanzapin Apotex Norway 27.2.2015 EU/1/10/635 Olanzapine Apotex Iceland 20.2.2015 EU/1/10/636 Daxas Iceland 12.5.2015 EU/1/10/636 Daxas Norway 15.5.2015 EU/1/10/637 Leflunomid medac Liechtenstein 30.4.2015 EU/1/10/637 Leflunomide medac Iceland 19.4.2015 EU/1/10/637 Leflunomide medac Norway 9.4.2015 EU/1/10/638 Ozurdex Iceland 19.4.2015 EU/1/10/638 Ozurdex Liechtenstein 30.4.2015 EU/1/10/638 Ozurdex Norway 9.4.2015 EU/1/10/639 Telmisartan Actavis Liechtenstein 30.6.2015 EU/1/10/640 Sycrest Iceland 1.6.2015 EU/1/10/640 Sycrest Liechtenstein 30.6.2015 EU/1/10/640 Sycrest Norway 3.6.2015 EU/1/10/642 Ibandronsäure Teva Liechtenstein 30.6.2015 EU/1/10/643 Rapiscan Iceland 12.5.2015 EU/1/10/643 Rapiscan Liechtenstein 30.6.2015 EU/1/10/643 Rapiscan Norway 15.6.2015 EU/1/10/646 VPRIV Liechtenstein 30.6.2015 EU/1/10/647 Myclausen Iceland 9.6.2015 EU/1/10/647 Myclausen Liechtenstein 30.6.2015 EU/1/10/647 Myclausen Norway 15.6.2015 EU/1/10/651 Clopidogrel HCS Liechtenstein 30.6.2015 EU/1/10/654 Leflunomid ratiopharm Liechtenstein 30.6.2015 EU/1/11/666 Libertek Iceland 12.5.2015 EU/1/11/666 Libertek Liechtenstein 30.6.2015 EU/1/11/666 Libertek Norway 15.5.2015 EU/1/11/668 Daliresp Iceland 12.5.2015 EU/1/11/668 Daliresp Liechtenstein 30.6.2015 EU/1/11/668 Daliresp Norway 15.5.2015 EU/1/11/749 Caprelsa Iceland 30.1.2015 EU/1/11/749 Caprelsa Liechtenstein 28.2.2015 EU/1/11/749 Caprelsa Norway 29.1.2015 EU/1/12/764 Pixuvri Iceland 19.4.2015 EU/1/12/764 Pixuvri Norway 9.4.2015 EU/1/13/818 Bosulif Iceland 11.3.2015 EU/1/13/818 Bosulif Liechtenstein 28.2.2015 EU/1/13/818 Bosulif Norway 6.3.2015 EU/1/13/848 Erivedge Iceland 5.6.2015 EU/1/13/848 Erivedge Liechtenstein 30.6.2015 EU/1/13/848 Erivedge Norway 15.6.2015 EU/1/13/875 Deltyba Iceland 12.5.2015 EU/1/13/875 Deltyba Liechtenstein 30.6.2015 EU/1/13/875 Deltyba Norway 15.5.2015 EU/1/13/890 Cometriq Iceland 5.2.2015 EU/1/13/890 Cometriq Liechtenstein 28.2.2015 EU/1/13/890 Cometriq Norway 13.2.2015 EU/1/13/901 Sirturo Iceland 5.2.2015 EU/1/13/901 Sirturo Liechtenstein 28.2.2015 EU/1/13/901 Sirturo Norway 10.2.2015 EU/2/05/055 Equilis Te Liechtenstein 30.6.2015 EU/2/05/055 Equilis Te Norway 30.6.2015 EU/2/09/103 Respiporc Flu3 Norway 16.1.2015 EU/2/09/104 Zulvac 8 Ovis Norway 14.1.2015 EU/2/10/106 Bovilis BTV8 Iceland 16.6.2015 EU/2/10/106 Bovilis BTV8 Liechtenstein 30.6.2015 EU/2/10/106 Bovilis BTV8 Norway 26.6.2015 EU/2/10/109 Rhiniseng Liechtenstein 30.6.2015

