Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2015
Date: 2016-09-22
Institutions: Standing Committee of the EFTA States
Subjects: EFTA countries, free movement of goods, market approval, medicinal product, withdrawal from the market








C_2016347EN.01001901.xml










22.9.2016   


EN


Official Journal of the European Union


C 347/19





Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2015
(2016/C 347/05)

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 2015, at their meeting on 18 March 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List of withdrawn marketing authorisations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 July-31 December 2015:








EU Number


Product


Country


Date of authorisation




EU/1/11/710


Votubia (switch to non-conditional)


Liechtenstein


31.12.2015




EU/1/13/895


Kolbam


Iceland


14.12.2015




EU/1/13/895


Kolbam


Norway


15.12.2015




EU/1/13/895


Kolbam


Liechtenstein


31.12.2015




EU/1/15/1005


Aripiprazole Pharmathen


Iceland


23.7.2015




EU/1/15/1005


Aripiprazole Pharmathen


Liechtenstein


31.8.2015




EU/1/15/1005


Aripiprazole Pharmathen


Norway


16.7.2015




EU/1/15/1006


Respreeza


Iceland


31.8.2015




EU/1/15/1006


Respreeza


Liechtenstein


31.8.2015




EU/1/15/1006


Respreeza


Norway


28.8.2015




EU/1/15/1007


Gardasil 9


Iceland


8.7.2015




EU/1/15/1008


Hetlioz


Iceland


4.8.2015




EU/1/15/1008


Hetlioz


Liechtenstein


31.8.2015




EU/1/15/1008


Hetlioz


Norway


16.7.2015




EU/1/15/1009


Aripiprazole Zentiva


Iceland


23.7.2015




EU/1/15/1009


Aripiprazole Zentiva


Norway


16.7.2015




EU/1/15/1010


Duloxetine Mylan


Iceland


9.7.2015




EU/1/15/1010


Duloxetine Mylan


Norway


9.7.2015




EU/1/15/1011


Pregabalin Sandoz


Iceland


10.7.2015




EU/1/15/1011


Pregabalin Sandoz


Norway


17.7.2015




EU/1/15/1012


Pregabalin Sandoz GmbH


Iceland


10.7.2015




EU/1/15/1012


Pregabalin Sandoz GmbH


Norway


17.7.2015




EU/1/15/1013


Lumark


Norway


13.7.2015




EU/1/15/1013


Lumark


Iceland


10.7.2015




EU/1/15/1014


OPDIVO


Iceland


10.7.2015




EU/1/15/1014


Opdivo


Norway


2.7.2015




EU/1/15/1015


Strensiq


Iceland


10.9.2015




EU/1/15/1015


Strensiq


Liechtenstein


31.10.2015




EU/1/15/1015


Strensiq


Norway


14.9.2015




EU/1/15/1016


Repatha


Iceland


14.8.2015




EU/1/15/1016


Repatha


Liechtenstein


31.8.2015




EU/1/15/1016


Repatha


Norway


5.8.2015




EU/1/15/1017


Docetaxel Hospira UK Limited


Iceland


4.9.2015




EU/1/15/1017


Docetaxel Hospira UK limited


Liechtenstein


31.10.2015




EU/1/15/1017


Docetaxel Hospira UK Limited


Norway


7.9.2015




EU/1/15/1018


Omidria


Iceland


19.8.2015




EU/1/15/1018


Omidria


Liechtenstein


31.8.2015




EU/1/15/1018


Omidria


Norway


26.8.2015




EU/1/15/1019


Bortezomib Accord


Iceland


19.8.2015




EU/1/15/1019


Bortezomib Accord


Liechtenstein


31.8.2015




EU/1/15/1019


