Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2013
Date: 2014-11-06
Institutions: Standing Committee of the EFTA States
Subjects: EFTA countries, free movement of goods, market approval, medicinal product








C_2014391EN.01001501.xml










6.11.2014   


EN


Official Journal of the European Union


C 391/15





Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2013
2014/C 391/04

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 July-31 December 2013, at their meeting on 16 May 2014:







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List of withdrawn marketing authorisations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 2013:








EU-Number


Product


Country


Date of authorisation




EU/1/13/818/001-004


Bosulif


Liechtenstein


31.8.2013




EU/1/13/820


Marixino


Iceland


22.8.2013




EU/1/13/822


PHEBURANE


Iceland


21.8.2013




EU/1/13/822


PHEBURANE


Norway


29.8.2013




EU/1/13/830


Stribild


Norway


1.7.2013




EU/1/13/831


Capecitabin SUN


Liechtenstein


31.8.2013




EU/1/13/831


Capecitabine SUN


Iceland


19.7.2013




EU/1/13/831


Capecitabine SUN


Norway


26.7.2013




EU/1/13/832


Stayveer


Liechtenstein


31.8.2013




EU/1/13/832


Stayveer


Iceland


19.7.2013




EU/1/13/832


Stayveer


Norway


24.7.2013




EU/1/13/833


Nuedexta


Liechtenstein


31.8.2013




EU/1/13/833


NUEDEXTA


Iceland


24.7.2013




EU/1/13/833


Nuedexta


Norway


3.7.2013




EU/1/13/836


Memantine ratiopharm


Iceland


9.8.2013




EU/1/13/838


AUBAGIO


Liechtenstein


31.10.2013




EU/1/13/838


AUBAGIO


Iceland


9.9.2013




EU/1/13/838


AUBAGIO


Norway


18.9.2013




EU/1/13/839


Iclusig


Liechtenstein


31.10.2013




EU/1/13/839


Iclusig


Iceland


19.7.2013




EU/1/13/839


Iclusig


Norway


23.7.2013




EU/1/13/840


HyQvia


Liechtenstein


31.10.2013




EU/1/13/841


Spedra


Liechtenstein


31.8.2013




EU/1/13/841


Spedra


Iceland


19.7.2013




EU/1/13/841


Spedra


Norway


19.7.2013




EU/1/13/842


Incresync


Liechtenstein


31.10.2013




EU/1/13/842


Incresync


Iceland


14.10.2013




EU/1/13/842


Incresync


Norway


10.10.2013




EU/1/13/843


Vipdomet


Liechtenstein


31.10.2013




EU/1/13/843


Vipdomet


Iceland


15.10.2013




EU/1/13/843


Vipdomet


Norway


10.10.2013




EU/1/13/844


Vipidia


Liechtenstein


31.10.2013




EU/1/13/844


Vipidia


Iceland


15.10.2013




EU/1/13/844


Vipidia


Norway


10.10.2013




EU/1/13/845


Imatinib Accord


Iceland


18.7.2013




EU/1/13/845


Imatinib Accord


Norway


18.7.2013




EU/1/13/846


Xtandi


Iceland


19.7.2013




EU/1/13/846


Xtandi


Norway


17.7.2013




EU/1/13/847


MACI


Liechtenstein


31.8.2013




EU/1/13/847


MACI


Iceland


24.7.2013




EU/1/13/847


MACI


Norway


17.7.2013




EU/1/13/848


Erivedge


Liechtenstein


31.8.2013




EU/1/13/848


Erivedge


Iceland


8.8.2013




EU/1/13/848


Erivedge


Norway


13.8.2013




EU/1/13/849


Somatropin Biopartners


Liechtenstein


31.8.2013




EU/1/13/849


Somatropin Biopartners


Iceland


22.8.2013




EU/1/13/849


Somatropin Biopartners


Norway


10.9.2013




EU/1/13/850


Pomalidomide Celgene


Iceland


