EN Official Journal of the European Union C 195/26

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016

(2018/C 195/11)

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 2016, at their meeting on 17 March 2017:

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Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations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 2016: EU Number Product Country Date of authorisation EU/1/12/793 Xalkori (Switch to non-conditional) Liechtenstein 31.12.2016 EU/1/13/848 Erivedge (Switch to non-conditional) Liechtenstein 31.12.2016 EU/1/15/1066 Ongentys Iceland 13.7.2016 EU/1/15/1066 Ongentys Norway 4.7.2016 EU/1/16/1091 Atazanavir Mylan Iceland 29.8.2016 EU/1/16/1091 Atazanavir Mylan Norway 2.9.2016 EU/1/16/1091 Atazanavir Mylan Liechtenstein 31.8.2016 EU/1/16/1094 Ninlaro Liechtenstein 31.12.2016 EU/1/16/1094 Ninlaro Iceland 7.12.2016 EU/1/16/1094 Ninlaro Norway 28.11.2016 EU/1/16/1102 Bortezomib SUN Iceland 11.8.2016 EU/1/16/1102 Bortezomib SUN Norway 12.8.2016 EU/1/16/1102 Bortezomib SUN Liechtenstein 31.8.2016 EU/1/16/1103 Neparvis Iceland 4.7.2016 EU/1/16/1105 EndolucinBeta Iceland 25.7.2016 EU/1/16/1105 EndolucinBeta Norway 27.7.2016 EU/1/16/1105 EndolucinBeta Liechtenstein 31.8.2016 EU/1/16/1107 ZINBRYTA Iceland 14.7.2016 EU/1/16/1107 Zinbryta Norway 7.7.2016 EU/1/16/1107 Zinbryta Liechtenstein 31.8.2016 EU/1/16/1108 Qtern Iceland 25.7.2016 EU/1/16/1108 Qtern Norway 4.8.2016 EU/1/16/1108 Qtern Liechtenstein 31.8.2016 EU/1/16/1109 ZAVICEFTA Iceland 12.7.2016 EU/1/16/1109 Zavicefta Norway 1.7.2016 EU/1/16/1112 Odefsey Iceland 12.7.2016 EU/1/16/1113 Enzepi Iceland 14.7.2016 EU/1/16/1113 Enzepi Norway 26.7.2016 EU/1/16/1113 Enzepi Liechtenstein 31.8.2016 EU/1/16/1114 Bortezomib Hospira Iceland 10.8.2016 EU/1/16/1114 Bortezomib Hospira Norway 12.8.2016 EU/1/16/1114 Bortezomib Hospira Liechtenstein 31.8.2016 EU/1/16/1115 Pemetrexed Fresenius Kabi Iceland 16.8.2016 EU/1/16/1115 Pemetrexed Fresenius Kabi Norway 11.8.2016 EU/1/16/1116 Epclusa Iceland 12.7.2016 EU/1/16/1116 Epclusa Norway 11.7.2016 EU/1/16/1116 Epclusa Liechtenstein 31.8.2016 EU/1/16/1119 Zepatier Iceland 11.8.2016 EU/1/16/1119 Zepatier Norway 4.8.2016 EU/1/16/1119 Zepatier Liechtenstein 31.8.2016 EU/1/16/1121 Zalmoxis Iceland 7.9.2016 EU/1/16/1121 Zalmoxis Norway 16.9.2016 EU/1/16/1121 Zalmoxis Liechtenstein 31.10.2016 EU/1/16/1122 Aerivio Spiromax Iceland 2.9.2016 EU/1/16/1122 Aerivio Spiromax Norway 8.9.2016 EU/1/16/1122 Aerivio Spiromax Liechtenstein 31.10.2016 EU/1/16/1123 Airexar Spiromax Iceland 2.9.2016 EU/1/16/1123 Airexar Spiromax Norway 13.9.2016 EU/1/16/1123 Airexar Spiromax Liechtenstein 31.10.2016 EU/1/16/1124 Nordimet Iceland 7.9.2016 EU/1/16/1124 Nordimet Norway 30.8.2016 EU/1/16/1124 Nordimet Liechtenstein 31.8.2016 EU/1/16/1125 Cinqaero Iceland 7.9.2016 EU/1/16/1125 Cinqaero Norway 31.8.2016 EU/1/16/1125 