Medicinal products - List of marketing authorisations granted by the EEA EFTA States for the first half of 2021 2022/C 29/04
Date: 2022-01-20
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_2022029EN.01000701.xml










20.1.2022   


EN


Official Journal of the European Union


C 29/7






Medicinal products - List of marketing authorisations granted by the EEA EFTA States for the first half of 2021
(2022/C 29/04)

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 January – 30 June 2021, at their meeting on 24 September 2021:






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List of withdrawn marketing authorisations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 2021:








EU-Number


Product


Country


Date of authorisation




EU/1/20/1515


Abevmy


Iceland


12.5.2021




EU/1/20/1515


Abevmy


Liechtenstein


30.4.2021




EU/1/20/1515


Abevmy


Norway


28.4.2021




EU/1/20/1512


Abirateron Accord


Liechtenstein


30.4.2021




EU/1/20/1512


Abiraterone Accord


Iceland


14.5.2021




EU/1/20/1512


Abiraterone Accord


Norway


6.5.2021




EU/1/21/1553


Abiraterone Krka


Liechtenstein


30.6.2021




EU/1/21/1553


Abiraterone Krka


Norway


30.6.2021




EU/1/20/1476


Adakveo (conditional)


Liechtenstein


15.1.2021




EU/1/21/1554


Adtralza


Liechtenstein


30.6.2021




EU/1/21/1554


Adtralza


Norway


22.6.2021




EU/1/20/1509


Alymsys


Iceland


14.4.2021




EU/1/20/1509


Alymsys


Liechtenstein


30.4.2021




EU/1/20/1509


Alymsys


Norway


8.4.2021




EU/1/20/1469


Arikayce liposomal


Liechtenstein


15.1.2021




EU/1/20/1475


Arsenic trioxide medac


Liechtenstein


28.2.2021




EU/2/18/228


Arti-Cell Forte


Liechtenstein


28.2.2021




EU/1/20/1473


Ayvakyt


Liechtenstein


28.2.2021




EU/1/18/1339


Bevespi Aerosphere


Liechtenstein


28.2.2021




EU/2/99/017


Bovalto Ibraxion


Liechtenstein


28.2.2021




EU/1/21/1534


BroPair Spiromax


Iceland


14.4.2021




EU/1/21/1534


BroPair Spiromax


Liechtenstein


30.4.2021




EU/1/21/1534


BroPair Spiromax


Norway


8.4.2021




EU/2/10/112


BTVPUR AlSap 1


Liechtenstein


28.2.2021




EU/2/09/094


BTVPUR AlSap 8


Liechtenstein


28.2.2021




EU/1/20/1505


Byfavo


Iceland


26.4.2021




EU/1/20/1505


Byfavo


Norway


8.4.2021




EU/1/20/1505


Byvafo


Liechtenstein


30.4.2021




EU/120/1448


Cabazitaxel Accord


Liechtenstein


28.2.2021




EU/1/20/1479


Calquence


Liechtenstein


15.1.2021




EU/1/21/1560


Celsunax


Liechtenstein


30.6.2021




EU/1/21/1560


Celsunax


Norway


23.6.2021




EU/2/20/264


CircoMax Myco


Iceland


4.1.2021




EU/2/20/264


CircoMax Myco


Liechtenstein


15.1.2021




EU/1/19/1395


Clopidogrel/Acetylsalicylic acid Mylan


Liechtenstein


28.2.2021




EU/1/20/1528


Comirnaty (conditional)


Liechtenstein


15.1.2021




EU/1/21/1542


Copiktra


Iceland


9.6.2021




EU/1/21/1542


Copiktra


Liechtenstein


30.6.2021




EU/1/21/1542


Copiktra


Norway


3.6.2021




EU/2/18/230


Cortacare


Liechtenstein


28.2.2021




EU/1/21/1529


COVID-19 Vaccine AstraZeneca


Iceland


29.1.2021




EU/1/21/1529


COVID-19 Vaccine AstraZeneca


Liechtenstein


28.2.2021




EU/1/20/1529


COVID-19 Vaccine AstraZeneca (Vaxzevria)


Norway


29.1.2021




EU/1/20/1525


COVID-19 Vaccine Janssen


Iceland


11.3.2021




EU/1/20/1525


COVID-19 Vaccine Janssen


Liechtenstein


30.4.2021




EU/1/20/1525


COVID-19 Vaccine Janssen


Norway


11.3.2021




EU/1/20/1507


COVID-19 Vaccine Moderna


Iceland


6.1.2021




EU/1/20/1507


COVID-19 Vaccine Moderna (conditional)


Liechtenstein


15.1.2021




EU/1/20/1507


COVID-19 Vaccine Moderna (Spikevax)


Norway


6.1.2021




EU/2/21/271


Credelio Plus


Iceland


26.4.2021




EU/2/21/271


Credelio Plus


Liechtenstein


30.4.2021




EU/2/21/271


Credelio Plus


Norway


19.4.2021




EU/1/17/1248


Darunavir Krka d.d.