23.8.2013




EU/1/13/850


Pomalidomide Celgene


Liechtenstein


31.10.2013




EU/1/13/850


Pomalidomide Celgene


Norway


15.8.2013




EU/1/13/851


Lojuxta


Liechtenstein


31.8.2013




EU/1/13/851


Lojuxta


Iceland


21.8.2013




EU/1/13/851


Lojuxta


Norway


28.8.2013




EU/1/13/852


Atosiban SUN


Liechtenstein


31.8.2013




EU/1/13/852


Atosiban SUN


Iceland


20.8.2013




EU/1/13/852


Atosiban SUN


Norway


29.8.2013




EU/1/13/853


Remsima


Liechtenstein


31.10.2013




EU/1/13/853


Remsima


Iceland


20.9.2013




EU/1/13/853


Remsima


Norway


17.9.2013




EU/1/13/854


Inflectra


Liechtenstein


31.10.2013




EU/1/13/854


Inflectra


Iceland


20.9.2013




EU/1/13/854


Inflectra


Norway


10.10.2013




EU/1/13/855


Imvanex


Liechtenstein


31.8.2013




EU/1/13/855


IMVANEX


Iceland


23.8.2013




EU/1/13/855


Imvanex


Norway


17.9.2013




EU/1/13/856


Lonquex


Iceland


20.8.2013




EU/1/13/856


Lonquex


Norway


23.8.2013




EU/1/13/857


Voncento


Liechtenstein


31.10.2013




EU/1/13/857


Voncento


Iceland


11.10.2013




EU/1/13/857


Voncento


Norway


16.9.2013




EU/1/13/858


Stivarga


Liechtenstein


31.10.2013




EU/1/13/858


Stivarga


Iceland


19.9.2013




EU/1/13/858


Stivarga


Norway


9.9.2013




EU/1/13/859


Levodopa/Carbidopa/Entacapone Sandoz


Iceland


22.11.2013




EU/1/13/859


Levodopa/Carbidopa/Entacapone Sandoz


Norway


10.12.2013




EU/1/13/860


Nexium Control


Liechtenstein


31.10.2013




EU/1/13/860


Nexium Control


Iceland


9.9.2013




EU/1/13/860


Nexium Control


Norway


6.9.2013




EU/1/13/861


Procysbi


Liechtenstein


31.10.2013




EU/1/13/861


Procysbi


Iceland


23.9.2013




EU/1/13/861


Procysbi


Norway


24.9.2013




EU/1/13/862


Ultibro Breezhaler


Liechtenstein


31.10.2013




EU/1/13/862


Ultibro Breezhaler


Iceland


15.10.2013




EU/1/13/862


Ultibro Breezhaler


Norway


18.10.2013




EU/1/13/863


Xoterna Breezhaler


Liechtenstein


31.10.2013




EU/1/13/863


Xoterna Breezhaler


Iceland


14.10.2013




EU/1/13/863


Xoterna Breezhaler


Norway


18.10.2013




EU/1/13/865


Tafinlar


Liechtenstein


31.10.2013




EU/1/13/865


Tafinlar


Iceland


19.9.2013




EU/1/13/865


Tafinlar


Norway


18.9.2013




EU/1/13/866


Cholib


Liechtenstein


31.10.2013




EU/1/13/866


Cholib


Iceland


19.9.2013




EU/1/13/866


Cholib


Norway


24.9.2013




EU/1/13/867


Provenge


Liechtenstein


31.10.2013




EU/1/13/867


Provenge


Iceland


19.9.2013




EU/1/13/867


Provenge


Norway


24.9.2013




EU/1/13/868


EVARREST


Liechtenstein


31.10.2013




EU/1/13/868


EVARREST


Iceland


21.10.2013




EU/1/13/868


Evarrest


Norway


18.10.2013




EU/1/13/869


Lemtrada


Liechtenstein


31.10.2013




EU/1/13/869


Lemtrada


Iceland


23.9.2013




EU/1/13/869


Lemtrada


Norway


10.10.2013




EU/1/13/870


Orphacol


Liechtenstein


31.10.2013




EU/1/13/870


Orphacol


Iceland


10.10.2013




EU/1/13/870


Orphacol


Norway


25.9.2013




EU/1/13/871


Ovaleap


Liechtenstein


31.10.2013




EU/1/13/871


Ovaleap


Iceland


22.10.2013




EU/1/13/871


Ovaleap


Norway


17.10.2013




EU/1/13/872