Bortezomib Accord


Norway


11.8.2015




EU/1/15/1020


Raxone


Iceland


15.9.2015




EU/1/15/1020


Raxone


Liechtenstein


31.10.2015




EU/1/15/1020


Raxone


Norway


30.9.2015




EU/1/15/1021


Pregabalin Zentiva


Iceland


14.8.2015




EU/1/15/1021


Pregabalin Zentiva


Liechtenstein


31.8.2015




EU/1/15/1021


Pregabalin Zentiva


Norway


10.8.2015




EU/1/15/1022


Unituxin


Iceland


21.8.2015




EU/1/15/1022


Unituxin


Liechtenstein


31.8.2015




EU/1/15/1022


Unituxin


Norway


25.8.2015




EU/1/15/1023


Farydak


Iceland


4.9.2015




EU/1/15/1023


Farydak


Liechtenstein


31.10.2015




EU/1/15/1023


Farydak


Norway


7.9.2015




EU/1/15/1024


Keytruda


Iceland


13.8.2015




EU/1/15/1024


Keytruda


Liechtenstein


31.8.2015




EU/1/15/1024


Keytruda


Norway


11.8.2015




EU/1/15/1025


Evotaz


Iceland


12.8.2015




EU/1/15/1025


Evotaz


Liechtenstein


31.8.2015




EU/1/15/1025


Evotaz


Norway


10.8.2015




EU/1/15/1026


Nivolumab BMS


Iceland


28.12.2015




EU/1/15/1026


Nivolumab BMS


Liechtenstein


31.8.2015




EU/1/15/1026


Nivolumab BMS


Norway


11.8.2015




EU/1/15/1027


Pregabalin Accord


Iceland


2.9.2015




EU/1/15/1027


Pregabalin Accord


Liechtenstein


31.10.2015




EU/1/15/1027


Pregabalin Accord


Norway


7.9.2015




EU/1/15/1028


Duloxetine Zentiva


Iceland


31.8.2015




EU/1/15/1028


Duloxetine Zentiva


Liechtenstein


31.8.2015




EU/1/15/1028


Duloxetine Zentiva


Norway


23.9.2015




EU/1/15/1029


Aripiprazole Sandoz


Iceland


31.8.2015




EU/1/15/1029


Aripiprazole Sandoz


Liechtenstein


31.8.2015




EU/1/15/1029


Aripiprazole Sandoz


Norway


25.8.2015




EU/1/15/1030


Odomzo


Iceland


1.9.2015




EU/1/15/1030


Odomzo


Liechtenstein


31.8.2015




EU/1/15/1030


Odomzo


Norway


4.9.2015




EU/1/15/1031


Praluent


Iceland


16.10.2015




EU/1/15/1031


Praluent


Liechtenstein


31.10.2015




EU/1/15/1031


Praluent


Norway


1.10.2015




EU/1/15/1032


Zerbaxa


Iceland


23.9.2015




EU/1/15/1032


Zerbaxa


Liechtenstein


31.10.2015




EU/1/15/1032


Zerbaxa


Norway


13.10.2015




EU/1/15/1033


Kanuma


Iceland


2.9.2015




EU/1/15/1033


Kanuma


Liechtenstein


31.8.2015




EU/1/15/1033


Kanuma


Norway


10.9.2015




EU/1/15/1034


Pemetrexed Lilly


Iceland


21.9.2015




EU/1/15/1034


Pemetrexed Lilly


Liechtenstein


31.10.2015




EU/1/15/1034


Pemetrexed Lilly


Norway


21.9.2015




EU/1/15/1035


Obizur


Iceland


18.11.2015




EU/1/15/1035


Obizur


Norway


30.11.2015




EU/1/15/1035


Obizur


Liechtenstein


31.12.2015




EU/1/15/1036


Cresemba


Iceland


23.10.2015




EU/1/15/1036


Cresemba


Liechtenstein


31.10.2015




EU/1/15/1036


Cresemba


Norway


11.11.2015




EU/1/15/1037


Pemetrexed Sandoz


Iceland


15.10.2015




EU/1/15/1037


Pemetrexed Sandoz


Liechtenstein


31.10.2015




EU/1/15/1037


Pemetrexed Sandoz


Norway


24.9.2015




EU/1/15/1038


Pemetrexed medac