Liechtenstein


28.2.2021




EU/2/21/270


Daxocox


Iceland


14.5.2021




EU/2/21/270


Daxocox


Liechtenstein


30.4.2021




EU/2/21/270


Daxocox


Norway


3.6.2021




EU/1/19/1412


Deferasirox Accord


Liechtenstein


28.2.2021




EU/1/21/1547


Drovelis


Iceland


8.6.2021




EU/1/21/1547


Drovelis


Liechtenstein


30.6.2021




EU/1/21/1547


Drovelis


Norway


3.6.2021




EU/1/18/1284


Dzuveo


Liechtenstein


28.2.2021




EU/1/21/1549


Efmody


Iceland


10.6.2021




EU/1/21/1549


Efmody


Liechtenstein


30.4.2021




EU/1/21/1549


Efmody


Norway


10.6.2021




EU/1/20/1504


Elzonris


Iceland


19.1.2021




EU/1/20/1504


Elzonris


Liechtenstein


28.2.2021




EU/1/20/1504


Elzonris


Norway


18.1.2021




EU/1/18/1330


Emgality


Liechtenstein


28.2.2021




EU/1/20/1438


Enerzair Breezhaler


Liechtenstein


28.2.2021




EU/1/20/1508


Enhertu


Iceland


28.1.2021




EU/1/20/1508


Enhertu


Liechtenstein


28.2.2021




EU/1/20/1508


Enhertu


Norway


26.1.2021




EU/1/21/1559


Enspryng


Liechtenstein


30.6.2021




EU/2/20/268


Enteroporc Coli


Iceland


21.1.2021




EU/2/20/268


Enteroporc Coli


Liechtenstein


15.1.2021




EU/2/20/268


Enteroporc Coli


Norway


3.6.2021




EU/2/20/262


Enteroporc Coli AC


Iceland


8.1.2021




EU/2/20/262


Enteroporc Coli AC


Liechtenstein


15.1.2021




EU/1/20/1472


Equidacent


Liechtenstein


15.1.2021




EU/1/19/1392


Ervebo


Liechtenstein


28.2.2021




EU/1/12/750


Esmya


Iceland


1.2.2021




EU/1/21/1551


Evkeeza


Liechtenstein


30.6.2021




EU/1/21/1551


Evkeeza


Norway


30.6.2021




EU/1/21/1531


Evrysdi


Iceland


14.4.2021




EU/1/21/1531


Evrysdi


Liechtenstein


30.4.2021




EU/1/21/1531


Evrysdi


Norway


8.4.2021




EU/1/20/1489


Exparel liposomal


Liechtenstein


28.2.2021




EU/1/20/1477


Fampridine Accord


Liechtenstein


15.1.2021




EU/1/20/1491


Fintepla


Iceland


22.1.2021




EU/1/20/1491


Fintepla


Liechtenstein


15.1.2021




EU/1/20/1491


Fintepla


Norway


15.1.2021




EU/1/18/1326


Flucelvax Tetra


Liechtenstein


28.2.2021




EU/1/19/1375


Grasustek


Liechtenstein


28.2.2021




EU/1/20/1503


Heplisav B


Iceland


22.2.2021




EU/1/20/1503


Heplisav B


Liechtenstein


28.2.2021




EU/1/20/1503


Heplisav B


Norway


25.2.2021




EU/2/20/258


Increxxa


Liechtenstein


28.2.2021




EU/2/20/258


Increxxa


Norway


22.2.2021




EU/2/17/208


Ingelvac PCV FLEX


Liechtenstein


28.2.2021




EU/2/17/213


Innovax-ND-IBD


Liechtenstein


28.2.2021




EU/2/20/256


Innovax-ND-ILT


Liechtenstein


15.1.2021




EU/2/20/256


Innovax-ND-ILT


Norway


4.1.2021




EU/1/20/1514


Inrebic


Iceland


19.2.2021




EU/1/20/1514


Inrebic


Liechtenstein


28.2.2021




EU/1/20/1514


Inrebic


Norway


11.2.2021




EU/2/18/232


Isemid


Liechtenstein


28.2.2021




EU/1/19/1396


Ivozall


Liechtenstein


28.2.2021




EU/1/21/1557


Jayempi


Liechtenstein


30.6.2021




EU/1/21/1557


Jayempi


Norway


30.6.2021




EU/1/21/1538


Jemperli


Iceland


12.5.2021




EU/1/21/1538


Jemperli


Liechtenstein


30.4.2021




EU/1/21/1538


Jemperli


Norway


28.4.2021




EU/1/20/1480


Jyseleca


Liechtenstein


15.1.2021




EU/1/21/1532


Kesimpta


Iceland


15.4.2021




EU/1/21/1532


Kesimpta


Liechtenstein


30.4.2021




EU/1/21/1532


Kesimpta


Norway


8.4.2021




EU/1/20/1506


Kixelle


Iceland


18.2.2021




EU/1/20/1506


Kixelle


Liechtenstein


28.2.2021




EU/1/20/1506


Kixelle


Norway


11.2.2021




EU/1/21/1552


Koselugo


Liechtenstein


30.6.2021




EU/1/21/1552


Koselugo


Norway


22.6.2021




EU/1/20/1520


Lenalidomide Krka


Iceland


4.3.2021




EU/1/20/1520


Lenalidomide Krka


Liechtenstein


28.2.2021




EU/1/20/1520


Lenalidomide Krka


Norway


21.6.2021




EU/1/20/1521


Lenalidomide Krka d.d.