Cinqaero Liechtenstein 31.8.2016 EU/1/16/1126 Truberzi Iceland 7.10.2016 EU/1/16/1126 Truberzi Norway 6.10.2016 EU/1/16/1126 Truberzi Liechtenstein 31.10.2016 EU/1/16/1127 Tenofovir disoproxil Zentiva Iceland 6.10.2016 EU/1/16/1127 Tenofovir disoproxil Zentiva Liechtenstein 31.10.2016 EU/1/16/1127 Tenofovir disoproxil Zentiva Norway 13.10.2016 EU/1/16/1128 Kisplyx Iceland 7.9.2016 EU/1/16/1128 Kisplyx Norway 31.8.2016 EU/1/16/1128 Kisplyx Liechtenstein 31.8.2016 EU/1/16/1129 Tenofovir disoproxil Mylan Iceland 16.12.2016 EU/1/16/1129 Tenofovir disoproxil Mylan Norway 21.12.2016 EU/1/16/1130 Onivyde Iceland 1.11.2016 EU/1/16/1130 Onivyde Norway 4.11.2016 EU/1/16/1130 Onivyde Liechtenstein 31.10.2016 EU/1/16/1131 Thorinane Iceland 6.10.2016 EU/1/16/1131 Thorinane Norway 23.9.2016 EU/1/16/1131 Thorinane Liechtenstein 31.10.2016 EU/1/16/1132 Inhixa Iceland 7.10.2016 EU/1/16/1132 Inhixa Norway 5.10.2016 EU/1/16/1132 Inhixa Liechtenstein 31.10.2016 EU/1/16/1134 Mysildecard Iceland 6.10.2016 EU/1/16/1134 Mysildecard Norway 29.9.2016 EU/1/16/1134 Mysildecard Liechtenstein 31.10.2016 EU/1/16/1135 Sialanar Iceland 7.10.2016 EU/1/16/1135 Sialanar Norway 14.10.2016 EU/1/16/1135 Sialanar Liechtenstein 31.10.2016 EU/1/16/1136 Cabometyx Iceland 6.10.2016 EU/1/16/1136 CABOMETYX Norway 20.9.2016 EU/1/16/1136 CABOMETYX Liechtenstein 31.10.2016 EU/1/16/1137 Granpidam Liechtenstein 31.12.2016 EU/1/16/1137 Granpidam Iceland 6.12.2016 EU/1/16/1137 Granpidam Norway 28.11.2016 EU/1/16/1138 Venclyxto Iceland 8.12.2016 EU/1/16/1138 Venclyxto Norway 13.12.2016 EU/1/16/1139 Ocaliva Iceland 19.12.2016 EU/1/16/1139 OCALIVA Norway 12.12.2016 EU/1/16/1141 SomaKit TOC Iceland 15.12.2016 EU/1/16/1141 SomaKit TOC Norway 15.12.2016 EU/1/16/1142 Parsabiv Liechtenstein 31.12.2016 EU/1/16/1142 Parsabiv Iceland 1.12.2016 EU/1/16/1142 Parsabiv Norway 22.11.2016 EU/1/16/1143 Lartruvo Liechtenstein 31.12.2016 EU/1/16/1143 Lartruvo Iceland 1.12.2016 EU/1/16/1143 Lartruvo Norway 18.11.2016 EU/1/16/1144 Ivabradine Zentiva Liechtenstein 31.12.2016 EU/1/16/1144 Ivabradine Zentiva Iceland 2.12.2016 EU/1/16/1144 Ivabradine Zentiva Norway 28.11.2016 EU/1/16/1145 Ivabradine JensonR Liechtenstein 31.12.2016 EU/1/16/1145 Ivabradine JensonR Iceland 2.12.2016 EU/1/16/1145 Ivabradine JensonR Norway 5.12.2016 EU/1/16/1146 Glyxambi Liechtenstein 31.12.2016 EU/1/16/1146 Glyxambi Iceland 5.12.2016 EU/1/16/1146 Glyxambi Norway 9.12.2016 EU/1/16/1147 IBRANCE Liechtenstein 31.12.2016 EU/1/16/1147 Ibrance Iceland 1.12.2016 EU/1/16/1147 IBRANCE Norway 15.11.2016 EU/1/16/1148 Emtricitabin/Tenofovir disoproxil Zentiva Liechtenstein 31.12.2016 EU/1/16/1148 Emtricitabine/Tenofovir disoproxil Zentiva Iceland 1.12.2016 EU/1/16/1148 Emtricitabine/Tenofovir disoproxil Zentvia Norway 15.11.2016 EU/1/16/1151 Emtricitabine/Tenofovir disproxil Krka Norway 21.12.2016 EU/1/16/1151 Emtricitabine/Tenofovir disoproxil Krka Iceland 14.12.2016 EU/2/16/196 Sevocalm Norway 11.7.2016 EU/2/16/196 Sevocalm Liechtenstein 31.8.2016 EU/2/16/196 Sevocalm Iceland 12.7.2016 EU/2/16/198 Sedadex Iceland 22.8.2016 EU/2/16/198 Sedadex Norway 30.8.2016 EU/2/16/198 Sedadex Liechtenstein 31.8.2016 EU/2/16/199 Eravac Iceland 10.10.2016 EU/2/16/199 ERAVAC Norway 5.10.2016 EU/2/16/199 ERAVAC Liechtenstein 31.10.2016 EU/2/16/200 Cepedex Iceland 19.12.2016