Iceland


11.12.2015




EU/1/15/1038


Pemetrexed medac


Norway


14.12.2015




EU/1/15/1038


Pemetrexed medac


Liechtenstein


31.12.2015




EU/1/15/1039


Fexeric


Iceland


16.10.2015




EU/1/15/1039


Fexeric


Liechtenstein


31.10.2015




EU/1/15/1039


Fexeric


Norway


13.10.2015




EU/1/15/1040


Intuniv


Iceland


21.9.2015




EU/1/15/1040


Intuniv


Liechtenstein


31.10.2015




EU/1/15/1040


Intuniv


Norway


23.9.2015




EU/1/15/1041


Ivabradine Anpharm


Iceland


15.10.2015




EU/1/15/1041


Ivabradine Anpharm


Liechtenstein


31.10.2015




EU/1/15/1041


Ivabradine Anpharm


Norway


1.10.2015




EU/1/15/1042


Zalviso


Liechtenstein


31.10.2015




EU/1/15/1042


Zalviso


Iceland


16.10.2015




EU/1/15/1042


Zalviso


Norway


13.10.2015




EU/1/15/1043


Nucala


Iceland


29.12.2015




EU/1/15/1043


Nucala


Norway


10.12.2015




EU/1/15/1043


Nucala


Liechtenstein


31.12.2015




EU/1/15/1044


Numient


Iceland


14.12.2015




EU/1/15/1044


Numient


Norway


22.12.2015




EU/1/15/1044


Numient


Liechtenstein


31.12.2015




EU/1/15/1045


Aripiprazole Accord


Iceland


20.11.2015




EU/1/15/1045


Aripiprazole Accord


Norway


3.12.2015




EU/1/15/1045


Aripiprazole Accord


Liechtenstein


31.12.2015




EU/1/15/1046


Elocta


Iceland


11.12.2015




EU/1/15/1046


Elocta


Norway


17.12.2015




EU/1/15/1046


Elocta


Liechtenstein


31.12.2015




EU/1/15/1047


Blincyto


Iceland


23.12.2015




EU/1/15/1047


Blincyto


Norway


1.12.2015




EU/1/15/1047


Blincyto


Liechtenstein


31.12.2015




EU/1/15/1048


Cotellic


Iceland


11.12.2015




EU/1/15/1048


Cotellic


Norway


30.11.2015




EU/1/15/1048


Cotellic


Liechtenstein


31.12.2015




EU/1/15/1050


Ionsys


Iceland


24.11.2015




EU/1/15/1050


Ionsys


Norway


10.12.2015




EU/1/15/1050


Ionsys


Liechtenstein


31.12.2015




EU/1/15/1051


Ebymect


Iceland


23.11.2015




EU/1/15/1051


Ebymect


Norway


10.12.2015




EU/1/15/1051


Ebymect


Liechtenstein


31.12.2015




EU/1/15/1052


Edistride


Iceland


17.11.2015




EU/1/15/1052


Edistride


Norway


3.12.2015




EU/1/15/1052


Edistride


Liechtenstein


31.12.2015




EU/1/15/1054


Cinacalcet Mylan


Iceland


24.11.2015




EU/1/15/1054


Cinacalcet Mylan


Norway


30.11.2015




EU/1/15/1054


Cinacalcet Mylan


Liechtenstein


31.12.2015




EU/1/15/1055


Ciambra


Iceland


29.12.2015




EU/1/15/1055


Ciambra


Norway


10.12.2015




EU/1/15/1055


Ciambra


Liechtenstein


31.12.2015




EU/1/15/1056


Praxbind


Iceland


11.12.2015




EU/1/15/1056


Praxbind


Norway


10.12.2015




EU/1/15/1056


Praxbind


Liechtenstein


31.12.2015




EU/1/15/1057


Pemetrexed Hospira


Iceland


11.12.2015




EU/1/15/1057


Pemetrexed Hospira


Norway


1.12.2015




EU/1/15/1057


Pemetrexed Hospira


Liechtenstein


31.12.2015




EU/1/15/1058


Entresto


Iceland


11.12.2015




EU/1/15/1058


Entresto


Norway


26.11.2015




EU/1/15/1058


Entresto


