Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2019 2020/C 308/06 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee
Date: 2020-09-17
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_2020308EN.01000901.xml










17.9.2020   


EN


Official Journal of the European Union


C 308/9






Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2019
(2020/C 308/06)
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 2019, at their meeting on 20 March 2020.






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List of withdrawn marketing authorisations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 2019:








EU-Number


Product


Country


Date of authorisation




EU/2/19/240


Afoxolaner Merial


Iceland


30.8.2019




EU/1/19/1398


Arsenic Trioxide Accord


Iceland


2.12.2019




EU/1/19/1398


Arsenic Trioxide Accord


Liechtenstein


31.12.2019




EU/1/19/1398


Arsenic Trioxide Accord


Norway


26.11.2019




EU/2/18/228


Arti-Cell Forte


Iceland


16.7.2019




EU/1/19/1382


Azacitidin Celgene


Iceland


29.8.2019




EU/1/19/1382


Azacitidin Celgene


Liechtenstein


31.8.2019




EU/1/19/1382


Azacitidin Celgene


Norway


8.8.2019




EU/1/19/1406


BAQSIMI


Iceland


30.12.2019




EU/1/19/1406


BAQSIMI


Liechtenstein


31.12.2019




EU/1/19/1397


Bortezomib Fresenius Kabi


Iceland


29.11.2019




EU/1/19/1397


Bortezomib Fresenius Kabi


Liechtenstein


31.12.2019




EU/1/19/1397


Bortezomib Fresenius Kabi


Norway


10.12.2019




EU/1/19/1365


Cufence


Iceland


9.10.2019




EU/1/19/1365


Cufence


Liechtenstein


31.8.2019




EU/1/19/1365


Cufence


Norway


12.8.2019




EU/1/19/1386


Deferasirox Mylan


Iceland


11.10.2019




EU/1/19/1386


Deferasirox Mylan


Liechtenstein


31.10.2019




EU/1/19/1386


Deferasirox Mylan


Norway


8.10.2019




EU/1/19/1370


Dovato


Iceland


19.7.2019




EU/1/19/1370


Dovato


Liechtenstein


31.8.2019




EU/1/19/1370


Dovato


Norway


04.07.2019




EU/1/19/1389


Epidyolex


Iceland


18.10.2019




EU/1/19/1389


Epidyolex


Liechtenstein


31.10.2019




EU/1/19/1389


Epidyolex


Norway


16.10.2019




EU/1/19/1392


Ervebo


Iceland


4.12.2019




EU/1/19/1392


Ervebo


Liechtenstein


31.12.2019




EU/1/19/1392


Ervebo


Norway


19.11.2019




EU/1/19/1374


Esperoct


Liechtenstein


31.8.2019




EU/1/19/1411


Evenity


Iceland


12.12.2019




EU/1/19/1411


Evenity


Liechtenstein


31.12.2019




EU/2/19/242


EVICTO


Iceland


27.8.2019




EU/2/19/242


EVICTO


Liechtenstein


31.8.2019




EU/2/19/242


EVICTO


Norway


13.08.2019




EU/1/19/1384


Giapreza


Iceland


29.8.2019




EU/1/19/1384


Giapreza


Liechtenstein


31.8.2019




EU/1/19/1384


Giapreza


Norway


25.09.2019




EU/1/19/1375


Grasustek


Iceland


24.7.2019




EU/1/19/1375


Grasustek


Norway


31.10.2019




EU/2/19/245


Gumbohatch


Iceland


29.11.2019




EU/2/19/245


Gumbohatch


Liechtenstein


31.12.2019




EU/2/18/226


HorStem


Iceland


16.7.2019




EU/1/17/1216


Imraldi


Norway


16.09.2019




EU/1/19/1390


Inbrija


Iceland


11.10.2019




EU/1/19/1390


Inbrija


Liechtenstein


31.10.2019




EU/1/19/1390


Inbrija


Norway


16.10.2019




EU/1/19/1396


Ivozall


Iceland


28.11.2019




EU/1/19/1396


Ivozall


Norway


26.11.2019




EU/1/19/1383


Lacosamid UCB


Iceland


3.9.2019




EU/1/19/1383


Lacosamid UCB


Liechtenstein


31.8.2019