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 2016: EU Number Product Country Date of authorisation EU/1/06/347 Sutent Liechtenstein 31.12.2016 EU/1/06/347 Sutent Iceland 1.12.2016 EU/1/06/347 Sutent Norway 15.11.2016 EU/1/06/355 ATryn Iceland 26.7.2016 EU/1/06/355 ATryn Norway 10.8.2016 EU/1/06/355 ATryn Liechtenstein 31.8.2016 EU/1/06/360 Champix Iceland 13.7.2016 EU/1/06/360 Champix Norway 7.7.2016 EU/1/06/360 Champix Liechtenstein 31.8.2016 EU/1/06/361 Luminity Iceland 26.7.2016 EU/1/06/361 Luminity Norway 6.8.2016 EU/1/06/361 Luminity Liechtenstein 31.8.2016 EU/1/06/362 Byetta Iceland 18.8.2016 EU/1/06/363 Sprycel Iceland 18.8.2016 EU/1/06/363 Sprycel Norway 12.8.2016 EU/1/06/363 Sprycel Liechtenstein 31.8.2016 EU/1/06/364 Adrovance Iceland 16.10.2016 EU/1/06/365 Elaprase Iceland 16.10.2016 EU/1/06/366 Tandemact Iceland 16.10.2016 EU/1/06/374 Lucentis Liechtenstein 31.12.2016 EU/1/06/374 Lucentis Iceland 2.12.2016 EU/1/06/374 Lucentis Norway 22.11.2016 EU/1/06/379 Cystadane Iceland 7.12.2016 EU/1/06/379 Cystadane Norway 29.11.2016 EU/1/11/699 Fampyra Norway 8.7.2016 EU/1/11/701 Levatiracetam Teva Norway 4.8.2016 EU/1/11/701 Levetiracetam Teva Iceland 26.7.2016 EU/1/11/701 Levetiracetam Teva Liechtenstein 31.8.2016 EU/1/11/706 Levodopa/Carbidopa/Entacapone Orion Norway 15.9.2016 EU/1/11/711 Matever Iceland 14.7.2016 EU/1/11/711 Matever Norway 7.7.2016 EU/1/11/711 Matever Liechtenstein 31.8.2016 EU/1/11/712 Levetiracetam Accord Iceland 10.8.2016 EU/1/11/712 Levetiracetam Accord Norway 11.8.2016 EU/1/11/712 Levetiracetam Accord Liechtenstein 31.8.2016 EU/1/11/713 Levetiracetam Actavis Iceland 5.10.2016 EU/1/11/713 Levetiracetam Actavis Norway 30.9.2016 EU/1/11/713 Levetiracetam Actavis Liechtenstein 31.10.2016 EU/1/11/715 Plenadren Iceland 15.8.2016 EU/1/11/715 Plenadren Norway 15.8.2016 EU/1/11/715 Plenadren Liechtenstein 31.8.2016 EU/1/11/716 Eurartesim Iceland 15.9.2016 EU/1/11/716 Eurartesim Norway 15.9.2016 EU/1/11/716 Eurartesim Liechtenstein 31.10.2016 EU/1/11/717 Vyndaqel Iceland 10.8.2016 EU/1/11/717 Vyndaqel Norway 11.8.2016 EU/1/11/717 Vyndaqel Liechtenstein 31.8.2016 EU/1/11/719 Telmisartan Teva Pharma Iceland 12.7.2016 EU/1/11/722 Pioglitazone Accord Iceland 13.12.2016 EU/1/11/722 Pioglitazone Accord Norway 21.12.2016 EU/1/11/727 Xaluprine Liechtenstein 31.12.2016 EU/1/11/727 Xaluprine Iceland 6.12.2016 EU/1/11/727 Xaluprine Norway 5.12.2016 EU/1/11/728 Pramipexole Accord Iceland 26.7.2016 EU/1/11/728 