Liechtenstein


31.12.2015




EU/1/15/1059


Orkambi


Iceland


8.12.2015




EU/1/15/1059


Orkambi


Norway


10.12.2015




EU/1/15/1059


Orkambi


Liechtenstein


31.12.2015




EU/1/15/1060


Kyprolis


Iceland


24.11.2015




EU/1/15/1060


Kyprolis


Norway


1.12.2015




EU/1/15/1060


Kyprolis


Liechtenstein


31.12.2015




EU/1/15/1061


Genvoya


Iceland


9.12.2015




EU/1/15/1061


Genvoya


Norway


10.12.2015




EU/1/15/1061


Genvoya


Liechtenstein


31.12.2015




EU/1/15/1062


Ravicti


Iceland


15.12.2015




EU/1/15/1062


Ravicti


Norway


10.12.2015




EU/1/15/1062


Ravicti


Liechtenstein


31.12.2015




EU/1/15/993


Lixiana


Iceland


10.7.2015




EU/1/15/993


Lixiana


Norway


6.7.2015




EU/1/15/997


Pregabalin Mylan


Iceland


13.7.2015




EU/1/15/997


Pregabalin Mylan


Liechtenstein


31.8.2015




EU/1/15/997


Pregabalin Mylan


Norway


16.7.2015




EU/1/15/998


Pregabalin Mylan Pharma


Iceland


13.7.2015




EU/1/15/998


Pregabalin Mylan Pharma


Liechtenstein


31.8.2015




EU/1/15/998


Pregabalin Mylan Pharma


Norway


16.7.2015




EU/2/15/181


Sileo


Iceland


8.7.2015




EU/2/15/182


Innovax ILT


Liechtenstein


31.8.2015




EU/2/15/182


Innovax-ILT


Iceland


24.7.2015




EU/2/15/182


Innovax-ILT


Norway


30.7.2015




EU/2/15/183


Canigen L4


Iceland


6.8.2015




EU/2/15/183


Canigen L4


Liechtenstein


31.8.2015




EU/2/15/183


Canigen L4


Norway


30.7.2015




EU/2/15/184


UpCard


Iceland


20.8.2015




EU/2/15/184


UpCard


Liechtenstein


31.10.2015




EU/2/15/184


UpCard


Norway


10.8.2015




EU/2/15/185


Fortekor Plus


Iceland


21.9.2015




EU/2/15/185


Fortekor Plus


Liechtenstein


31.10.2015




EU/2/15/185


Fortekor Plus


Norway


6.10.2015




EU/2/15/186


Novaquin


Iceland


15.9.2015




EU/2/15/186


Novaquin


Liechtenstein


31.10.2015




EU/2/15/186


Novaquin


Norway


6.10.2015




EU/2/15/187


Porcilis PCV ID


Iceland


2.9.2015




EU/2/15/187


Porcilis PCV ID


Liechtenstein


31.10.2015




EU/2/15/187


Porcilis PCV ID


Norway


9.9.2015




EU/2/15/188


Vectormune ND


Iceland


21.9.2015




EU/2/15/188


Vectormune ND


Liechtenstein


31.10.2015




EU/2/15/188


Vectormune ND


Norway


6.10.2015




EU/2/15/189


Zycortal


Iceland


20.11.2015




EU/2/15/189


Zycortal


Norway


3.12.2015




EU/2/15/189


Zycortal


Liechtenstein


31.12.2015




EU/2/15/190


Suvaxyn Circo + MH RTU


Norway


4.12.2015




EU/2/15/190


Suvaxyn Circo + MH RTU


Liechtenstein


31.12.2015




EU/2/15/190


Suvaxyn Circo + MH RTU


Iceland


16.11.2015




EU/2/15/191


Simparica


Iceland


20.11.2015




EU/2/15/191


Simparica


Norway


4.12.2015




EU/2/15/191


Simparica


Liechtenstein


31.12.2015




EU/2/15/192


Velactis


Iceland


30.12.2015




EU/2/15/192


Velactis


Liechtenstein


31.12.2015




EU/2/15/193


Imrestor


Liechtenstein


31.12.2015







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 2015:








EU Number


Product


Country


Date of authorisation




EU/1/00/146


Keppra


Iceland


31.8.2015




EU/1/00/146


Keppra


Liechtenstein


31.10.2015




EU/1/00/146


Keppra


Norway


8.9.2015




EU/1/05/310


Fosavance


Iceland


24.8.2015




EU/1/05/312


Xyrem


Iceland


15.10.2015




EU/1/05/312


Xyrem


Liechtenstein


31.10.2015




EU/1/05/312


Xyrem


Norway


14.10.2015




EU/1/05/315


Aptivus


Iceland


10.7.2015




EU/1/05/315


Aptivus


Norway


2.7.2015




EU/1/05/319


Xolair


Iceland


9.7.2015




EU/1/05/319


Xolair


Norway


7.7.2015




EU/1/05/323


ProQuad


Liechtenstein


31.12.2015




EU/1/05/325


Macugen


Iceland


9.12.2015




EU/1/05/325


Macugen


Norway


30.11.2015




EU/1/05/325


Macugen


Liechtenstein


31.12.2015




EU/1/10/639


Telmisartan Actavis


Iceland


9.7.2015




EU/1/10/639


Telmisartan Actavis


Norway


8.7.2015




EU/1/10/641


Ruconest


Iceland


16.10.2015




EU/1/10/641


Ruconest


Norway


14.10.2015




EU/1/10/641


Ruconest


Liechtenstein


31.12.2015




EU/1/10/642


Ibandronic Acid Teva


Iceland


9.7.2015




EU/1/10/642


Ibandronic Acid Teva


Norway


16.7.2015




EU/1/10/644


PecFent


Iceland


27.8.2015




EU/1/10/644


PecFent


Norway


10.8.2015




EU/1/10/645


Brinavess


Iceland


19.8.2015




EU/1/10/645


Brinavess


Liechtenstein


31.8.2015




EU/1/10/645


Brinavess


Norway


26.8.2015




EU/1/10/646


VPRIV


Iceland


9.7.2015




EU/1/10/646


VPRIV


Norway


7.7.2015




EU/1/10/648


Twynsta


Iceland


1.9.2015




EU/1/10/648


Twynsta


Liechtenstein


31.10.2015




EU/1/10/648


Twynsta


Norway


8.9.2015




EU/1/10/651


Clopidogrel HCS


Iceland


9.7.2015




EU/1/10/651


Clopidogrel HCS


Norway


1.7.2015




EU/1/10/654


Leflunomide ratiopharm


Iceland


10.7.2015




EU/1/10/654


Leflunomide ratiopharm


Norway


2.7.2015




EU/1/10/655


Brilique


Iceland


13.8.2015




EU/1/10/655


Brilique


Liechtenstein


31.8.2015




EU/1/10/655


Brilique


Norway


26.8.2015




EU/1/10/658


Aflunov


Iceland


13.8.2015




EU/1/10/658


Aflunov


Liechtenstein


31.8.2015




EU/1/10/658


Aflunov


Norway


14.8.2015




EU/1/10/659


Iasibon


Norway


20.10.2015




EU/1/10/659


Iasibon


Iceland


14.10.2015




EU/1/10/659


Iasibon


Liechtenstein


31.10.2015




EU/1/10/660


Potactasol


Iceland


22.10.2015




EU/1/10/660


Potactasol


Liechtenstein


31.10.2015




EU/1/10/660


Potactasol


Norway


16.10.2015




EU/1/10/663


Lamivudine/Zidovudine Teva


Norway


10.12.2015




EU/1/10/663


Lamivudine/Zidovudine Teva


Iceland


9.12.2015




EU/1/10/663


Lamivudine/Zidovudine Teva


Liechtenstein


31.12.2015




EU/1/10/665


Entacapone Teva


Iceland


10.12.2015




EU/1/10/665


Entacapone Teva


Norway


10.12.2015




EU/1/10/665