Iceland


5.3.2021




EU/1/20/1521


Lenalidomide Krka d.d.


Liechtenstein


30.4.2021




EU/1/20/1521


Lenalidomide Krka d.d.


Norway


16.6.2021




EU/1/20/1519


Lenalidomide Krka d.d. Novo mesto


Iceland


24.2.2021




EU/1/20/1519


Lenalidomide Krka d.d. Novo mesto


Liechtenstein


28.2.2021




EU/1/20/1519


Lenalidomide Krka d.d. Novo mesto


Norway


18.6.2021




EU/1/20/1490


Lenalidomide Mylan


Iceland


11.1.2021




EU/1/20/1490


Lenalidomide Mylan


Liechtenstein


28.2.2021




EU/1/20/1494


Leqvio


Iceland


5.1.2021




EU/1/20/1494


Leqvio


Liechtenstein


15.1.2021




EU/1/20/1516


Lextemy


Iceland


12.5.2021




EU/1/20/1516


Lextemy


Liechtenstein


30.4.2021




EU/1/20/1516


Lextemy


Norway


28.4.2021




EU/1/20/1493


Libmeldy


Iceland


14.1.2021




EU/1/20/1493


Libmeldy


Liechtenstein


15.1.2021




EU/1/20/1493


Libmeldy


Norway


8.1.2021




EU/2/20/261


Librela


Liechtenstein


15.1.2021




EU/2/20/261


Librela


Norway


4.1.2021




EU/1/20/1470


Lumeblue


Liechtenstein


28.2.2021




EU/1/20/1522


Lumoxiti


Iceland


19.2.2021




EU/1/20/1522


Lumoxiti


Liechtenstein


28.2.2021




EU/1/20/1522


Lumoxiti


Norway


11.2.2021




EU/1/21/1548


Lydisilka


Iceland


8.6.2021




EU/1/21/1548


Lydisilka


Liechtenstein


30.6.2021




EU/1/21/1548


Lydisilka


Norway


31.5.2021




EU/1/20/1483


MenQuadfi


Liechtenstein


15.1.2021




EU/2/20/259


Mhyosphere PCV ID


Liechtenstein


28.2.2021




EU/2/20/259


Mhyosphere PCV ID


Norway


4.1.2021




EU/1/20/1445


Mvabea


Liechtenstein


28.2.2021




EU/1/18/1325


Namuscla


Liechtenstein


28.2.2021




EU/2/20/267


NexGard Combo


Iceland


25.1.2021




EU/2/20/267


NexGard Combo


Liechtenstein


28.2.2021




EU/2/20/267


NexGard Combo


Norway


20.1.2021




EU/1/21/1537


Nexpovio


Iceland


30.3.2021




EU/1/21/1537


Nexpovio


Liechtenstein


30.4.2021




EU/1/21/1537


Nexpovio


Norway


8.4.2021




EU/1/18/1290


Nityr


Liechtenstein


28.2.2021




EU/2/20/265


Nobivac DP Plus


Iceland


4.1.2021




EU/2/20/265


Nobivac DP Plus


Liechtenstein


15.1.2021




EU/1/19/1364


Nuceiva


Liechtenstein


28.2.2021




EU/1/20/1486


Nyvepria


Liechtenstein


15.1.2021




EU/1/20/1485


Obiltoxaximab SFL (exceptional circumstances)


