Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first 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.01000301.xml










6.11.2014   


EN


Official Journal of the European Union


C 391/3





Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2013
2014/C 391/03

Subcommitee 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 January - 30 June 2013, at their meeting on 4 April 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List of withdrawn marketing authorisations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 January-30 June 2013:








EU-Number


Product


Country


Date of authorisation




EU/1/12/788/001-006


Seebri Breezhaler


Liechtenstein


30.4.2013




EU/1/12/789/001-006


Enurev Breezhaler


Liechtenstein


30.4.2013




EU/1/12/790/001-006


Tovanor Breezhaler


Liechtenstein


30.4.2013




EU/1/12/791/001


Glybera


Liechtenstein


30.4.2013




EU/1/12/795/001-010


Forxiga


Liechtenstein


30.4.2013




EU/1/12/797/001-002


Eylea


Liechtenstein


30.4.2013




EU/1/12/803/001-002


NexoBrid


Liechtenstein


30.4.2013




EU/1/12/803/001-002


NexoBrid


Iceland


14.1.2013




EU/1/12/803/001-002


NexoBrid


Norway


11.1.2013




EU/1/12/804/001-016


BindRen


Liechtenstein


30.4.2013




EU/1/12/804/001-016


BindRen


Iceland


8.2.2013




EU/1/12/804/001-016


BindRen


Norway


27.2.2013




EU/1/12/805


Amyvid


Liechtenstein


28.2.2013




EU/1/12/805/001-004


AMYViD


Iceland


6.2.2013




EU/1/12/805/001-004


AMYViD


Norway


4.2.2013




EU/1/12/806/001-005


Ryzodeg


Liechtenstein


28.2.2013




EU/1/12/806/001-005


Ryzodeg


Iceland


20.2.2013




EU/1/12/806/001-005


Ryzodeg


Norway


12.2.2013




EU/1/12/807/001-009


Tresiba


Liechtenstein


28.2.2013




EU/1/12/807/001-009


Tresiba


Iceland


20.2.2013




EU/1/12/807/001-009


Tresiba


Norway


12.2.2013




EU/1/12/808/001-040


Imatinib Teva


Liechtenstein


28.2.2013




EU/1/12/808/001-040


Imatinib Teva


Iceland


5.2.2013




EU/1/12/808/001-040


Imatinib Teva


Norway


22.1.2013




EU/1/12/809/001-014


Betmiga


Liechtenstein


28.2.2013




EU/1/12/809/001-014


Betmiga


Iceland


10.1.2013




EU/1/12/809/001-014


Betmiga


Norway


17.1.2013




EU/1/12/810


Krystexxa


Liechtenstein


30.4.2013




EU/1/12/810/001


Krystexxa


Iceland


14.1.2013




EU/1/12/810/001


Krystexxa


Norway


25.1.2013




EU/1/12/811/001-005


Lyxumia


Iceland


12.2.2013




EU/1/12/811/001-005


Lyxumia


Norway


12.2.2013




EU/1/12/812


Bexsero


Liechtenstein


28.2.2013




EU/1/12/812/001-004


Bexsero


Iceland


14.2.2013




EU/1/12/812/001-004


Bexsero


Norway


4.2.2013




EU/1/12/814


Zaltrap


Liechtenstein


28.2.2013




EU/1/12/814/001-003


Zaltrap


Iceland


12.2.2013




EU/1/12/814/001-003


Zaltrap


Norway


27.2.2013




EU/1/12/815/001-005


Selincro


Liechtenstein


30.4.2013




EU/1/12/815/001-005


Selincro


Iceland


19.3.2013




EU/1/12/815/001-005


Selincro


Norway


11.3.2013




EU/1/13/813/001


Perjeta


Liechtenstein


30.4.2013




EU/1/13/813/001


Perjeta


Iceland


20.3.2013




EU/1/13/813/001


Perjeta


Norway


9.4.2013




EU/1/13/817/001-041


Actelsar HCT


Iceland


21.3.2013




EU/1/13/817/001-041


Actelsar HCT


Norway


22.4.2013




EU/1/13/818/001-004


Bosulif


Iceland


15.4.2013




EU/1/13/818/001-004


Bosulif


Norway


30.4.2013




EU/1/13/819/001


JETREA


Liechtenstein