Tybost


Liechtenstein


31.10.2013




EU/1/13/872


Tybost


Iceland


11.10.2013




EU/1/13/872


Tybost


Norway


17.10.2013




EU/1/13/873


Xofigo


Liechtenstein


31.12.2013




EU/1/13/873


Xofigo


Iceland


11.12.2013




EU/1/13/873


Xofigo


Norway


9.12.2013




EU/1/13/876


Imatinib Medac


Liechtenstein


31.10.2013




EU/1/13/876


Imatinib medac


Iceland


17.10.2013




EU/1/13/876


Imatinib medac


Norway


16.10.2013




EU/1/13/877


Grastofil


Liechtenstein


31.10.2013




EU/1/13/877


Grastofil


Iceland


12.11.2013




EU/1/13/877


Grastofil


Norway


18.11.2013




EU/1/13/878


Defitelio


Liechtenstein


31.10.2013




EU/1/13/878


Defitelio


Iceland


12.11.2013




EU/1/13/878


Defitelio


Norway


21.11.2013




EU/1/13/879


Giotrif


Iceland


18.10.2013




EU/1/13/879


Giotrif


Norway


16.10.2013




EU/1/13/880


Memantine Accord


Iceland


16.12.2013




EU/1/13/880


Memantine Accord


Norway


17.12.2013




EU/1/13/880


Memantin Accord


Liechtenstein


31.12.2013




EU/1/13/881


Lidocaine/Prilocaine Plethora


Liechtenstein


31.12.2013




EU/1/13/881


Lidocaine/Prilocaine Plethora


Iceland


12.12.2013




EU/1/13/881


Lidocaine/Prilocaine Plethora


Norway


16.12.2013




EU/1/13/882


ABILIFY MAINTENA


Liechtenstein


31.12.2013




EU/1/13/882


ABILIFY MAINTENA


Iceland


12.12.2013




EU/1/13/882


Abilify Maintena


Norway


16.12.2013




EU/1/13/883


Vitekta


Liechtenstein


31.12.2013




EU/1/13/883


Vitekta


Iceland


11.12.2013




EU/1/13/883


Vitekta


Norway


16.12.2013




EU/1/13/884


Invokana


Liechtenstein


31.12.2013




EU/1/13/884


Invokana


Iceland


12.12.2013




EU/1/13/884


Invokana


Norway


16.12.2013




EU/1/13/885


Kadcyla


Liechtenstein


31.12.2013




EU/1/13/885


Kadcyla


Iceland


12.12.2013




EU/1/13/885


Kadcyla


Norway


16.12.2013




EU/1/13/886


Relvar Ellipta


Iceland


11.12.2013




EU/1/13/886


Relvar Ellipta


Liechtenstein


31.12.2013




EU/1/13/886


Relvar Ellipta


Norway


25.11.2013




EU/1/13/887


Fluenz Tetra


Norway


4.12.2013




EU/1/13/888


NovoEight


Liechtenstein


31.12.2013




EU/1/13/888


NovoEight


Iceland


11.12.2013




EU/1/13/888


NovoEight


Norway


16.12.2013




EU/1/13/893


Opsumit


Norway


20.12.2013




EU/2/13/148


Meloxidolor


Norway


6.8.2013




EU/2/13/150


Oncept IL-2


Iceland


18.7.2013




EU/2/13/152


ProZinc


Iceland


8.8.2013




EU/2/13/152


ProZinc


Norway


5.8.2013




EU/2/13/153


Aftovaxpur Doe


Liechtenstein


31.8.2013




EU/2/13/153


Aftovaxpur Doe


Iceland


9.8.2013




EU/2/13/153


Aftovaxpur Doe


Norway


15.7.2013




EU/2/13/154


Apoquel


Liechtenstein


31.10.2013




EU/2/13/154


Apoquel


Iceland


20.9.2013




EU/2/13/154


Apoquel


Norway


12.9.2013




EU/2/13/155


Trifexis


Liechtenstein


31.10.2013




EU/2/13/155


Trifexis


Iceland


14.10.2013




EU/2/13/156


Vectra 3D


Liechtenstein


31.12.2013




EU/2/13/156


Vectra 3D


Iceland


23.12.2013




EU/2/13/157


BROADLINE


Liechtenstein


31.12.2013




EU/2/13/157


BROADLINE


Iceland


23.12.2013







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 2013:








EU-Number


Product


Country


Date of authorisation




EU/1/03/255


Ventavis


Liechtenstein


31.10.2013




EU/1/03/255


Ventavis


Iceland


9.9.2013




EU/1/03/255


Ventavis


Norway


18.9.2013




EU/1/06/380


Prezista


Iceland


11.10.2013




EU/1/06/380


Prezista


Norway


18.10.2013




EU/1/07/440


Tyverb


Iceland


26.8.2013




EU/1/08/444


Ratiograstim


Liechtenstein


31.8.2013




EU/1/08/444


Ratiograstim


Iceland


19.8.2013




EU/1/08/444


Ratiograstim


Norway


15.8.2013




EU/1/08/445


Tevagrastim


Liechtenstein


31.8.2013




EU/1/08/445


Tevagrastim


Iceland


19.8.2013




EU/1/08/445


Tevagrastim


Norway


15.8.2013




EU/1/08/450


Biograstim


Liechtenstein


31.8.2013




EU/1/08/450


Biograstim


Iceland


20.8.2013




EU/1/08/450


Biograstim


Norway


27.8.2013




EU/1/08/456


Velmetia


Norway


11.9.2013




EU/1/08/457


Efficib


Norway


11.9.2013




EU/1/08/466


Bridion


Liechtenstein


31.8.2013




EU/1/08/466


Bridion


Iceland


17.7.2013




EU/1/08/466


Bridion


Norway


19.7.2013




EU/1/08/467


Doribax


Norway


29.7.2013




EU/1/08/468


INTELENCE


Iceland


17.7.2013




EU/1/08/468


Intelence


Norway


24.7.2013




EU/1/08/470


Vimpat


Liechtenstein


31.8.2013




EU/1/08/470


Vimpat


Iceland


21.8.2013




EU/1/08/470


Vimpat


Norway


13.8.2013




EU/1/08/473


Evicel


Liechtenstein


31.12.2013




EU/1/08/473


Evicel


Iceland


16.12.2013




EU/1/08/473


Evicel


Norway


18.12.2013




EU/1/08/477


Ceplene


Liechtenstein


31.10.2013




EU/1/08/477


Ceplene


Iceland


11.9.2013




EU/1/08/477


Ceplene


Norway


18.9.2013




EU/1/08/479


Zypadhera


Iceland


9.9.2013




EU/1/08/479


Zypadhera


Norway


9.9.2013




EU/1/08/480


Ifirmasta


Liechtenstein


31.8.2013




EU/1/08/480


Ifirmasta


Iceland


9.9.2013




EU/1/08/480


Ifirmasta


Norway


11.9.2013




EU/1/08/481


Kuvan


Liechtenstein


31.12.2013




EU/1/08/481


Kuvan


Iceland


11.12.2013




EU/1/08/481


Kuvan


Norway


10.12.2013




EU/1/08/482


Azarga


Iceland


5.9.2013




EU/1/08/482


Azarga


Norway


18.9.2013




EU/1/08/483


Zomarist


Iceland


21.8.2013




EU/1/08/483


Zomarist


Norway


5.9.2013




EU/1/08/484


Icandra


Iceland


21.8.2013




EU/1/08/484


Icandra


Norway


5.9.2013




EU/1/08/485


Jalra


Liechtenstein


31.12.2013




EU/1/08/485


Jalra


Iceland


16.12.2013




EU/1/08/485


Jalra


Norway


16.12.2013




EU/1/08/486


Xiliarx


Liechtenstein


31.12.2013




EU/1/08/486


Xiliarx


Iceland


16.12.2013




EU/1/08/486


Xiliarx


Norway


16.12.2013




EU/1/08/488


Vidaza


Liechtenstein


31.12.2013




EU/1/08/488


Vidaza


Iceland


10.12.2013




EU/1/08/488


Vidaza


Norway


16.12.2013




EU/1/08/489


Opgenra


Liechtenstein