Liechtenstein


15.1.2021




EU/1/20/1523


Ogluo


Iceland


22.2.2021




EU/1/20/1523


Ogluo


Liechtenstein


28.2.2021




EU/1/20/1523


Ogluo


Norway


23.2.2021




EU/1/20/1499


Onbevzi


Iceland


19.1.2021




EU/1/20/1499


Onbevzi


Liechtenstein


28.2.2021




EU/1/20/1499


Onbevzi


Norway


15.1.2021




EU/1/21/1530


Ontozry


Iceland


15.4.2021




EU/1/21/1530


Ontozry


Liechtenstein


30.4.2021




EU/1/21/1530


Ontozry


Norway


9.4.2021




EU/1/21/1556


Onureg


Liechtenstein


30.6.2021




EU/1/21/1556


Onureg


Norway


22.6.2021




EU/1/21/1544


Orladeyo


Iceland


14.5.2021




EU/1/21/1544


Orladeyo


Liechtenstein


30.6.2021




EU/1/21/1544


Orladeyo


Norway


6.5.2021




EU2/20/260


OvuGel


Liechtenstein


28.2.2021




EU/2/20/260


OvuGel


Norway


4.1.2021




EU/1/20/1496


Oxlumo


Liechtenstein


15.1.2021




EU/1/20/1510


Oyavas


Iceland


14.4.2021




EU/1/20/1510


Oyavas


Liechtenstein


30.4.2021




EU/1/20/1510


Oyavas


Norway


8.4.2021




EU/1/20/1495


Palforzia


Iceland


18.1.2021




EU/1/20/1495


Palforzia


Liechtenstein


28.2.2021




EU/1/20/1495


Palforzia


Norway


15.1.2021




EU/1/21/1535


Pemazyre


Iceland


30.3.2021




EU/1/21/1535


Pemazyre


Liechtenstein


30.4.2021




EU/1/21/1535


Pemazyre


Norway


8.4.2021




EU/1/20/1487


Phelinun


Liechtenstein


28.2.2021




EU/1/20/1497


Phesgo


Iceland


11.1.2021




EU/1/20/1497


Phesgo


Liechtenstein


15.1.2021




EU/1/21/1550


Ponvory


Iceland


9.6.2021




EU/1/21/1550


Ponvory


Liechtenstein


30.6.2021




EU/1/21/1550


Ponvory


Norway


4.6.2021




EU/2/20/254


Prevexxion RN


Liechtenstein


28.2.2021




EU/2/20/255


Prevexxion RN+HVT+IBD


Norway


4.1.2021




EU/2/17/211


Prevomax


Liechtenstein


28.2.2021




EU/1/20/1482


Rekambys


Iceland


11.1.2021




EU/1/20/1482


Rekambys


Liechtenstein


15.1.2021




EU/1/20/1482


Rekambys


Norway


5.1.2021




EU/1/20/1527


Retsevmo


Iceland


19.2.2021




EU/1/20/1527


Retsevmo


Liechtenstein


28.2.2021




EU/1/20/1527


Retsevmo


Norway


11.2.2021




EU/2/20/263


Rexxolide


Iceland


4.1.2021




EU/2/20/263


Rexxolide


Liechtenstein


28.2.2021




EU/1/19/1400


Rhokiinsa


Liechtenstein


28.2.2021




EU/1/20/1488


Rivaroxaban Accord


Liechtenstein


15.1.2021




EU/1/20/1502


Roclanda


Iceland


12.1.2021




EU/1/20/1502


Roclanda


Liechtenstein


28.2.2021




EU/1/20/1502


Roclanda


Norway


14.1.2021




EU/1/20/1460


Rozlytrek


Liechtenstein


28.2.2021




EU/1/20/1518


Rukobia


Iceland


19.2.2021




EU/1/20/1518


Rukobia


Liechtenstein


28.2.2021




EU/1/20/1518


Rukobia


Norway


11.2.2021




EU/1/20/1431


Ruxience


Liechtenstein


28.2.2021




EU/1/20/1435


Sarclisa


Liechtenstein


28.2.2021




EU/1/21/1533


Seffalair Spiromax


Iceland


14.4.2021




EU/1/21/1533


Seffalair Spiromax


Liechtenstein


30.4.2021




EU/1/21/1533


Seffalair Spiromax


Norway


8.4.2021




EU/1/20/1517


Sibnayal


Iceland


14.5.2021




EU/1/20/1517


Sibnayal


Liechtenstein


30.6.2021




EU/1/20/1517


Sibnayal


Norway


5.5.2021




EU/1/20/1501


Sogroya


Iceland


15.4.2021




EU/1/20/1501


Sogroya


Liechtenstein


30.4.2021




EU/1/20/1501


Sogroya


Norway


8.4.2021




EU/2/20/269


Solensia


Liechtenstein


28.2.2021




EU/2/20/269


Solensia


Norway


14.6.2021




EU/1/19/1421


Staquis


Liechtenstein


28.2.2021




EU/1/20/1511


Sunitinib Accord


Iceland


4.3.2021




EU/1/20/1511


Sunitinib Accord


Liechtenstein


30.4.2021




EU/1/20/1511


Sunitinib Accord


Norway


5.3.2021




EU/1/20/1484


Supemtek


Liechtenstein


15.1.2021




EU2/09/099


Suvaxyn PCV


Liechtenstein


28.2.2021




EU/2/18/231


Syvazul BTV


Liechtenstein


28.2.2021




EU/1/20/1492


Tecartus


Iceland


8.1.2021




EU/1/20/1492


Tecartus (conditional)