30.4.2013




EU/1/13/819/001


JETREA


Iceland


11.4.2013




EU/1/13/819/001


JETREA


Norway


22.3.2013




EU/1/13/820/001-026


Maruxa


Liechtenstein


30.6.2013




EU/1/13/820/001-026


Maruxa


Norway


24.5.2013




EU/1/13/821/001-030


Tolucombi


Liechtenstein


30.4.2013




EU/1/13/821/001-030


Tolucombi


Iceland


21.3.2013




EU/1/13/821/001-030


Tolucombi


Norway


22.3.2013




EU/1/13/823/001-002


Adasuve


Norway


12.3.2013




EU/1/13/823/001-002


Adasuve


Liechtenstein


30.4.2013




EU/1/13/823/001-002


Adasuve


Iceland


18.3.2013




EU/1/13/824


Nemdatine


Liechtenstein


30.4.2013




EU/1/13/824/001-020


Nemdatine


Iceland


21.5.2013




EU/1/13/824/001-020


Nemdatine


Norway


3.5.2013




EU/1/13/825


Imatinib Actavis


Liechtenstein


30.6.2013




EU/1/13/825/001-018


Imatinib Actavis


Iceland


16.5.2013




EU/1/13/825/001-018


Imatinib Actavis


Norway


20.6.2013




EU/1/13/826


Memantine LEK


Liechtenstein


30.4.2013




EU/1/13/826/001-011


Memantine LEK


Iceland


21.5.2013




EU/1/13/826/001-011


Memantine LEK


Norway


3.5.2013




EU/1/13/827


Memantine Mylan


Liechtenstein


30.4.2013




EU/1/13/827/001-036


Memantine Mylan


Iceland


21.5.2013




EU/1/13/827/001-036


Memantine Mylan


Norway


3.5.2013




EU/1/13/828


Hexacima


Liechtenstein


30.4.2013




EU/1/13/828/001-007


Hexacima


Iceland


17.5.2013




EU/1/13/828/001-007


Hexacima


Norway


15.5.2013




EU/1/13/829


Hexyon


Liechtenstein


30.4.2013




EU/1/13/829/001-007


Hexyon


Iceland


17.5.2013




EU/1/13/829/001-007


Hexyon


Norway


15.5.2013




EU/1/13/830/001-002


Stribild


Iceland


19.6.2013




EU/1/13/830/001-002


Stribild


Norway


24.5.2013




EU/1/13/835/001-018


Voriconazole Accord


Iceland


31.5.2013




EU/1/13/835/001-018


Voriconazole Accord


Norway


31.5.2013




EU/1/13/836


Memantine ratiopharm


Liechtenstein


30.6.2013




EU/1/13/836/001-023


Memantine ratiopharm


Norway


25.6.2013




EU/1/13/840/001-005


HyQvia


Iceland


27.5.2013




EU/1/13/840/001-005


HyQvia


Norway


3.6.2013




EU/2/12/142/001-006


Cardalis


Norway


20.6.2013




EU/2/12/144/001-004


Contacera


Liechtenstein


28.2.2013




EU/2/12/144/001-004


Contacera


Iceland


3.1.2013




EU/2/12/144/001-004


Contacera


Norway


17.1.2013




EU/2/12/145/001-003


Kexxtone


Liechtenstein


30.4.2013




EU/2/12/145/001-003


Kexxtone


Iceland


27.2.2013




EU/2/12/145/001-003


Kexxtone


Norway


8.3.2013




EU/2/12/146/001


Semintra


Liechtenstein


30.4.2013




EU/2/12/146/001


Semintra


Iceland


12.3.2013




EU/2/12/146/001


Semintra


Norway


5.4.2013




EU/2/12/147/001-004


Pexion


Liechtenstein


30.4.2013




EU/2/12/147/001-004


Pexion


Iceland


19.3.2013




EU/2/12/147/001-004


Pexion


Norway


8.3.2013




EU/2/13/148


Meloxidolor


Liechtenstein


30.6.2013




EU/2/13/148/001-007


Meloxidolor


Iceland


21.5.2013




EU/2/13/148/001-007


Meloxidolor


Norway


22.4.2013




EU/2/13/149


ECOPORC SHIGA


Liechtenstein


30.4.2013




EU/2/13/149/001-002


ECOPORC SHIGA


Iceland


15.5.2013




EU/2/13/149/001-002


ECOPORC SHIGA


Norway


13.5.2013




EU/2/13/150


Oncept IL-2


Liechtenstein


30.6.2013




EU/2/13/151/001-003


Equilis West Nile


Iceland


27.6.2013







ANNEX II
List of renewed marketing authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2013:








EU-Number


Product


Country


Date of authorisation




EU/1/03/247


Forsteo


Liechtenstein


30.4.2013




EU/1/03/247/001-002


Forsteo


Iceland


19.2.2013




EU/1/03/247/001-002


Forsteo


Norway


6.3.2013




EU/1/07/423


Vectibix


Liechtenstein


30.4.2013




EU/1/07/423/001-003


Vectibix


Iceland


5.2.2013




EU/1/07/423/001-003


Vectibix


Norway


12.2.2013




EU/1/07/428/001


Abraxane


Liechtenstein


30.4.2013




EU/1/07/428/001


Abraxane


Iceland


5.2.2013




EU/1/07/428/001


Abraxane


Norway


11.2.2013




EU/1/07/430/001-002


Atripla


Liechtenstein


30.4.2013




EU/1/07/433/001


Nevanac


Iceland


9.1.2013




EU/1/07/434


Avamys


Liechtenstein


28.2.2013




EU/1/07/434/001-003


Avamys


Iceland


11.1.2013




EU/1/07/434/001-003


Avamys


Norway


14.1.2013




EU/1/07/435/001-018


Tesavel


Liechtenstein


30.4.2013




EU/1/07/438/001-006


Myfenax


Liechtenstein


30.4.2013




EU/1/07/439/001-006


Mycophenolate mofetil Teva


Liechtenstein


30.4.2013




EU/1/07/440


Tyverb


Liechtenstein


30.4.2013




EU/1/07/440/001-007


Tyverb


Norway


15.5.2013




EU/1/08/441


Effentora


Liechtenstein


30.4.2013




EU/1/08/441/001-010


Effentora


Iceland


20.3.2013




EU/1/08/441/001-010


Effentora


Norway


12.3.2013




EU/1/08/442/001-019


Pradaxa


Norway


26.2.2013




EU/1/08/442/001-019


Pradaxa


Liechtenstein


30.4.2013




EU/1/08/442/001-019


Pradaxa


Iceland


15.2.2013




EU/1/08/443/001


Thalidomide Celgene


Iceland


14.1.2013




EU/1/08/443/001


Thalidomide Celgene


Norway


16.1.2013




EU/1/08/446/001-006


Privigen


Iceland


22.3.2013




EU/1/08/446/001-006


Privigen


Norway


21.3.2013




EU/1/08/447/001-012


Adenuric


Norway


15.1.2013




EU/1/08/447/001-012


Adenuric


Liechtenstein


30.4.2013




EU/1/08/447/001-012


Adenuric


Iceland


14.1.2013




EU/1/08/448/001-002


Mycamine


Liechtenstein


30.4.2013




EU/1/08/448/001-002


Mycamine


Iceland


24.1.2013




EU/1/08/448/001-002


Mycamine


Norway


12.2.2013




EU/1/08/451


Volibris


Liechtenstein


30.4.2013




EU/1/08/451/001-004


Volibris


Iceland


5.2.2013




EU/1/08/451/001-004


Volibris


Norway


12.2.2013




EU/1/08/453


Prepandrix


Liechtenstein


30.4.2013




EU/1/08/453/002


Prepandrix


Iceland


6.2.2013




EU/1/08/453/002


Prepandrix


Norway


4.2.2013




EU/1/08/454/001-002, 005-007


Extavia


Iceland


9.1.2013




EU/1/08/454/001-002, 005-007


Extavia


Liechtenstein


30.4.2013




EU/1/08/454/001-002, 005-007


Extavia


Norway


10.1.2013




EU/1/08/455


Janumet


Liechtenstein


30.4.2013




EU/1/08/455/001-006


Janumet


Norway


10.4.2013




EU/1/08/455/001-016


Janumet


Iceland


25.3.2013




EU/1/08/456


Velmetia


Liechtenstein


30.4.2013




EU/1/08/456/001-016


Velmetia


Iceland


26.3.2013




EU/1/08/457


Efficib


Liechtenstein


30.4.2013




EU/1/08/457/001-016


Efficib


Iceland


26.3.2013




EU/1/08/461


Firazyr


Liechtenstein


30.4.2013




EU/1/08/461/001-002


Firazyr


Iceland


11.4.2013




EU/1/08/461/001-002


Firazyr


Norway


10.4.2013




EU/1/08/462


Ranexa


Liechtenstein


30.4.2013




EU/1/08/462/001-002


Ranexa


Norway


9.4.2013