Entacapone Teva


Liechtenstein


31.12.2015




EU/1/11/667


Esbriet


Iceland


15.9.2015




EU/1/11/667


Esbriet


Liechtenstein


31.10.2015




EU/1/11/667


Esbriet


Norway


16.9.2015




EU/1/11/669


Teysuno


Iceland


8.12.2015




EU/1/11/669


Teysuno


Norway


1.12.2015




EU/1/11/669


Teysuno


Liechtenstein


31.12.2015




EU/1/11/672


Xeplion


Liechtenstein


31.12.2015




EU/1/11/673


Ifirmacombi


Iceland


10.12.2015




EU/1/11/673


Ifirmacombi


Norway


30.11.2015




EU/1/11/673


Ifirmacombi


Liechtenstein


31.12.2015




EU/1/11/676


Jevtana


Iceland


10.12.2015




EU/1/11/676


Jevtana


Norway


27.11.2015




EU/1/11/676


Jevtana


Liechtenstein


31.12.2015




EU/1/11/677


Gilenya


Iceland


8.12.2015




EU/1/11/677


Gilenya


Norway


27.11.2015




EU/1/11/678


Halaven


Iceland


9.12.2015




EU/1/11/678


Halaven


Norway


27.11.2015




EU/1/11/678


Halaven


Liechtenstein


31.12.2015




EU/1/11/699


Fampyra


Iceland


25.8.2015




EU/1/11/699


Fampyra


Liechtenstein


31.8.2015




EU/1/11/699


Fampyra


Norway


3.8.2015




EU/1/11/710


Votubia


Iceland


19.8.2015




EU/1/11/710


Votubia


Liechtenstein


31.8.2015




EU/1/11/710


Votubia


Norway


14.8.2015




EU/1/12/793


Xalkori


Iceland


13.8.2015




EU/1/12/793


Xalkori


Liechtenstein


31.8.2015




EU/1/12/793


Xalkori


Norway


17.8.2015




EU/1/12/794


Adcetris


Iceland


15.10.2015




EU/1/12/794


Adcetris


Norway


30.9.2015




EU/1/12/794


Adcetris


Liechtenstein


31.12.2015




EU/1/13/902


Translarna


Iceland


19.8.2015




EU/1/13/902


Translarna


Liechtenstein


31.8.2015




EU/1/13/902


Translarna


Norway


26.8.2016




EU/1/14/987


Holoclar


Norway


17.12.2015




EU/1/14/987


Holoclar


Liechtenstein


31.12.2015




EU/2/05/055


Equilis Te


Iceland


9.7.2015




EU/2/10/108


BTVPUR AlSap 2-4


Iceland


20.8.2015




EU/2/10/108


BTVPUR AlSap 2-4


Liechtenstein


31.8.2015




EU/2/10/108


BTVPUR AlSap 2-4


Norway


10.8.2015




EU/2/10/109


Rhiniseng


Iceland


23.7.2015




EU/2/10/109


Rhiniseng


Norway


29.7.2015




EU/2/10/110


Coxevac


Iceland


20.8.2015




EU/2/10/110


Coxevac


Liechtenstein


31.8.2015




EU/2/10/110


Coxevac


Norway


13.8.2015




EU/2/10/111


Meloxoral


Iceland


15.9.2015




EU/2/10/111


Meloxoral


Liechtenstein


31.10.2015




EU/2/10/111


Meloxoral


Norway


6.10.2015




EU/2/10/112


BTVPUR ALSap 1


Iceland


15.9.2015




EU/2/10/112


BTVPUR AlSap 1


Liechtenstein


31.10.2015




EU/2/10/112


BTVPUR AlSap 1


Norway


6.10.2015




EU/2/10/113


BTVPUR ALSap 1-8


Iceland


15.9.2015




EU/2/10/113


BTVPUR AlSap 1-8


Norway


6.10.2015




EU/2/10/114


Hiprabovis IBR Marker Live


Iceland


20.11.2015




EU/2/10/114


Hiprabovis IBR Marker Live


