Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017
Date: 2018-08-30
Institutions: Standing Committee of the EFTA States
Subjects: EFTA countries, European Economic Area, free movement of goods, market approval, medicinal product, withdrawal from the market








C_2018305EN.01001501.xml










30.8.2018   


EN


Official Journal of the European Union


C 305/15






Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017
(2018/C 305/12)

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 2017, at their meeting on 23 March 2018:






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List of withdrawn marketing authorisations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 2017:








EU Number


Product


Country


Date of authorisation




EU/1/02/226


InductOs


Iceland


18.8.2017




EU/1/15/999


Zykadia (Switch to non-conditional)


Liechtenstein


31.8.2017




EU/1/16/1138


Venclyxto


Liechtenstein


31.12.2017




EU/1/16/1155


Kyntheum


Iceland


16.8.2017




EU/1/16/1155


Kyntheum


Liechtenstein


31.8.2017




EU/1/16/1155


Kyntheum


Norway


14.8.2017




EU/1/17/1179


Veltassa


Iceland


11.8.2017




EU/1/17/1179


Veltassa


Liechtenstein


31.8.2017




EU/1/17/1179


Veltassa


Norway


9.8.2017




EU/1/17/1181


Spherox


Iceland


24.7.2017




EU/1/17/1181


Spherox


Liechtenstein


31.8.2017




EU/1/17/1181


Spherox


Norway


13.9.2017




EU/1/17/1184


Riximyo


Iceland


11.7.2017




EU/1/17/1185


Rixathon


Iceland


11.7.2017




EU/1/17/1191


Dinutuximab beta Apeiron


Liechtenstein


31.8.2017




EU/1/17/1194


Febuxostat Mylan


Iceland


11.7.2017




EU/1/17/1195


Erelzi


Iceland


14.7.2017




EU/1/17/1195


Erelzi


Norway


7.7.2017




EU/1/17/1196


Kevzara


Iceland


14.7.2017




EU/1/17/1196


Kevzara


Norway


5.7.2017




EU/1/17/1197


Oxervate


Iceland


24.7.2017




EU/1/17/1197


OXERVATE


Liechtenstein


31.8.2017




EU/1/17/1197


OXERVATE


Norway


17.7.2017




EU/1/17/1199


Cuprior


Iceland


13.9.2017




EU/1/17/1199


Cuprior


Liechtenstein


31.10.2017




EU/1/17/1199


Cuprior


Norway


13.9.2017




EU/1/17/1200


Besponsa


Iceland


24.7.2017




EU/1/17/1200


Besponsa


Liechtenstein


31.8.2017




EU/1/17/1200


Besponsa


Norway


13.7.2017




EU/1/17/1201


Skilarence


Iceland


14.7.2017




EU/1/17/1201


Skilarence


Norway


7.7.2017




EU/1/17/1202


Ucedane


Iceland


12.7.2017




EU/1/17/1202


Ucedane


Norway


5.7.2017




EU/1/17/1203


Insulin lispro Sanofi


Iceland


11.8.2017




EU/1/17/1203


Insulin Lispro Sanofi


Liechtenstein


31.8.2017




EU/1/17/1203


Insulin lispro Sanofi


Norway


18.8.2017




EU/1/17/1205


Blitzima


Iceland


9.8.2017




EU/1/17/1205


Blitzima


Liechtenstein


31.8.2017




EU/1/17/1205


Blitzima


Norway


1.8.2017




EU/1/17/1206


Tuxella


Iceland


9.8.2017




EU/1/17/1206


Tuxella


Liechtenstein


31.8.2017




EU/1/17/1206


Tuxella


Norway


1.8.2017




EU/1/17/1207


Ritemvia


Liechtenstein


31.8.2017




EU/1/17/1207


Ritemvia


Iceland


10.8.2017




EU/1/17/1207


Ritemvia


Norway


1.8.2017




EU/1/17/1208


Trimbow


Iceland


11.8.2017




EU/1/17/1208


Trimbow


Liechtenstein


31.8.2017




EU/1/17/1208


Trimbow


Norway


9.8.2017




EU/1/17/1209


Reagila


Iceland


9.8.2017