Liechtenstein


15.1.2021




EU/1/19/1378


Temybric Ellipta


Liechtenstein


28.2.2021




EU/1/21/1536


Thiotepa Riemser


Iceland


15.4.2021




EU/1/21/1536


Thiotepa Riemser


Liechtenstein


30.4.2021




EU/1/21/1536


Thiotepa Riemser


Norway


8.4.2021




EU/1/18/1351


Trecondi


Liechtenstein


15.1.2021




EU/1/19/1419


Trepulmix


Liechtenstein


28.2.2021




EU/1/20/1498


Trixeo Aerosphere


Iceland


8.1.2021




EU/1/20/1498


Trixeo Aerosphere


Liechtenstein


28.2.2021




EU/1/20/1526


Tukysa


Iceland


19.2.2021




EU/1/20/1526


Tukysa


Liechtenstein


28.2.2021




EU/1/20/1526


Tukysa


Norway


25.2.2021




EU/2/20/257


Tulinovet


Liechtenstein


15.1.2021




EU/2/20/252


Tulissin


Liechtenstein


28.2.2021




EU/2/21/272


Ultifend ND IBD


Iceland


12.5.2021




EU/2/21/272


Ultifend ND IBD


Liechtenstein


30.4.2021




EU/2/21/272


Ultifend ND IBD


Norway


29.4.2021




EU/1/20/1524


Vazkepa


Iceland


30.3.2021




EU/1/20/1524


Vazkepa


Liechtenstein


30.4.2021




EU/1/20/1524


Vazkepa


Norway


8.4.2021




EU/2/20/266


Vectormune FP ILT


Iceland


5.1.2021




EU/2/20/266


Vectormune FP ILT


Liechtenstein


15.1.2021




EU/2/20/266


Vectormune FP ILT


Norway


4.1.2021




EU/1/18/1298


Veyvondi


Liechtenstein


28.2.2021




EU/1/20/1481


Vocabria


Iceland


26.1.2021




EU/1/20/1481


Vocabria


Liechtenstein


28.2.2021




EU/1/20/1500


Xofluza


Iceland


12.1.2021




EU/1/20/1500


Xofluza


Liechtenstein


28.2.2021




EU/1/20/1500


Xofluza


Norway


14.1.2021




EU/1/20/1513


Yuflyma


Iceland


24.2.2021




EU/1/20/1513


Yuflyma


Liechtenstein


28.2.2021




EU/1/20/1513


Yuflyma


Norway


25.2.2021




EU/2/17/210


Zeleris


Liechtenstein


28.2.2021




EU/2/09/186


Zulvac 8 Bovis


Liechtenstein


28.2.2021




EU/2/17/207


Zulvac BTV Ovis


Liechtenstein


28.2.2021




EU/1/20/1478


Zynrelef


Liechtenstein


15.1.2021









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 2021:








EU-Number


Product


Country


Date of authorisation




EU/1/12/794


ADCETRIS


Liechtenstein


15.1.2021




EU/1/16/1098


Alprolix


Iceland


25.2.2021




EU/1/16/1098


Alprolix


Liechtenstein


30.4.2021




EU/1/16/1098


Alprolix


Norway


23.3.2021




EU/1/16/1092


Amlodipine/Valsartan Mylan


Iceland


25.1.2021




EU/1/16/1092


Amlodipine/Valsartan Mylan


Liechtenstein


28.2.2021




EU/1/15/1045


Aripiprazole Accord


Liechtenstein


15.1.2021




EU/1/16/1091


Atazanavir Mylan


Iceland


17.5.2021




EU/1/16/1091


Atazanavir Mylan


Liechtenstein


30.4.2021




EU/1/16/1091


Atazanavir Mylan


Norway


3.5.2021




EU/1/15/1074


Benepali


Liechtenstein


15.1.2021




EU/1/20/1474


Blenrep


Liechtenstein


30.6.2021




EU/1/16/1114


Bortezomib Hospira


Iceland


17.5.2021




EU/1/16/1114


Bortezomib Hospira


Liechtenstein


30.6.2021




EU/1/16/1114


Bortezomib Hospira


Norway


7.5.2021




EU/1/16/1102


Bortezomib SUN


Liechtenstein


30.6.2021




EU/1/16/1102


Bortezomib SUN


Norway


30.6.2021




EU/1/13/818


Bosulif


Iceland


22.2.2021




EU/1/13/818


Bosulif


Norway


8.3.2021




EU/1/13/818


Bosulif


Liechtenstein


28.2.2021




EU/1/15/1073


Briviact


Liechtenstein


15.1.2021




EU/1/16/1136


Cabometyx


Iceland


12.5.2021




EU/1/16/1136


Cabometyx


Liechtenstein


30.4.2021




EU/1/16/1136


Cabometyx


Norway


3.5.2021




EU/1/11/749


Caprelsa


Iceland


15.1.2021




EU/1/11/749


Caprelsa


Norway


3.2.2021




EU/1/11/749


Caprelsa


Liechtenstein


28.2.2021




EU/1/15/1055


Ciambra


Liechtenstein


28.2.2021




EU/1/15/1054


Cinacalcet Mylan


Liechtenstein


15.1.2021




EU/1/16/1125


Cinqaero


Iceland


10.6.2021




EU/1/16/1125


Cinqaero


Liechtenstein


30.6.2021




EU/1/16/1125


Cinqaero


Norway


10.6.2021




EU/1/16/1087


Coagadex


Iceland


14.4.2021




EU/1/16/1087


Coagadex


Liechtenstein


30.4.2021




EU/1/16/1087


Coagadex


Norway


7.4.2021




EU/1/13/890


Cometriq


Iceland


11.3.2021




EU/1/13/890


Cometriq


Liechtenstein


28.2.2021




EU/1/17/1262


Crysvita


Iceland


2.2.2021




EU/1/17/1262


Crysvita


Liechtenstein


28.2.2021




EU/1/17/1262


Crysvita


Norway


2.2.2021




EU/1/13/875


Deltyba


Iceland


26.4.2021




EU/1/13/875


Deltyba


Liechtenstein


30.4.2021




EU/1/16/1099


Descovy


Iceland


10.3.2021




EU/1/16/1099


Descovy


Liechtenstein


28.2.2021




EU/1/16/1099


Descovy


Norway


15.3.2021




EU/1/15/1051


Ebymect


Liechtenstein


28.2.2021




EU/1/15/1052


Edistride


Liechtenstein


28.2.2021




EU/1/11/691


Eliquis


Iceland


19.1.2021




EU/1/11/691


Eliquis


Liechtenstein


28.2.2021




EU/1/11/691


Eliquis


Norway


18.1.2021




EU/1/15/1046


Elocta


Norway


22.2.2021




EU/1/16/1088


Empliciti


Iceland


13.1.2021




EU/1/16/1088


Empliciti


Liechtenstein


15.1.2021




EU/1/16/1105


EndolucinBeta


Iceland


18.2.2021




EU/1/16/1105


EndolucinBeta


Liechtenstein


28.2.2021




EU/1/16/1105


EndolucinBeta


Norway


16.2.2021




EU/1/16/1116


Epclusa


Iceland


25.3.2021




EU/1/16/1116


Epclusa


Liechtenstein


30.4.2021




EU/1/16/1116


Epclusa


Norway


25.3.2021




EU/1/15/1069


Episalvan


Liechtenstein


15.1.2021




EU/1/15/1065


Eptifibatid Accord


Liechtenstein


15.1.2021




EU/1/19/1392


Ervebo


Norway


3.2.2021




EU/1/19/1392


Ervebo-Ebola Zaire-Impfstoff


Liechtenstein


15.1.2021




EU/2/16/194


Evalon


Iceland


24.2.2021




EU/2/16/194


Evalon


Liechtenstein


28.2.2021




EU/2/16/194


Evalon


Norway


26.2.2021




EU/1/15/1075


Feraccru


Liechtenstein


15.1.2021




EU/1/16/1106


Flixabi


Iceland


10.3.2021




EU/1/16/1106


Flixabi


Liechtenstein


30.4.2021




EU/1/16/1106


Flixabi


Norway


7.4.2021




EU/1/15/1082


Galafold


Iceland


25.2.2021




EU/1/15/1082


Galafold


Liechtenstein


28.2.2021




EU/1/15/1082


Galafold


Norway


23.2.2021




EU/1/15/1061


Genvoya


Liechtenstein


28.2.2021




EU/1/11/677


Gilenya


Liechtenstein


15.1.2021




EU/1/15/1008


Hetlioz


Liechtenstein


28.2.2021




EU/1/14/987


Holoclar


Iceland


25.1.2021




EU/1/14/987


Holoclar


Liechtenstein


28.2.2021




EU/1/16/1095


Idelvion


Iceland


18.2.2021




EU/1/16/1095


Idelvion