31.12.2013




EU/1/08/489


Opgenra


Iceland


16.12.2013




EU/1/08/489


Opgenra


Norway


16.12.2013




EU/1/08/490


Pramipexole Teva


Iceland


23.9.2013




EU/1/08/490


Pramipexole Teva


Norway


20.9.2013




EU/1/08/491


Rasilez HCT


Liechtenstein


31.12.2013




EU/1/08/491


Rasilez HCT


Iceland


25.11.2013




EU/1/08/491


Rasilez HCT


Norway


18.12.2013




EU/1/08/492


RoActemra


Iceland


17.10.2013




EU/1/08/492


RoActemra


Norway


16.10.2013




EU/1/08/494


Stelara


Liechtenstein


31.10.2013




EU/1/08/494


Stelara


Iceland


14.10.2013




EU/1/08/494


Stelara


Norway


2.10.2013




EU/1/08/495


Zarzio


Liechtenstein


31.12.2013




EU/1/08/495


Zarzio


Iceland


26.11.2013




EU/1/08/495


Zarzio


Norway


16.12.2013




EU/1/08/496


Filgrastim Hexal


Liechtenstein


31.12.2013




EU/1/08/496


Filgrastim Hexal


Iceland


25.11.2013




EU/1/08/496


Filgrastim Hexal


Norway


16.12.2013




EU/1/08/498


Thymanax


Liechtenstein


31.12.2013




EU/1/08/498


Thymanax


Iceland


25.11.2013




EU/1/08/498


Thymanax


Norway


16.12.2013




EU/1/08/499


Valdoxan


Iceland


25.11.2013




EU/1/08/499


Valdoxan


Norway


17.12.2013




EU/1/08/503


Efient


Liechtenstein


31.12.2013




EU/1/08/503


Efient


Iceland


10.12.2013




EU/1/08/503


Efient


Norway


18.12.2013




EU/1/08/504


Firmagon


Iceland


10.12.2013




EU/1/08/504


Firmagon


Norway


16.12.2013




EU/1/08/505


Intanza


Iceland


17.10.2013




EU/1/08/505


Intanza


Norway


22.10.2013




EU/1/08/507


IDflu


Iceland


17.10.2013




EU/1/08/507


IDflu


Norway


22.10.2013




EU/1/10/628


Votrient


Iceland


1.8.2013




EU/1/10/628


Votrient


Norway


13.8.2013




EU/1/11/699


Fampyra


Iceland


17.7.2013




EU/1/11/699


Fampyra


Norway


12.8.2013




EU/1/11/710


Votubia


Liechtenstein


31.8.2013




EU/1/11/710


Votubia


Iceland


9.8.2013




EU/1/11/710


Votubia


Norway


13.8.2013




EU/1/12/793


Xalkori


Iceland


10.9.2013




EU/1/12/793


Xalkori


Norway


26.8.2013




EU/1/12/794


Adcetris


Iceland


9.9.2013




EU/1/12/794


Adcetris


Norway


23.9.2013




EU/1/99/103


ReFacto AF


Liechtenstein


31.12.2013




EU/1/99/103


Refacto AF


Norway


18.12.2013




EU/2/07/075


Circovac


Norway


9.8.2013




EU/2/08/080


Reconcile


Liechtenstein


31.8.2013




EU/2/08/080


Reconcile


Iceland


8.8.2013




EU/2/08/082


Zactran


Liechtenstein


31.8.2013




EU/2/08/082


Zactran


Iceland


9.8.2013




EU/2/08/082


Zactran


Norway


12.8.2013




EU/2/08/084


Trocoxil


Iceland


4.9.2013




EU/2/08/086


Equip WNV


Liechtenstein


31.10.2013




EU/2/08/086


Equip WNV


Iceland


24.9.2013




EU/2/08/087


Masivet


Liechtenstein


31.10.2013




EU/2/08/087


Masivet