EU/1/17/1209


Reagila


Liechtenstein


31.8.2017




EU/1/17/1209


Reaglia


Norway


9.8.2017




EU/1/17/1210


Efavirenz/Emtricitabin/Tenofovirdisproksil Zentiva


Norway


8.8.2017




EU/1/17/1210


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


Iceland


10.8.2017




EU/1/17/1210


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


Liechtenstein


31.8.2017




EU/1/17/1211


Entecavir Accord


Iceland


5.10.2017




EU/1/17/1211


Entecavir Accord


Liechtenstein


31.10.2017




EU/1/17/1211


Entecavir Accord


Norway


20.10.2017




EU/1/17/1212


Mavenclad


Iceland


13.9.2017




EU/1/17/1212


MAVENCLAD


Norway


30.8.2017




EU/1/17/1212


MAVENCLAD


Liechtenstein


31.8.2017




EU/1/17/1213


Maviret


Iceland


17.8.2017




EU/1/17/1213


Maviret


Liechtenstein


31.8.2017




EU/1/17/1213


Maviret


Norway


7.8.2017




EU/1/17/1214


Bavencio


Iceland


4.10.2017




EU/1/17/1214


Bavencio


Liechtenstein


31.10.2017




EU/1/17/1214


Bavencio


Norway


25.9.2017




EU/1/17/1215


Fotivda


Iceland


13.9.2017




EU/1/17/1215


Fotivda


Liechtenstein


31.8.2017




EU/1/17/1215


Fotivda


Norway


31.8.2017




EU/1/17/1216


Imraldi


Iceland


12.9.2017




EU/1/17/1216


Imraldi


Liechtenstein


31.8.2017




EU/1/17/1216


Imraldi


Norway


11.9.2017




EU/1/17/1217


Nitisinone MendeliKABS


Iceland


19.9.2017




EU/1/17/1217


Nitisinone MendeliKABS


Liechtenstein


31.8.2017




EU/1/17/1217


Nitisinone MendeliKABS


Norway


1.9.2017




EU/1/17/1218


Rydapt


Iceland


4.10.2017




EU/1/17/1218


Rydapt


Liechtenstein


31.10.2017




EU/1/17/1218


Rydapt


Norway


25.9.2017




EU/1/17/1220


Tecentriq


Liechtenstein


31.10.2017




EU/1/17/1220


Tecentriq


Norway


27.9.2017




EU/1/17/1220


Tecentriq


Iceland


5.10.2017




EU/1/17/1221


Kisqali


Iceland


12.9.2017




EU/1/17/1221


Kisqali


Norway


30.8.2017




EU/1/17/1221


Kisqali


Liechtenstein


31.8.2017




EU/1/17/1222


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


Iceland


8.11.2017




EU/1/17/1222


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


Liechtenstein


31.10.2017




EU/1/17/1222


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


Norway


27.9.2017




EU/1/17/1223


Vosevi


Iceland


16.8.2017




EU/1/17/1223


Vosevi


Liechtenstein


31.8.2017




EU/1/17/1223


Vosevi


Norway


8.8.2017




EU/1/17/1224


Xermelo


Iceland


4.10.2017




EU/1/17/1224


Xermelo


Liechtenstein


31.10.2017




EU/1/17/1224


Xermelo


Norway


3.10.2017




EU/1/17/1225


Symtuza


Iceland


5.10.2017




EU/1/17/1225


Symtuza


Liechtenstein


31.10.2017




EU/1/17/1225


Symtuza


Norway


11.10.2017




EU/1/17/1226


Lutathera


Iceland


10.10.2017




EU/1/17/1226


Lutathera


Liechtenstein


31.10.2017




EU/1/17/1226


Lutathera


Norway


3.10.2017




EU/1/17/1227


Entecavir Mylan


Iceland


4.10.2017




EU/1/17/1227


Entecavir Mylan


Liechtenstein


31.10.2017




EU/1/17/1227


Entecavir Mylan


Norway


27.9.2017




EU/1/17/1228


Tookad


Iceland


29.11.2017




EU/1/17/1228


TOOKAD


Liechtenstein


31.12.2017




EU/1/17/1228


TOOKAD


Norway


22.11.2017




EU/1/17/1229


Dupixent


Iceland


10.10.2017




EU/1/17/1229


Dupixent


Liechtenstein


31.10.2017




EU/1/17/1229