EU/1/08/462/001-012


Ranexa


Iceland


20.3.2013




EU/1/08/463


Relistor


Liechtenstein


30.6.2013




EU/1/08/463/001-011


Relistor


Iceland


21.6.2013




EU/1/08/463/001-011


Relistor


Norway


26.6.2013




EU/1/08/465


Clopidogrel Zentiva


Liechtenstein


28.2.2013




EU/1/08/465/001-021


Clopidogrel Zentiva


Iceland


3.1.2013




EU/1/08/465/001-021


Clopidogrel Zentiva


Norway


5.2.2013




EU/1/08/467


Doribax


Liechtenstein


30.6.2013




EU/1/08/467/001-002


Doribax


Iceland


17.5.2013




EU/1/08/469


Oprymea


Liechtenstein


30.4.2013




EU/1/08/469/001-025


Oprymea


Iceland


14.5.2013




EU/1/08/469/001-025


Oprymea


Norway


24.5.2013




EU/1/08/472


Xarelto


Liechtenstein


30.6.2013




EU/1/08/472/001-033


Xarelto


Norway


13.6.2013




EU/1/08/472/001-033


Xarelto


Iceland


20.6.2013




EU/1/08/475


Olanzapine Mylan


Liechtenstein


30.6.2013




EU/1/08/475/001-060


Olanzapine Mylan


Iceland


20.6.2013




EU/1/08/475/001-060


Olanzapine Mylan


Norway


7.6.2013




EU/1/08/476


Adcirca


Liechtenstein


30.6.2013




EU/1/08/476/005-006


Adcirca


Iceland


31.5.2013




EU/1/08/476/005-006


Adcirca


Norway


4.6.2013




EU/1/10/625


Arzerra


Liechtenstein


30.4.2013




EU/1/10/625/001, 003


Arzerra


Iceland


15.3.2013




EU/1/10/625/001, 003


Arzerra


Norway


9.4.2013




EU/1/11/749


Caprelsa


Liechtenstein


30.4.2013




EU/1/11/749/001-002


Caprelsa


Iceland


12.3.2013




EU/1/11/749/001-002


Caprelsa


Norway


9.4.2013




EU/1/12/764


Pixuvri


Liechtenstein


30.4.2013




EU/1/12/764/001


Pixuvri


Iceland


12.4.2013




EU/1/12/764/001


Pixuvri


Norway


9.4.2013




EU/1/97/055/001-009


Viramune


Liechtenstein


30.4.2013




EU/1/97/055/001-009


Viramune


Iceland


14.1.2013




EU/1/97/055/001-009


Viramune


Norway


22.1.2013




EU/2/02/032/001-002


Vaxxitec HVT+IBD


Norway


11.6.2013




EU/2/03/037


ProteqFlu


Liechtenstein


30.4.2013




EU/2/03/037/005


ProteqFlu


Iceland


21.3.2013




EU/2/03/037/005


ProteqFlu


Norway


20.6.2013




EU/2/03/038


ProteqFlu-Te


Liechtenstein


30.4.2013




EU/2/03/038/005


ProteqFlu-Te


Iceland


21.3.2013




EU/2/03/038/005


ProteqFlu-Te


Norway


20.6.2013




EU/2/03/039


Advocate


Liechtenstein


28.2.2013




EU/2/03/039/001-054


Advocate


Iceland


19.2.2013




EU/2/03/039/001-054


Advocate


Norway


5.3.2013




EU/2/07/074/001-006


Prilactone


Norway


11.6.2013




EU/2/07/077/001-005


Meloxivet


Norway


5.4.2013




EU/2/07/078


Rheumocam


Liechtenstein


28.2.2013




EU/2/07/078/001-020


Rheumocam


Iceland


11.1.2013




EU/2/07/078/001-020


Rheumocam


Norway


21.1.2013




EU/2/07/079


Ingelvac CircoFLEX


Liechtenstein


30.4.2013




EU/2/07/079/001-008


Ingelvac CircoFLEX


Iceland


7.2.2013




EU/2/07/079/001-008


Ingelvac CircoFLEX


Norway


5.3.2013




EU/2/08/081/001-003


Posatex


Iceland


14.6.2013




EU/2/08/081/001-003


Posatex


Norway


11.6.2013




EU/2/08/083/001-005


Equioxx


Iceland


28.6.2013




EU/2/08/083/001-005


Equioxx


Norway


20.6.2013







ANNEX III
List of extended marketing authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2013:








EU-Number


Product


Country


Date of authorisation




EU/1/01/200/003-009


Viread


Norway


11.1.2013




EU/1/02/221/017


Pegasys


Iceland


26.3.2013




EU/1/02/221/017


Pegasys


Norway


26.3.2013




EU/1/06/380/006-007


Prezista


Liechtenstein


28.2.2013




EU/1/06/380/007


Prezista


Iceland


6.2.2013




EU/1/06/380/007


Prezista


Norway


11.2.2013




EU/1/07/433/002


Nevanac


Norway


24.5.2013




EU/1/07/436/003-004


Isentress


Iceland


19.3.2013




EU/1/07/436/003-004


Isentress


Norway


25.2.2013




EU/1/08/468/003


Intelence


Norway


17.4.2013




EU/1/09/538/009-010


Afinitor


Iceland


5.2.2013




EU/1/09/538/009-010


Afinitor


Norway


16.1.2013




EU/1/09/576/041-042


Irbesartan Teva


Liechtenstein


28.2.2013




EU/1/11/690/003-004


Zoely


Liechtenstein


28.2.2013




EU/1/11/693/017-024


Rivastigmine Actavis


Iceland


17.5.2013




EU/1/11/693/017-024


Rivastigmine Actavis


Norway


25.6.2013




EU/1/12/750/002


Esmya


Liechtenstein


28.2.2013




EU/1/12/770/005


Docetaxel Kabi


Liechtenstein


28.2.2013




EU/1/98/066/027-030


Exelon


Iceland


7.2.2013




EU/1/98/066/027-030


Exelon


Norway


12.2.2013




EU/1/98/077/020-023


Viagra


Iceland


17.5.2013




EU/1/98/077/020-023


Viagra


Norway


15.5.2013




EU/100/146/033-037


Keppra


Liechtenstein


28.2.2013




EU/2/08/090/029-031


Loxicom


Iceland


21.3.2013




EU/2/08/090/029-031


Loxicom


Norway


6.3.2013




EU/2/10/115/016-019


Comfortis


Iceland


8.2.2013




EU/2/10/115/016-019


Comfortis


Norway


14.1.2013




EU/2/11/134/018-020


Inflacam


Norway


17.1.2013







ANNEX IV
List of withdrawn marketing authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2013:








EU-Number


Product


Country


Date of withdrawal




EU/1/03/266


Bondenza


Liechtenstein


30.4.2013




EU/1/03/266/001-006


Bondenza


Norway


12.6.2013




EU/1/07/409


Riprazo


Liechtenstein


30.4.2013




EU/1/07/409/001-040


Riprazo


Iceland


27.5.2013




EU/1/07/409/001-040


Riprazo


Norway


14.3.2013




EU/1/08/458/001-014


Trevaclyn


Iceland


15.5.2013




EU/1/08/458/001-014


Trevaclyn


Norway


23.4.2013




EU/1/08/459/001-014


Tredaptive


Iceland


15.5.2013




EU/1/08/459/001-014


Tredaptive


Norway


23.4.2013




EU/1/08/460/001-014


Pelzont


Iceland


15.5.2013




EU/1/08/460/001-014


Pelzont


Norway


23.4.2013




EU/1/08/474/001-003


Alisade


Iceland


27.6.2013




EU/1/09/582/001


Rilonacept Regeneron


Liechtenstein


28.2.2013




EU/1/09/582/001


Rilonacept Regeneron


Norway


8.2.2013




EU/1/10/656/001-006


Possia


Iceland


15.4.2013




EU/1/10/656/001-006


Possia


Norway


12.6.2013




EU/1/11/683/001-080


Sprimeo HCT


Norway


21.3.2013




EU/1/12/754/001-021


Sepioglin


Norway


20.6.2013




EU/1/97/040/001-002


Teslascan


Liechtenstein


28.2.2013




EU/2/04/046


Nobivac Piro


Liechtenstein


30.6.2013




EU/2/04/046/001-003


Nobivac Piro


Iceland


3.6.2013




EU/2/04/046/001-003


Nobivac Piro


Norway


22.5.2013







ANNEX V
List of suspended marketing authorisations
The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January-30 June 2013:








EU-Number


Product


Country


Date of suspension




EU/1/09/509/001-004


Ribavirin Teva


Norway


3.1.2013




EU/1/09/527/001-006


Ribavirin Teva Pharma BV


Norway


3.1.2013