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 2015: EU Number Product Country Date of authorisation EU/1/00/133/033-035 Toujeo Iceland 12.5.2015 EU/1/00/133/033-035 Toujeo Norway 19.5.2015 EU/1/01/195/028-029 Liprolog KwikPen Iceland 19.2.2015 EU/1/04/303/004 Orfadin Iceland 3.6.2015 EU/1/04/303/004 Orfadin Norway 28.5.2015 EU/1/07/319/009 Revlimid Norway 2.3.2015 EU/1/07/391/009 Revlimid Iceland 10.3.2015 EU/1/08/469/046-049 Oprymea Iceland 2.3.2015 EU/1/08/469/050-053 Oprymea Iceland 2.3.2015 EU/1/08/469/046-049 Oprymea Norway 25.2.2015 EU/1/08/469/050-053 Oprymea Norway 25.2.2015 EU/1/12/771/007-009 Zoledronic Acid Teva Iceland 15.1.2015 EU/1/12/798/005-006 Ibandronic acid Accord Iceland 19.4.2015 EU/1/12/798/005-006 Ibandronic acid Accord Norway 10.4.2015 EU/1/13/819/002 Jetrea Iceland 13.5.2015 EU/1/13/819/002 Jetrea Norway 13.5.2015 EU/1/96/007/039-042 Humalog KwikPen Iceland 19.2.2015 EU/2/06/062/005 Cerenia Norway 29.6.2015 EU/2/07/078/021 Rheumocam Iceland 4.6.2015 EU/2/07/078/021 Rheumocam Norway 2.6.2015 EU/2/97/004/050-053 Metacam Norway 6.5.2015 EU/2/97/004/050-053 Metacam Iceland 6.5.2015 EU/2/99/014/013-016 Stronghold Norway 10.4.2015

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 2015: EU Number Product Country Date of authorisation EU/1/07/426 Olanzapine Cipla Norway 21.1.2015 EU/1/08/458 Trevaclyn Liechtenstein 28.2.2015 EU/1/08/459 Tredaptive Liechtenstein 28.2.2015 EU/1/08/460 Pelzont Liechtenstein 28.2.2015 EU/1/09/554 Clopidogrel ratiopharm Liechtenstein 28.2.2015 EU/1/09/560 Clopidogrel Dura Liechtenstein 30.6.2015 EU/1/09/560 Clopidogrel Dura Norway 30.6.2015 EU/1/10/649 Clopidogrel Teva Pharma B.V. Norway 21.1.2015 EU/1/10/650 Clopidogrel Teva Generics B.V. Iceland 5.2.2015 EU/1/10/664 Pumarix Iceland 20.2.2015 EU/1/10/664 Pumarix Liechtenstein 28.2.2015 EU/1/10/664 Pumarix Norway 31.1.2015 EU/1/11/686 Rasilamlo Liechtenstein 30.6.2015 EU/1/11/723 Pioglitazone Krka Norway 21.1.2015 EU/1/11/748 Docetaxel Mylan (Sunset clause) Norway 3.2.2015 EU/1/12/754 Sepioglin Liechtenstein 28.2.2015 EU/1/12/774 Rienso Iceland 12.5.2015 EU/1/12/774 Rienso Liechtenstein 30.4.2015 EU/1/12/774 Rienso Norway 19.5.2015 EU/1/12/804 BindRen Iceland 13.3.2015 EU/1/12/804 BindRen Liechtenstein 30.4.2015 EU/1/12/804 BindRen Norway 14.4.2015 EU/1/13/867 Provenge Liechtenstein 30.6.2015 EU/1/13/867 Provenge Norway 15.6.2015 EU/1/97/037 Vistide Norway 4.2.2015 EU/2/04/049 Purevax RCCh Iceland 10.2.2015 EU/2/07/071 Slentrol Iceland 5.2.2015 EU/2/07/071 Slentrol Liechtenstein 28.2.2015 EU/2/07/071 Slentrol Norway 30.3.2015 EU/2/11/136 TruScient Iceland 5.2.2015 EU/2/11/136 TruScient Liechtenstein 28.2.2015 EU/2/11/136 TruScient Norway 22.4.2015