EU/1/19/1383


Lacosamid UCB


Norway


18.10.2019




EU/1/19/1376


LIBTAYO


Iceland


19.7.2019




EU/1/19/1376


LIBTAYO


Liechtenstein


31.8.2019




EU/1/19/1376


LIBTAYO


Norway


05.8.2019




EU/1/19/1381


LysaKare


Iceland


26.8.2019




EU/1/19/1381


LysaKare


Liechtenstein


31.8.2019




EU/1/19/1381


LysaKare


Norway


12.8.2019




EU/1/18/1301


Mepsevii


Liechtenstein


31.8.2019




EU/2/19/247


Mirataz


Iceland


30.12.2019




EU/2/19/247


Mirataz


Liechtenstein


31.12.2019




EU/2/19/241


NASYM


Iceland


27.8.2019




EU/2/19/241


NASYM


Liechtenstein


31.8.2019




EU/2/19/241


NASYM


Norway


16.8.2019




EU/2/19/246


Neptra


Iceland


30.12.2019




EU/2/19/246


Neptra


Liechtenstein


31.12.2019




EU/2/19/244


Nobivac Myxo-RHD Plus


Iceland


4.12.2019




EU/2/19/244


Nobivac Myxo-RHD Plus


Liechtenstein


31.12.2019




EU/1/19/1364


Nuceiva


Iceland


18.10.2019




EU/1/19/1364


Nuceiva


Norway


18.10.2019




EU/1/18/1320


Onpattro


Liechtenstein


31.12.2019




EU/1/19/1388


Polivy


Liechtenstein


31.12.2019




EU/1/19/1379


Posaconazole Accord


Iceland


28.8.2019




EU/1/19/1379


Posaconazole Accord


Liechtenstein


31.8.2019




EU/1/19/1379


Posaconazole Accord


Norway


26.8.2019




EU/1/19/1380


Posaconazole AHCL


Iceland


27.8.2019




EU/1/19/1380


Posaconazole AHCL


Liechtenstein


31.8.2019




EU/1/19/1380


Posaconazole AHCL


Norway


12.8.2019




EU/1/19/1401


Qtrilmet


Iceland


18.11.2019




EU/1/19/1401


Qtrilmet


Liechtenstein


31.12.2019




EU/1/19/1401


Qtrilmet


Norway


6.12.2019




EU/1/19/1393


Quofenix


Iceland


30.12.2019




EU/1/19/1393


Quofenix


Liechtenstein


31.12.2019




EU/1/19/1400


Rhokiinsa


Iceland


5.12.2019




EU/1/19/1400


Rhokiinsa


Norway


17.12.2019




EU/1/19/1404


Rinvoq


Iceland


30.12.2019




EU/1/19/1404


Rinvoq


Liechtenstein


31.12.2019




EU/1/19/1387


Senstend


Iceland


4.12.2019




EU/1/19/1387


Senstend


Norway


4.12.2019




EU/2/19/243


Simparica Trio


Iceland


10.10.2019




EU/2/19/243


Simparica Trio


Liechtenstein


31.10.2019




EU/2/19/243


Simparica Trio


Norway


11.11.2019




EU/1/19/1369


Sixmo


Iceland


17.7.2019




EU/1/19/1369


Sixmo


Norway


15.7.2019




EU/1/19/1410


Spravato


Liechtenstein


31.12.2019




EU/1/19/1372


Striascan


Iceland


2.7.2019




EU/1/19/1372


Striascan


Liechtenstein


31.8.2019




EU/1/19/1372


Striascan


Norway


11.7.2019




EU/1/19/1377


Talzenna


Iceland


16.7.2019




EU/1/19/1377


Talzenna


Norway


15.7.2019




EU/1/19/1359


Trogarzo


Iceland


5.11.2019




EU/1/19/1359


Trogarzo


Liechtenstein


31.10.2019




EU/1/19/1359


Trogarzo


Norway


18.10.2019




EU/1/19/1371


Ultomiris


Iceland


22.7.2019




EU/1/19/1371


Ultomiris


Liechtenstein


31.8.2019




EU/1/19/1371


Ultomiris


Norway


17.7.2019




EU/1/19/1385


VITRAKVI


Iceland


5.11.2019




EU/1/19/1385


VITRAKVI


Liechtenstein


31.10.2019




EU/1/19/1385


VITRAKVI


Norway


18.10.2019




EU/1/18/1312


Xerava


Liechtenstein


31.12.2019




EU/1/19/1399


Xospata


Iceland


6.11.2019




EU/1/19/1399


Xospata


Norway


30.10.2019




EU/1/19/1366


Xromi


Iceland


19.7.2019




EU/1/19/1366


Xromi


Liechtenstein


31.8.2019




EU/1/19/1366


Xromi


Norway


17.7.2019









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 2019:








EU-Number


Product


Country


Date of authorisation




EU/1/14/944


Abasaglar


Iceland


28.8.2019




EU/1/14/944


Abasaglar


Liechtenstein


31.8.2019




EU/1/14/944


Abasaglar


Norway


16.8.2019




EU/1/12/794


ADCETRIS


Iceland


18.10.2019




EU/1/12/794


ADCETRIS


Norway


29.10.2019




EU/1/09/578


Adjupanrix


Iceland


29.8.2019




EU/1/09/578


Adjupanrix


Norway


12.8.2019




EU/1/17/1214


Bavencio


Liechtenstein


31.10.2019




EU/2/14/176


Bovela


Iceland


15.11.2019




EU/2/14/176


Bovela


Liechtenstein


31.12.2019




EU/2/14/176


Bovela


Norway


27.11.2019




EU/1/14/963


Brimica Genuair


Iceland


29.8.2019




EU/1/14/963


Brimica Genuair


Liechtenstein


31.8.2019




EU/1/14/963


Brimica Genuair


Norway


20.09.2019




EU/1/14/951


Busulfan Fresenius Kabi


Norway


15.07.2019




EU/1/14/974


Cerdelga


Iceland


30.12.2019




EU/1/14/974


Cerdelga


Liechtenstein


31.12.2019




EU/1/14/975


Clopidogrel ratiopharm


Iceland


15.11.2019




EU/1/14/975


Clopidogrel ratiopharm


Liechtenstein


31.12.2019




EU/1/14/975


Clopidogrel ratiopharm


Norway


9.12.2019




EU/1/13/890


Cometriq


Norway


3.07.2019




EU/1/14/980


Cosentyx


Iceland


10.9.2019




EU/1/14/980


Cosentyx


Liechtenstein


31.10.2019




EU/1/14/980


Cosentyx


Norway


18.09.2019




EU/1/17/1262


Crysvita


Iceland


27.12.2019




EU/1/17/1262


Crysvita


Liechtenstein


31.12.2019




EU/1/14/957


Cyramza


Iceland


10.10.2019




EU/1/14/957


Cyramza


Norway


3.10.2019




EU/1/14/964


Duaklir Genuair


Iceland


29.8.2019




EU/1/14/964


Duaklir Genuair


Liechtenstein


31.8.2019




EU/1/14/964


Duaklir Genuair


Norway


20.09.2019




EU/1/14/960


DUAVIVE


Iceland


15.11.2019




EU/1/14/960


DUAVIVE


Liechtenstein


31.12.2019




EU/1/14/960


DUAVIVE


Norway


9.12.2019




EU/1/14/972


Duloxetin Lilly


Iceland


28.8.2019




EU/1/14/972


Duloxetin Lilly


Liechtenstein


31.8.2019




EU/1/14/972


Duloxetin Lilly


Norway


30.8.2019




EU/1/14/983


Exviera


Iceland


10.10.2019




EU/1/14/983


Exviera


Norway


18.10.2019




EU/1/09/601


Firdapse


Iceland


30.8.2019




EU/1/09/601


Firdapse


Liechtenstein


31.8.2019




EU/1/09/601


Firdapse


Norway


18.9.2019




EU/1/14/958


Harvoni


Iceland


29.8.2019




EU/1/14/958


Harvoni


Liechtenstein


31.8.2019




EU/1/14/958


Harvoni


Norway


16.8.2019




EU/1/14/945


IMBRUVICA


Iceland


16.7.2019




EU/1/14/945


IMBRUVICA


Liechtenstein


31.8.2019




EU/1/14/945


IMBRUVICA


Norway


2.7.2019




EU/1/09/531


Instanyl


Iceland


23.7.2019




EU/1/09/531


Instanyl


Liechtenstein


31.8.2019




EU/1/09/531


Instanyl


Norway


16.7.2019




EU/1/15/994


Kengrexal


Iceland


27.12.2019




EU/1/15/994


Kengrexal


Liechtenstein


31.12.2019




EU/1/14/965


Ketoconazole HRA


Iceland


5.9.2019