Dupixent


Norway


10.10.2017




EU/1/17/1230


Lacosamide Accord


Iceland


5.10.2017




EU/1/17/1230


Lacosamide Accord


Liechtenstein


31.10.2017




EU/1/17/1230


Lacosamide Accord


Norway


27.9.2017




EU/1/17/1232


Miglustat Gen.Orph


Iceland


30.11.2017




EU/1/17/1232


Miglustat Gen.Orph


Liechtenstein


31.12.2017




EU/1/17/1232


Miglustat Gen.Orph


Norway


27.11.2017




EU/1/17/1233


Zubsolv


Iceland


29.11.2017




EU/1/17/1233


Zubsolv


Liechtenstein


31.12.2017




EU/1/17/1233


Zubsolv


Norway


22.11.2017




EU/1/17/1234


Tremfya


Iceland


4.12.2017




EU/1/17/1235


Zejula


Iceland


4.12.2017




EU/1/17/1235


Zejula


Liechtenstein


31.12.2017




EU/1/17/1235


Zejula


Norway


27.11.2017




EU/1/17/1236


Trelegy Ellipta


Iceland


30.11.2017




EU/1/17/1236


Trelegy Ellipta


Liechtenstein


31.12.2017




EU/1/17/1236


Trelegy Ellipta


Norway


22.11.2017




EU/1/17/1237


Elebrato Ellipta


Iceland


30.11.2017




EU/1/17/1237


Elebrato Ellipta


Liechtenstein


31.12.2017




EU/1/17/1237


Elebrato Ellipta


Norway


27.11.2017




EU/1/17/1238


Nyxoid


Iceland


29.11.2017




EU/1/17/1238


Nyxoid


Liechtenstein


31.12.2017




EU/1/17/1238


Nyxoid


Norway


27.11.2017




EU/1/17/1239


VeraSeal


Iceland


30.11.2017




EU/1/17/1239


VeraSeal


Liechtenstein


31.12.2017




EU/1/17/1239


VeraSeal


Norway


1.12.2017




EU/1/17/1240


Cyltezo


Iceland


29.11.2017




EU/1/17/1240


Cyltezo


Liechtenstein


31.12.2017




EU/1/17/1240


Cyltezo


Norway


1.12.2017




EU/1/17/1241


Ontruzant


Iceland


30.11.2017




EU/1/17/1241


Ontruzant


Liechtenstein


31.12.2017




EU/1/17/1241


Ontruzant


Norway


27.11.2017




EU/1/17/1242


Ritonavir Mylan


Iceland


29.11.2017




EU/1/17/1242


Ritonavir Mylan


Liechtenstein


31.12.2017




EU/1/17/1242


Ritonavir Mylan


Norway


22.11.2017




EU/1/17/1243


Imatinib Teva B.V.


Iceland


30.11.2017




EU/1/17/1243


Imatinib Teva B.V.


Liechtenstein


31.12.2017




EU/1/17/1243


Imatinib Teva B.V.


Norway


22.11.2017




EU/1/17/1244


Tacforius


Liechtenstein


31.12.2017




EU/2/16/197


CLYNAV


Iceland


13.7.2017




EU/2/16/197


CLYNAV


Liechtenstein


31.8.2017




EU/2/16/197


CLYNAV


Norway


18.7.2017




EU/2/17/211


Prevomax


Iceland


13.7.2017




EU/2/17/211


Prevomax


Norway


6.7.2017




EU/2/17/212


Exzolt


Iceland


30.8.2017




EU/2/17/212


Exzolt


Liechtenstein


31.10.2017




EU/2/17/212


Exzolt


Norway


15.9.2017




EU/2/17/213


Innovax-ND-IBD


Iceland


11.9.2017




EU/2/17/213


Innovax-ND-IBD


Norway


18.9.2017




EU/2/17/214


VEPURED


Iceland


12.9.2017




EU/2/17/214


VEPURED


Norway


15.9.2017




EU/2/17/215


Suvaxyn PRRS MLV


Iceland


11.9.2017




EU/2/17/215


Suvaxyn PRRS MLV


Liechtenstein


31.10.2017




EU/2/17/215


Suvaxyn PRRS MLV


Norway


18.9.2017




EU/2/17/217


Nobivac LeuFel


Iceland


9.11.2017




EU/2/17/217


Nobivac LeuFel


Liechtenstein


31.12.2017




EU/2/17/217


Nobivac LeuFel


Norway


14.11.2017




EU/2/17/218


Bovilis Blue-8


Iceland


1.12.2017




EU/2/17/218


Bovilis Blue-8


Liechtenstein


31.12.2017




EU/2/17/218


Bovilis Blue-8


Norway


19.12.2017









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 2017:








EU Number


Product


Country


Date of authorisation




EU/1/07/401


alli


Iceland


14.7.2017




EU/1/07/401


alli


Liechtenstein


31.8.2017




EU/1/07/401


alli


Norway


5.7.2017




EU/1/07/402


Increlex


Iceland


12.7.2017




EU/1/07/402


INCRELEX


Norway


5.7.2017




EU/1/07/403


Atriance


Iceland


11.7.2017




EU/1/07/416


Ecalta


Iceland


13.9.2017




EU/1/07/416


Ecalta


Liechtenstein


31.10.2017




EU/1/07/416


Ecalta


Norway


22.9.2017




EU/1/07/421


Glubrava


Iceland


30.11.2017




EU/1/07/421


Glubrava


Liechtenstein


31.12.2017




EU/1/07/421


Glubrava


Norway


22.11.2017




EU/1/07/424


Torisel


Iceland


24.7.2017




EU/1/07/424


Torisel


Liechtenstein


31.8.2017




EU/1/07/424


Torisel


Norway


1.8.2017




EU/1/08/446


Privigen


Iceland


4.12.2017




EU/1/08/446


Privigen


Liechtenstein


31.12.2017




EU/1/08/446


Privigen


Norway


5.12.2017




EU/1/08/453


Prepandrix


Iceland


4.12.2017




EU/1/08/453


Prepandrix


Liechtenstein


31.12.2017




EU/1/08/453


Prepandrix


Norway


5.12.2017




EU/1/12/784


Cuprymina


Iceland


11.8.2017




EU/1/12/784


Cuprymina


Liechtenstein


31.8.2017




EU/1/12/784


Cuprymina


Norway


9.8.2017




EU/1/12/787


Revestive


Iceland


13.7.2017




EU/1/12/787


Revestive


Norway


5.7.2017




EU/1/12/788


Seebri Breezhaler


Iceland


11.8.2017




EU/1/12/788


Seebri Breezhaler


Liechtenstein


31.8.2017




EU/1/12/788


Seebri Breezhaler


Norway


9.8.2017




EU/1/12/789


Enurev Breezhaler


Iceland


24.7.2017




EU/1/12/789


Enurev Breezhaler


Liechtenstein


31.8.2017




EU/1/12/789


Enurev Breezhaler


Norway


9.8.2017




EU/1/12/790


Tovanor Breezhaler


Iceland


14.8.2017




EU/1/12/790


Tovanor Breezhaler


Liechtenstein


31.8.2017




EU/1/12/790


Tovanor Breezhaler


Norway


9.8.2017




EU/1/12/794


Adcetris


Iceland


4.12.2017




EU/1/12/794


ADCETRIS


Liechtenstein


31.12.2017




EU/1/12/794


ADCETRIS


Norway


27.11.2017




EU/1/12/795


Forxiga


Iceland


13.9.2017




EU/1/12/795


Forxiga


Liechtenstein


31.10.2017




EU/1/12/795


Forxiga


Norway


27.9.2017




EU/1/12/796


Picato


Iceland


24.7.2017




EU/1/12/796


Picato


Liechtenstein


31.8.2017




EU/1/12/796


Picato


Norway


8.8.2017




EU/1/12/797


Eylea


Iceland


10.8.2017




EU/1/12/797


Eylea


Liechtenstein


31.8.2017




EU/1/12/797


Eylea


Norway


18.8.2017




EU/1/12/798


Ibandronic acid Accord


Iceland


6.10.2017




EU/1/12/798


Ibandronic acid Accord


Liechtenstein


31.10.2017




EU/1/12/798


Ibandronic acid Accord


Norway


27.9.2017




EU/1/12/799


Memantine Merz


Iceland


24.7.2017




EU/1/12/799


Memantine Merz


Liechtenstein


31.8.2017




EU/1/12/799


Memantine Merz


Norway


9.8.2017




EU/1/12/800


Zoledronic Acid Hospira


Iceland


11.9.2017




EU/1/12/800


Zoledronic acid Hospira


Liechtenstein


31.8.2017




EU/1/12/800


Zoledronsyre Hospira


Norway


4.9.2017




EU/1/12/801


Constella


Iceland


14.9.2017




EU/1/12/801


Constella


Liechtenstein


31.10.2017




EU/1/12/801


Constella


Norway


22.9.2017




EU/1/12/802


Capecitabine medac


Iceland


12.7.2017




EU/1/12/803


NexoBrid


Iceland


30.11.2017




EU/1/12/803


NexoBrid


Liechtenstein