Pramipexole Accord Norway 4.8.2016 EU/1/11/728 Pramipexole Accord Liechtenstein 31.8.2016 EU/1/11/731 Komboglyze Iceland 26.7.2016 EU/1/11/731 Komboglyze Norway 11.8.2016 EU/1/11/731 Komboglyze Liechtenstein 31.8.2016 EU/1/11/732 Desloratadine Teva Iceland 15.8.2016 EU/1/11/732 Desloratadine Teva Norway 22.8.2016 EU/1/11/733 Dificlir Iceland 29.8.2016 EU/1/11/733 Dificlir Norway 30.8.2016 EU/1/11/733 Dificlir Liechtenstein 31.8.2016 EU/1/11/734 Edarbi Liechtenstein 31.12.2016 EU/1/11/734 Edarbi Iceland 2.12.2016 EU/1/11/734 Edarbi Norway 22.11.2016 EU/1/11/736 EDURANT Iceland 10.8.2016 EU/1/11/736 EDURANT Norway 11.8.2016 EU/1/11/736 EDURANT Liechtenstein 31.8.2016 EU/1/11/737 Eviplera Iceland 10.8.2016 EU/1/11/737 Eviplera Norway 11.8.2016 EU/1/11/737 Eviplera Liechtenstein 31.8.2016 EU/1/11/738 Levetiracetam Actavis Group Iceland 15.8.2016 EU/1/11/738 Levetiracetam Actavis Group Norway 2.9.2016 EU/1/11/738 Levetiracetam Actavis Group Liechtenstein 31.8.2016 EU/1/11/739 Dasselta Iceland 22.8.2016 EU/1/11/739 Dasselta Norway 5.9.2016 EU/1/11/739 Dasselta Liechtenstein 31.8.2016 EU/1/11/740 Ameluz Liechtenstein 31.12.2016 EU/1/11/740 Ameluz Iceland 7.12.2016 EU/1/11/740 Ameluz Norway 5.12.2016 EU/1/11/741 Levetiracetam SUN Liechtenstein 31.12.2016 EU/1/11/741 Levetiracetam Sun Iceland 5.12.2016 EU/1/11/741 Levetiracetam SUN Norway 23.11.2016 EU/1/11/742 Efavirenz Teva Iceland 16.10.2016 EU/1/11/742 Efavirenz Teva Norway 21.10.2016 EU/1/11/743 Repaglinide Accord Iceland 14.10.2016 EU/1/11/743 Repaglinide Accord Norway 21.10.2016 EU/1/11/745 Desloratadin Actavis Liechtenstein 31.12.2016 EU/1/11/745 Desloratadine Actavis Iceland 2.12.2016 EU/1/11/745 Desloratadine Actavis Norway 25.11.2016 EU/1/11/746 Desloratadine ratiopharm Iceland 15.8.2016 EU/1/11/746 Desloratadine ratiopharm Norway 22.8.2016 EU/1/11/746 Desloratadine ratiopharm Liechtenstein 31.8.2016 EU/1/11/747 Colobreathe Iceland 10.10.2016 EU/1/11/747 Colobreathe Norway 13.10.2016 EU/1/11/747 Colobreathe Liechtenstein 31.10.2016 EU/1/12/750 Esmya Liechtenstein 31.12.2016 EU/1/12/750 Esmya Iceland 5.12.2016 EU/1/12/750 Esmya Norway 29.11.2016 EU/1/12/751 Zelboraf Norway 6.10.2016 EU/1/12/751 Zelboraf Iceland 10.10.2016 EU/1/12/751 Zelboraf Liechtenstein 31.10.2016 EU/1/12/753 Signifor Liechtenstein 31.12.2016 EU/1/12/753 Signifor Iceland 6.12.2016 EU/1/12/753 Signifor Norway 24.11.2016 EU/1/12/755 Pioglitazone Actavis Liechtenstein 31.12.2016 EU/1/12/755 Pioglitazone Actavis Norway 9.12.2016 EU/1/12/755 Pioglitazone Actavis Iceland 2.12.2016 EU/1/12/756 Glidipion Norway 9.12.2016 EU/1/12/756 Glidipion Liechtenstein 31.12.2016 EU/1/12/756 Glidipion Iceland 2.12.2016 EU/1/12/763 Ecansya Norway 23.12.2016 EU/1/12/793 XALKORI Iceland 10.8.2016 EU/1/12/793 XALKORI Norway 12.8.2016 EU/1/12/793 XALKORI Liechtenstein 31.8.2016 EU/1/12/794 ADCETRIS Liechtenstein 31.10.2016 EU/1/12/794 ADCETRIS