Norway


3.12.2015




EU/2/10/114


Hiprabovis IBR Marker Live


Liechtenstein


31.12.2015




EU/2/10/117


Purevax Rabies


Iceland


30.12.2015




EU/2/10/117


Purevax Rabies


Norway


18.12.2015




EU/2/10/117


Purevax Rabies


Liechtenstein


31.12.2015







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 2015:








EU Number


Product


Country


Date of authorisation




EU/1/02/240/009-012


Somavert


Iceland


13.8.2015




EU/1/02/240/009-012


Somavert


Norway


6.8.2015




EU/1/04/303/005


Orfadin


Iceland


10.7.2015




EU/1/04/303/005


Orfadin


Norway


13.7.2015




EU/1/06/359/005-006


Suboxone


Iceland


20.11.2015




EU/1/06/359/005-006


Suboxone


Norway


3.12.2015




EU/1/12/782/003-004


Kalydeco


Iceland


8.12.2015




EU/1/12/782/003-004


Kalydeco


Norway


10.12.2015




EU/1/12/782/006


Iclusig


Norway


14.12.2015




EU/1/13/839/006


Iclusig


Iceland


23.12.2015




EU/1/96/016/009


Norvir


Iceland


2.9.2015




EU/1/96/016/009


Norvir


Norway


8.9.2015




EU/2/11/134/021


Inflacam


Iceland


30.12.2015




EU/2/11/134/021


Inflacam


Norway


30.12.2015







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 2015:








EU Number


Product


Country


Date of authorisation




EU/1/01/179


Osigraft


Liechtenstein


31.12.2015




EU/1/08/450


Biograstim


Iceland


22.10.2015




EU/1/08/450


Biograstim


Liechtenstein


31.10.2015




EU/1/08/450


Biograstim


Norway


7.10.2015




EU/1/08/452


Pandemrix


Iceland


17.11.2015




EU/1/11/686


Rasilamlo


Iceland


23.7.2015




EU/1/11/686


Rasilamlo


Norway


18.8.2015




EU/1/14/912


Zoledronic acid Teva Generics


Iceland


12.8.2015




EU/1/14/912


Zoledronic acid Teva Generics


Norway


25.9.2015




EU/1/15/1026


Nivolumab BMS


Iceland


28.12.2015




EU/1/15/1026


Nivolumab BMS


Norway


9.12.2015




EU/1/15/1026


Nivolumab BMS


Liechtenstein


31.12.2015




EU/1/99/102


Sonata


Iceland


6.8.2015




EU/1/99/102


Sonata


Liechtenstein


31.8.2015




EU/1/99/102


Sonata


Norway


18.8.2015




EU/2/06/064


ProMeris


Iceland


7.8.2015




EU/2/06/064


ProMeris


Liechtenstein


31.8.2015




EU/2/06/064


ProMeris


Norway


18.8.2015




EU/2/06/065


ProMeris Duo


Iceland


7.8.2015




EU/2/06/065


ProMeris Duo


Liechtenstein


31.8.2015




EU/2/06/065


ProMeris Duo


Norway


26.8.2015




EU/2/97/003


Dicural


Iceland


6.11.2015




EU/2/97/003


Dicural


Liechtenstein


31.10.2015




EU/2/97/003


Dicural


Norway


1.12.2015







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 2015:








EU Number


Product


Country


Date of suspension




EU/1/02/226


InductOs


Iceland


17.12.2015




EU/1/02/226


InductOs


Norway


1.12.2015




EU/1/02/226


InductOs


Liechtenstein


31.12.2015