EU/1/14/965


Ketoconazole HRA


Liechtenstein


31.8.2019




EU/1/14/965


Ketoconazole HRA


Norway


12.8.2019




EU/1/14/955


Lymphoseek


Iceland


18.10.2019




EU/1/14/955


Lymphoseek


Norway


25.9.2019




EU/1/14/959


Lynparza


Iceland


10.10.2019




EU/1/14/959


Lynparza


Norway


18.10.2019




EU/1/14/962


Moventig


Iceland


9.10.2019




EU/1/14/962


Moventig


Norway


31.10.2019




EU/1/09/591


Multaq


Iceland


9.10.2019




EU/1/09/591


Multaq


Norway


21.10.2019




EU/2/14/177


Nexgard Spectra


Iceland


15.11.2019




EU/2/14/177


Nexgard Spectra


Liechtenstein


31.12.2019




EU/2/14/177


Nexgard Spectra


Norway


27.11.2019




EU/1/16/1094


Ninlaro


Iceland


18.10.2019




EU/1/14/979


Ofev


Iceland


18.10.2019




EU/1/14/979


Ofev


Norway


21.10.2019




EU/2/14/170


Osurnia


Iceland


22.7.2019




EU/2/14/170


Osurnia


Liechtenstein


31.8.2019




EU/2/14/170


Osurnia


Norway


16.7.2019




EU/1/14/981


Otezla


Iceland


30.8.2019




EU/1/14/981


Otezla


Liechtenstein


31.8.2019




EU/1/14/981


Otezla


Norway


28.9.2019




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Norway


8.7.2019




EU/2/14/175


Porcilis PCV M Hyo


Iceland


9.10.2019




EU/2/14/175


Porcilis PCV M Hyo


Norway


14.10.2019




EU/1/14/977


Rasagiline ratiopharm


Iceland


21.10.2019




EU/1/14/967


Rezolsta


Iceland


28.8.2019




EU/1/14/967


Rezolsta


Liechtenstein


31.8.2019




EU/1/14/967


Rezolsta


Norway


16.8.2019




EU/1/14/970


RIXUBIS


Iceland


5.12.2019




EU/1/15/992


Saxenda


Iceland


27.12.2019




EU/1/15/992


Saxenda


Liechtenstein


31.12.2019




EU/1/14/969


SCENESSE


Iceland


5.12.2019




EU/1/14/969


SCENESSE


Liechtenstein


31.12.2019




EU/1/14/969


SCENESSE


Norway


6.12.2019




EU/1/14/978


Senshio


Iceland


6.11.2019




EU/1/14/978


Senshio


Liechtenstein


31.10.2019




EU/1/14/978


Senshio


Norway


21.11.2019




EU/1/14/952


Sevelamer carbonate Winthrop


Iceland


15.11.2019




EU/1/14/952


Sevelamer carbonate Winthrop


Liechtenstein


31.12.2019




EU/1/14/952


Sevelamer carbonate Winthrop


Norway


27.11.2019




EU/2/14/179


Suvaxyn CSF Marker


Iceland


15.11.2019




EU/2/14/179


Suvaxyn CSF Marker


Liechtenstein


31.12.2019




EU/2/14/179


Suvaxyn CSF Marker


Norway


27.11.2019




EU/1/14/961


Tadalafil Mylan


Iceland


28.8.2019




EU/1/14/961


Tadalafil Mylan


Liechtenstein


31.8.2019




EU/1/14/961


Tadalafil Mylan


Norway


12.8.2019




EU/1/13/902


Translarna


Iceland


28.8.2019




EU/1/13/902


Translarna


Liechtenstein


31.8.2019




EU/1/13/902


Translarna


Norway


26.8.2019




EU/1/14/971


TREVICTA


Iceland


6.12.2019




EU/1/14/971


TREVICTA


Norway


4.12.2019




EU/1/14/940


Triumeq


Iceland


21.10.2019




EU/1/14/940


Triumeq


Norway


16.8.2019




EU/1/14/956


Trulicity