31.12.2017




EU/1/12/803


NexoBrid


Norway


11.12.2017




EU/1/12/805


AMYViD


Iceland


9.10.2017




EU/1/12/805


Amyvid


Liechtenstein


31.10.2017




EU/1/12/805


Amyvid


Norway


3.10.2017




EU/1/12/806


Ryzodeg


Iceland


4.10.2017




EU/1/12/806


Ryzodeg


Liechtenstein


31.10.2017




EU/1/12/806


Ryzodeg


Norway


10.10.2017




EU/1/12/807


Tresiba


Iceland


9.10.2017




EU/1/12/807


Tresiba


Liechtenstein


31.10.2017




EU/1/12/807


Tresiba


Norway


10.10.2017




EU/1/12/808


Imatinib Teva


Iceland


9.10.2017




EU/1/12/808


Imatinib Teva


Liechtenstein


31.10.2017




EU/1/12/808


Imatinib Teva


Norway


27.9.2017




EU/1/12/809


Betmiga


Iceland


6.10.2017




EU/1/12/809


Betmiga


Liechtenstein


31.10.2017




EU/1/12/809


Betmiga


Norway


3.10.2017




EU/1/12/811


Lyxumia


Iceland


6.10.2017




EU/1/12/811


Lyxumia


Liechtenstein


31.10.2017




EU/1/12/811


Lyxumia


Norway


9.10.2017




EU/1/12/812


Bexsero


Iceland


9.10.2017




EU/1/12/812


Bexsero


Liechtenstein


31.10.2017




EU/1/12/812


Bexsero


Norway


3.10.2017




EU/1/12/814


Zaltrap


Iceland


9.10.2017




EU/1/12/814


ZALTRAP


Liechtenstein


31.10.2017




EU/1/12/814


ZALTRAP


Norway


27.9.2017




EU/1/12/815


Selincro


Iceland


30.11.2017




EU/1/12/815


Selincro


Liechtenstein


31.12.2017




EU/1/12/815


Selincro


Norway


1.12.2017




EU/1/13/813


Perjeta


Iceland


19.12.2017




EU/1/13/813


Perjeta


Liechtenstein


31.12.2017




EU/1/13/817


Actelsar HCT


Liechtenstein


31.12.2017




EU/1/13/819


JETREA


Iceland


15.12.2017




EU/1/13/819


JETREA


Liechtenstein


31.12.2017




EU/1/13/819


JETREA


Norway


19.12.2017




EU/1/13/902


Translarna


Iceland


12.7.2017




EU/1/13/902


Translarna


Norway


5.7.2017




EU/1/14/987


Holoclar


Iceland


19.12.2017




EU/1/16/1094


Ninlaro


Iceland


6.10.2017




EU/1/16/1094


Ninlaro


Liechtenstein


31.10.2017




EU/1/16/1094


Ninlaro


Norway


26.9.2017




EU/1/16/1121


Zalmoxis


Iceland


24.7.2017




EU/1/16/1121


Zalmoxis


Liechtenstein


31.8.2017




EU/1/16/1121


Zalmoxis


Norway


4.8.2017




EU/1/16/1138


Venclyxto


Iceland


6.11.2017




EU/1/16/1138


Venclyxto


Norway


14.11.2017




EU/1/16/1139


Ocaliva


Iceland


8.12.2017




EU/1/16/1139


OCALIVA


Liechtenstein


31.12.2017




EU/1/16/1139


OCALIVA


Norway


18.12.2017




EU/1/16/1143


Lartruvo


Iceland


6.10.2017




EU/1/16/1143


Lartruvo


Liechtenstein


31.10.2017




EU/1/16/1143


Lartruvo


Norway


27.9.2017




EU/1/16/1169


Alecensa


Iceland


8.12.2017




EU/1/16/1169


Alecensa


Liechtenstein


31.12.2017




EU/1/16/1169


Alecensa


Norway


15.12.2017




EU/1/43/890


Cometriq


Norway


3.8.2017




EU/2/12/142


Cardalis


Iceland


4.7.2017




EU/2/12/144


Contacera


Iceland


5.12.2017




EU/2/12/144


Contacera


Liechtenstein


31.12.2017




EU/2/12/144


Contacera


Norway


15.12.2017




EU/2/12/145


Kexxtone


Liechtenstein


31.12.2017




EU/2/12/145


Kexxtone


Norway


28.12.2017




EU/2/12/147


Pexion


Iceland


5.12.2017




EU/2/12/147


Pexion


Liechtenstein


31.12.2017




EU/2/12/147


Pexion


Norway


6.12.2017









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 2017:








EU Number


Product


Country


Date of authorisation




EU/1/01/177/002


SonoVue


Norway


4.9.2017




EU/1/03/256/022


Humira


Iceland


19.12.2017




EU/1/03/256/022


Humira


Norway


10.11.2017




EU/1/04/292/013-015


Mimpara


Iceland


15.9.2017




EU/1/04/292/013-015


Mimpara


Norway


28.8.2017




EU/1/06/356/020-022


Exjade


Norway


28.11.2017




EU/1/06/356/020-022


Exjade


Iceland


1.12.2017




EU/1/07/418/011-013


Celsentri


Norway


3.8.2017




EU/1/07/418/011-013


Celsentri


Iceland


13.7.2017




EU/1/07/422/015


Tasigna


Iceland


4.12.2017




EU/1/07/422/015


Tasigna


Norway


28.11.2017




EU/1/07/436/006


Isentress


Iceland


9.8.2017




EU/1/07/436/006


Isentress


Norway


7.8.2017




EU/1/08/481/004-005


Kuvan


Iceland


10.8.2017




EU/1/08/481/004-005


Kuvan


Norway


13.7.2017




EU/1/09/522/003


ellaOne


Iceland


1.12.2017




EU/1/09/522/003


ellaOne


Norway


10.11.2017




EU/1/09/531/022-033


Instanyl


Iceland


6.11.2017




EU/1/09/539/005-006


Samsca


Iceland


5.10.2017




EU/1/09/539/005-006


Samsca


Norway


18.9.2017




EU/1/10/618


Prolia


Norway


27.9.2017




EU/1/11/703


Xgeva


Norway


27.9.2017




EU/1/12/753/018-019


Signifor


Iceland


4.10.2017




EU/1/12/753/018-019


Signifor


Norway


18.9.2017




EU/1/12/787/003


Revestive


Norway


5.7.2017




EU/1/12/787/003


Revestive


Iceland


13.7.2017




EU/1/13/846/002-003


Xtandi


Norway


3.10.2017




EU/1/13/846/002-003


Xtandi


Iceland


6.10.2017




EU/1/13/860/003


Nexium Control


Iceland


11.7.2017




EU/1/13/860/003


Nexium Control


Norway


5.7.2017




EU/1/15/1070/002


Oncaspar


Iceland


19.12.2017









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 2017:








EU Number


Product


Country


Date of withdrawal




EU/1/00/167


Prevenar


Liechtenstein


31.12.2017




EU/1/00/167


Prevenar


Norway


11.12.2017




EU/1/00/167


Prevenar


Iceland


1.12.2017




EU/1/07/394


Optaflu


Norway


18.10.2017




EU/1/07/398


Optimark


Iceland


10.10.2017




EU/1/09/561


Clopidogrel Teva Pharma


Iceland


11.7.2017




EU/1/11/674


Repso


Liechtenstein


31.8.2017




EU/1/11/674


Repso


Norway


8.8.2017




EU/1/11/674


Repso


Iceland


10.8.2017




EU/1/13/868


EVARREST


Liechtenstein


31.12.2017




EU/1/13/868


EVARREST


Norway


28.11.2017




EU/1/13/868


EVARREST


Iceland


4.12.2017




EU/1/14/976


Zontivity


Liechtenstein


31.8.2017




EU/1/15/996


Ristempa


Liechtenstein


31.10.2017




EU/1/15/996


Ristempa


Norway


9.10.2017




EU/1/15/996


Ristempa


Iceland


9.10.2017




EU/1/16/1113


Enzepi


Iceland


11.8.2017




EU/1/16/1113


Enzepi


Liechtenstein


31.8.2017




EU/1/16/1113


Enzepi


Norway


8.8.2017









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 2017:








EU Number


Product


Country


Date of suspension