Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016
Date: 2018-06-07
Institutions: Standing Committee of the EFTA States
Subjects: EFTA countries, free movement of goods, market approval, medicinal product, withdrawal from the market








C_2018195EN.01002601.xml










7.6.2018   


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List of withdrawn marketing authorisations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







ANNEX V
List of suspended marketing authorisations
The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2016:








EU Number


Product


Country


Date of suspension




EU/2/15/192


Velactis


Iceland


30.8.2016




EU/2/15/192


Velactis


Norway


29.8.2016




EU/2/15/192


Velactis


Liechtenstein


31.8.2016