Iceland


29.8.2019




EU/1/14/956


Trulicity


Liechtenstein


31.8.2019




EU/1/14/956


Trulicity


Norway


25.9.2019




EU/1/07/440


Tyverb


Iceland


9.10.2019




EU/1/07/440


Tyverb


Norway


21.10.2019




EU/1/14/954


Vargatef


Iceland


29.8.2019




EU/1/14/954


Vargatef


Liechtenstein


31.8.2019




EU/1/14/954


Vargatef


Norway


2.9.2019




EU/1/07/423


Vectibix


Iceland


9.10.2019




EU/1/07/423


Vectibix


Norway


21.10.2019




EU/1/14/982


Viekirax


Iceland


18.10.2019




EU/1/14/982


Viekirax


Norway


18.10.2019




EU/1/14/941


Vizamyl


Iceland


28.8.2019




EU/1/14/941


Vizamyl


Liechtenstein


31.8.2019




EU/1/14/941


Vizamyl


Norway


12.8.2019




EU/1/14/984


Xadago


Iceland


9.10.2019




EU/1/14/947


Xultophy


Iceland


21.10.2019




EU/1/14/947


Xultophy


Norway


7.8.2019




EU/1/14/986


Xydalba


Iceland


12.12.2019




EU/1/14/986


Xydalba


Liechtenstein


31.12.2019









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 2019:








EU-Number


Product


Country


Date of authorisation




EU/1/13/853/006-014


Remsima


Iceland


5.12.2019




EU/1/15/1043/003-006


Nucala


Iceland


28.8.2019




EU/1/15/1043/003-006


Nucala


Norway


31.7.2019




 


 


 


 




EU/1/17/1216/009


Imraldi


Iceland


30.8.2019




EU/1/17/1220/002


Tecentriq


Iceland


30.8.2019




EU/1/17/1220/002


Tecentriq


Norway


26.8.2019




 


 


 


 




EU/1/12/782/006


Kalydeco


Norway


17.12.2019









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 2019:








EU-Number


Product


Country


Date of withdrawal




EU/1/16/1122


Aerivio Spiromax


Iceland


21.10.2019




EU/1/16/1122


Aerivio Spiromax


Norway


29.10.2019




EU/1/07/390


Altargo


Iceland


28.8.2019




EU/2/99/017


Bovalto Ibraxion


Iceland


16.7.2019




EU/1/14/939


Daklinza


Iceland


13.12.2019




EU/1/15/1077


Iblias


Iceland


10.9.2019




EU/1/15/1077


Iblias


Liechtenstein


31.10.2019




EU/1/15/1077


Iblias


Norway


3.9.2019




EU/2/17/208


Ingelvac PCV FLEX


Norway


23.08.2019




EU/1/19/1357


Kromeya


Liechtenstein


31.12.2019




EU/1/19/1357


Kromeya


Norway


17.12.2019




EU/1/16/1143


Lartruvo


Iceland


26.8.2019




EU/1/16/1143


Lartruvo


Liechtenstein


31.8.2019




EU/1/16/1143


Lartruvo


Norway


5.8.2019




EU/1/13/847


MACI


Iceland


6.11.2019




EU/1/16/1100


Palonosetron Hospira


Iceland


2.7.2019




EU/1/16/1100


Palonosetron Hospira


Norway


23.8.2019




EU/1/13/849


Somatropin Biopartners


Norway


26.8.2019




EU/1/16/1131


Thorinane


Iceland


6.11.2019




EU/1/09/552


Topotecan Teva


Norway


23.08.2019




EU/1/16/1121


Zalmoxis


Iceland


18.10.2019




EU/1/16/1121


Zalmoxis


Norway


30.10.2019









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 2019:








EU-Number


Product


Country


Date of suspension