Liechtenstein


28.2.2021




EU/1/16/1095


Idelvion


Norway


11.2.2021




EU/1/15/1064


Imlygic


Liechtenstein


15.1.2021




EU/2/15/193


Imrestor


Liechtenstein


15.1.2021




EU/1/11/676


Jevtana


Iceland


8.1.2021




EU/1/11/676


Jevtana


Liechtenstein


15.1.2021




EU/1/16/1128


Kisplyx


Liechtenstein


30.6.2021




EU/1/16/1128


Kisplyx


Norway


22.6.2021




EU/1/15/1076


Kovaltry


Liechtenstein


15.1.2021




EU/2/16/195


Letifend


Iceland


24.2.2021




EU/2/16/195


Letifend


Liechtenstein


28.2.2021




EU/2/16/195


Letifend


Norway


5.3.2021




EU/1/19/1376


Libtayo


Liechtenstein


30.6.2021




EU/1/19/1376


Libtayo


Iceland


21.5.2021




EU/1/19/1376


Libtayo


Norway


21.5.2021




EU/1/16/1096


Lonsurf


Iceland


8.1.2021




EU/1/16/1096


Lonsurf


Liechtenstein


15.1.2021




EU/1/16/1096


Lonsurf


Norway


8.1.2021




EU/1/15/1067


Lopinavir/Ritonavir Mylan


Liechtenstein


15.1.2021




EU/1/19/1355


Lorviqua


Iceland


26.4.2021




EU/1/19/1355


Lorviqua


Liechtenstein


30.4.2021




EU/1/19/1355


Lorviqua


Norway


8.4.2021




EU/1/15/1078


Natpar


Iceland


27.4.2021




EU/1/15/1078


Natpar


Liechtenstein


30.4.2021




EU/1/15/1078


Natpar


Norway


26.4.2021




EU/1/15/1053


Neofordex


Iceland


15.1.2021




EU/1/15/1053


Neofordex


Liechtenstein


15.1.2021




EU/1/15/1053


Neofordex


Norway


31.1.2021




EU/1/16/1103


Neparvis


Iceland


22.2.2021




EU/1/16/1103


Neparvis


Liechtenstein


28.2.2021




EU/1/16/1103


Neparvis


Norway


16.2.2021




EU/1/16/1094


Ninlaro


Liechtenstein


15.1.2021




EU/1/16/1094


Ninlaro


Norway


22.2.2021




EU/1/16/1124


Nordimet


Liechtenstein


30.6.2021




EU/1/16/1124


Nordimet


Norway


25.6.2021




EU/1/15/1035


Obizur


Liechtenstein


28.2.2021




EU/1/16/1139


Ocaliva


Iceland


25.1.2021




EU/1/16/1139


Ocaliva


Norway


3.2.2021




EU/1/16/1139


Ocaliva


Liechtenstein


28.2.2021




EU/1/16/1112


Odefsey


Iceland


19.1.2021




EU/1/16/1112


Odefsey


Liechtenstein


28.2.2021




EU/1/16/1112


Odefsey


Norway


14.1.2021




EU/1/15/1070


Oncaspar


Liechtenstein


15.1.2021




EU/1/18/1345


Ondexxya


Iceland


2.3.2021




EU/1/18/1345


Ondexxya


Liechtenstein


28.2.2021




EU/1/18/1345


Ondexxya


Norway


8.3.2021




EU/1/15/1066


Ongentys


Iceland


15.3.2021




EU/1/15/1066


Ongentys


Liechtenstein


28.2.2021




EU/1/15/1066


Ongentys


Norway


15.3.2021




EU/1/15/1059


Orkambi


Liechtenstein


15.1.2021




EU/1/16/1104


Palonosetron Accord


Iceland


22.2.2021




EU/1/16/1104


Palonosetron Accord


Liechtenstein


28.2.2021




EU/1/16/1104


Palonosetron Accord


Norway


26.2.2021




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Iceland


16.3.2021




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Liechtenstein


30.4.2021




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Norway


24.3.2021




EU/1/15/1071


Pemetrexed Accord


Liechtenstein


28.2.2021




EU/1/16/1115


Pemetrexed Fresenius Kabi


Iceland


12.5.2021




EU/1/16/1115


Pemetrexed Fresenius Kabi


Liechtenstein


30.4.2021




EU/1/16/1115


Pemetrexed Fresenius Kabi


Norway


20.5.2021




EU/1/15/1057


Pemetrexed Hospira


Liechtenstein


28.2.2021




EU/1/19/1388


Polivy


Iceland


5.1.2021




EU/1/19/1388


Polivy


Liechtenstein


15.1.2021




EU/1/16/1108


Qtern


Iceland


9.6.2021




EU/1/16/1108


Qtern


Liechtenstein


30.4.2021




EU/1/16/1108


Qtern


Norway


3.6.2021




EU/1/16/1090


Rasagiline Mylan


Liechtenstein


15.1.2021




EU/1/20/1460


Rozlytrek


Liechtenstein


30.6.2021




EU/1/17/1250


Rubraca


Iceland


15.3.2021




EU/1/17/1250


Rubraca


Liechtenstein


30.4.2021




EU/1/17/1250


Rubraca


Norway


11.3.2021




EU/2/16/196


Sevohale


Iceland


14.5.2021




EU/2/16/196


Sevohale


Liechtenstein


30.4.2021




EU/2/16/196


Sevohale


Norway


7.5.2021




EU/1/16/1135


Sialanar


Liechtenstein


30.6.2021




EU/1/16/1135


Sialanar


Norway


30.6.2021




EU/1/13/901


Sirturo


Iceland


14.1.2021




EU/1/13/901


Sirturo


Liechtenstein


28.2.2021




EU/1/13/901


Sirturo


Norway


8.2.2021




EU/1/15/1072


Spectrila


Liechtenstein


15.1.2021




EU/1/16/1097


Strimvelis


Iceland