Iceland


17.10.2013




EU/2/08/089


Onsior


Iceland


22.11.2013




EU/2/08/091


Porcilis PCV


Liechtenstein


31.12.2013







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 2013:








EU-Number


Product


Country


Date of authorisation




EU/1/00/145/002


Herceptin


Norway


6.9.2013




EU/1/00/145/002


Herceptin


Iceland


9.9.2013




EU/1/02/203/005-007


Kineret


Norway


13.12.2013




EU/1/02/203/005-007


Kineret


Iceland


13.12.2013




EU/1/03/249/016


Vivanza


Norway


5.8.2013




EU/1/03/249/016


Vivanza


Iceland


17.7.2013




EU/1/07/436/003-004


Isentress


Norway


4.7.2013




EU/1/08/469/026-045


Oprymea


Norway


25.11.2013




EU/1/08/469/026-045


Oprymea


Iceland


22.11.2013




EU/1/09/546/005-008


Simponi


Norway


7.10.2013




EU/1/09/546/005-008


Simponi


Iceland


12.9.2013




EU/1/10/612/007-009


Revolade


Norway


10.10.2013




EU/1/10/612/007-009


Revolade


Iceland


11.10.2013




EU/1/10/637/010-013


Leflunomide medac


Norway


27.8.2013




EU/1/10/637/010-013


Leflunomide medac


Iceland


19.8.2013




EU/1/11/706/034-038


Levodopa/Carbidopa/Entacapone Orion


Norway


18.10.2013




EU/1/11/706/034-038


Levodopa/Carbidopa/Entacapone Orion


Iceland


18.7.2013




EU/1/11/710/009-015


Votubia


Norway


13.12.2013




EU/1/12/777/007-012


Inlyta


Norway


18.9.2013




EU/1/12/777/007-012


Inlyta


Iceland


4.9.2013




EU/1/97/030/202-203


Insuman Implantable


Norway


18.10.2013




EU/2/04/044/015-016


Aivlosin


Iceland


23.12.2013




EU/2/08/090/029-031


Loxicom


Norway


26.9.2013




EU/2/09/098/002-007


Melovem


Iceland


21.10.2013




EU/2/10/115/011-019


Comfortis


Norway


6.8.2013




EU/2/10/115/020-021


Comfortis


Iceland


11.12.2013







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 2013:








EU-Number


Product


Country


Date of withdrawal




EU/1/01/189


Replagal


Norway


14.8.2013




EU/1/03/266


Bondenza


Iceland


12.11.2013




EU/1/09/554


Clopidogrel ratiopharm


Norway


25.11.2013




EU/1/10/656


Possia


Liechtenstein


31.8.2013




EU/1/11/687


Hizentra


Norway


14.8.2013




EU/1/11/730


Rasitrio


Iceland


20.9.2013




EU/1/11/730


Rasitrio


Norway


3.9.2013




EU/1/12/754


Sepioglin


Iceland


12.11.2013




EU/2/00/022


Ibaflin


Liechtenstein


31.8.2013




EU/2/09/093


Netvax


Liechtenstein


31.10.2013




EU/2/09/093


Netvax


Iceland


16.10.2013




EU/2/09/093


Netvax


Norway


19.9.2013




EU/2/98/010


Econor


Norway


5.8.2013







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 2013:








EU-Number


Product


Country


Date of suspension




EU/1/09/527


Ribavirin Teva Pharma BV


Liechtenstein


31.8.2013




EU/1/09/527


Ribavirin Teva Pharma BV


Iceland


24.7.2013