Iceland 2.11.2016 EU/1/12/794 ADCETRIS Norway 8.11.2016 EU/1/15/1047 Blincyto Iceland 10.10.2016 EU/1/15/1047 Blincyto Norway 29.9.2016 EU/1/15/1047 Blincyto Liechtenstein 31.10.2016 EU/1/16/1086 Tagrisso Iceland 19.12.2016 EU/2/06/061 Nobilis Influenza H5N2 Iceland 13.7.2016 EU/2/11/128 Emdocam Iceland 13.7.2016 EU/2/11/132 Nobivac Myxo-RHD Iceland 25.8.2016 EU/2/11/132 Nobivac Myxo-RHD Norway 30.8.2016 EU/2/11/132 Nobivac Myxo-RHD Liechtenstein 31.10.2016 EU/2/11/133 Recocam Iceland 17.8.2016 EU/2/11/133 Recocam Norway 25.8.2016 EU/2/11/133 Recocam Liechtenstein 31.8.2016 EU/2/11/134 Inflacam Liechtenstein 31.12.2016 EU/2/11/134 Inflacam Iceland 2.12.2016 EU/2/11/134 Inflacam Norway 25.11.2016 EU/2/11/135 Panacur AquaSol Liechtenstein 31.8.2016 EU/2/11/135 Panacur AquaSol Iceland 2.9.2016 EU/2/11/135 Panacur AquaSol Norway 5.9.2016 EU/2/11/137 Activyl Tick Plus Norway 23.12.2016 EU/2/12/139 Zulvac 1+8 Bovis Iceland 19.12.2016

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 2016: EU Number Product Country Date of authorisation EU/1/03/267/012 Reyataz Iceland 13.7.2016 EU/1/08/494/005 Stelara Norway 24.11.2016 EU/1/08/494/005 Stelara Iceland 5.12.2016 EU/1/11/714/002-003 Zytiga Iceland 1.12.2016 EU/1/11/714/003 Zytiga Norway 25.11.2016 EU/1/12/776/024 Fycompa Iceland 11.10.2016 EU/1/12/776/024 Fycompa Norway 10.10.2016 EU/1/14/939/005-006 Daklinza Iceland 13.7.2016 EU/1/14/939/005-006 Daklinza Norway 4.7.2016 EU/1/15/1024/002 KEYTRUDA Iceland 24.8.2016 EU/1/15/1024/002 KEYTRUDA Norway 26.8.2016 EU/2/97/004/050-053 Metacam Norway 29.8.2016

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 2016: EU Number Product Country Date of withdrawal EU/1/00/137 Avandia Iceland 12.8.2016 EU/1/03/258 Avandamet Iceland 12.8.2016 EU/1/07/385 Focetria Iceland 12.8.2016 EU/1/08/489 Opgenra Iceland 14.7.2016 EU/1/08/489 Opgenra Norway 11.8.2016 EU/1/08/489 Opgenra Liechtenstein 31.8.2016 EU/1/08/500 Fablyn Iceland 12.8.2016 EU/1/08/506 Celvapan Iceland 7.12.2016 EU/1/08/506 Celvapan Liechtenstein 31.12.2016 EU/1/08/506 Celvapan Norway 21.12.2016 EU/1/09/518 PANTECTA Control Iceland 7.10.2016 EU/1/09/518 PANTECTA Control Norway 20.10.2016 EU/1/09/518 PANTECTA Control Liechtenstein 31.10.2016 EU/1/09/563 ChondroCelect Liechtenstein 31.8.2016 EU/1/09/563 ChondroCelect Iceland 15.8.2016 EU/1/09/563 ChondroCelect Norway 11.8.2016 EU/1/10/657 Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia Iceland 12.8.2016 EU/1/11/721 Paglitaz Iceland 12.8.2016 EU/1/12/810 Krystexxa Iceland 14.7.2016 EU/1/12/810 Krystexxa Norway 6.7.2016 EU/1/12/810 Krystexxa Liechtenstein 31.8.2016 EU/1/13/831 Capecitabine SUN Iceland 13.7.2016 EU/1/13/831 Capecitabine SUN Norway 6.7.2016 EU/1/13/883 Vitekta Iceland 10.11.2016 EU/1/13/883 Vitekta Liechtenstein 31.12.2016 EU/1/13/883 Vitekta Norway 15.12.2016 EU/1/14/942 Clopidogrel/Acetylsalicylic acid Teva Iceland 26.7.2016