14.5.2021




EU/1/16/1097


Strimvelis


Liechtenstein


30.6.2021




EU/1/16/1097


Strimvelis


Norway


7.5.2021




EU/1/15/1085


Taltz


Iceland


29.1.2021




EU/1/15/1085


Taltz


Liechtenstein


15.1.2021




EU/1/15/1085


Taltz


Norway


14.1.2021




EU/1/13/902


Translarna


Liechtenstein


28.2.2021




EU/1/15/1083


Uptravi


Iceland


8.1.2021




EU/1/15/1083


Uptravi


Liechtenstein


15.1.2021




EU/1/15/1079


Vaxelis


Liechtenstein


15.1.2021




EU/2/15/188


Vectormune ND


Iceland


18.2.2021




EU/2/15/188


Vectormune ND


Liechtenstein


28.2.2021




EU/1/20/1459


Veklury


Liechtenstein


30.6.2021




EU/1/15/1068


Wakix


Iceland


29.1.2021




EU/1/15/1068


Wakix


Liechtenstein


28.2.2021




EU/1/19/1360


Waylivra


Iceland


18.2.2021




EU/1/19/1360


Waylivra


Norway


1.3.2021




EU/1/19/1360


Waylivra


Liechtenstein


28.2.2021




EU/1/15/1042


Zalviso


Liechtenstein


15.1.2021




EU/1/16/1109


Zavicefta


Iceland


24.2.2021




EU/1/16/1109


Zavicefta


Liechtenstein


28.2.2021




EU/1/16/1109


Zavicefta


Norway


26.2.2021




EU/1/16/1119


Zepatier


Iceland


14.5.2021




EU/1/16/1119


Zepatier


Liechtenstein


30.6.2021




EU/1/16/1119


Zepatier


Norway


18.5.2021




EU/1/11/690


Zoely


Iceland


25.5.2021




EU/1/11/690


Zoely


Liechtenstein


30.6.2021




EU/1/11/690


Zoely


Norway


31.5.2021




EU/1/20/1443


Zolgensma


Iceland


8.6.2021




EU/1/20/1443


Zolgensma


Liechtenstein


30.6.2021




EU/1/20/1443


Zolgensma


Norway


2.6.2021




EU/1/16/1093


Zonisamide Mylan


Iceland


4.1.2021




EU/1/16/1093


Zonisamide Mylan


Liechtenstein


28.2.2021









ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January – 30 June 2021:








EU-Number


Product


Country


Date of authorisation




EU/1/13/838/006


Aubagio


Norway


22.6.2021




EU/1/18/1336/009


Buvidal


Iceland


16.6.2021




EU/1/18/1336/009


Buvidal


Norway


3.6.2021




EU/1/06/367/013


Diacomit


Iceland


10.6.2021




EU/1/06/367/013


Diacomit


Norway


10.6.2021




EU/2/11/128/004-010


Emdocam


Iceland


25.5.2021




EU/1/18/1319/009-010


Hulio


Iceland


18.1.2021




EU/1/18/1319/009-010


Hulio


Norway


18.1.2021




EU/1/20/1447/006-007


Insulin Aspart Sanofi


Iceland


14.5.2021




EU/1/20/1447/006-007


Insulin Aspart Sanofi


Norway


4.5.2021




EU/1/19/1364/002


Nuceiva


Iceland


29.1.2021




EU/1/19/1364/002


Nuceiva


Norway


27.1.2021




EU/1/14/934/007-008


Plegridy


Iceland


8.1.2021




EU/1/08/442/025-031


Pradaxa


Iceland


21.1.2021




EU/1/08/442/025-031


Pradaxa


Norway


19.1.2021




EU/1/13/901/003


Sirturo


Iceland


15.4.2021




EU/1/13/901/003


Sirturo


Norway


8.4.2021




EU/1/19/1361/002-003


Skyrizi


Iceland


10.6.2021




EU/1/19/1361/002-003


Skyrizi


Norway


4.6.2021




EU/1/10/622/003


Tepadina


Iceland


15.4.2021




EU/1/10/622/003


Tepadina


Norway


19.4.2021




EU/1/13/892/007


Tivicay


Iceland


25.1.2021




EU/1/13/892/007


Tivicay


Norway


18.1.2021




EU/1/17/1208/006-009


Trimbow


Iceland


29.1.2021




EU/1/17/1208/010-012


Trimbow


Iceland


26.4.2021




EU/1/17/1208/006-009


Trimbow


Norway


26.1.2021




EU/1/17/1208/010-012


Trimbow


Norway


12.4.2021




EU/1/06/346/002


Tysabri


Iceland


15.4.2021




EU/1/06/346/002


Tysabri


Norway


8.4.2021




EU/1/08/472/050-051


Xarelto


Iceland


1.2.2021




EU/1/17/472/050-051


Xarelto


Norway


26.1.2021




EU/1/18/1312/003-004


Xerava


Iceland


2.3.2021




EU/1/18/1312/003-004


Xerava


Norway


5.3.2021









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 2021:








EU-Number


Product


Country


Date of withdrawal




EU/2/08/088


Acticam


Iceland


26.3.2021




EU/2/08/088


Acticam


Liechtenstein


30.4.2021




EU/2/08/088


Acticam


Norway


26.3.2021




EU/1/16/1122


Aerivio Spiromax


Liechtenstein


28.2.2021




EU/1/16/1123


Airexar Spiromax


Liechtenstein


28.2.2021




EU/1/18/1269


Alpivab


Liechtenstein


15.1.2021




EU/1/07/390


Altargo


Liechtenstein


28.2.2021




EU/1/10/625


Arzerra


Liechtenstein


28.2.2021




EU/1/06/355


ATryn


Liechtenstein


28.2.2021




EU/1/19/1382


Azacitidin Celgene


Liechtenstein


30.6.2021




EU/1/19/1382


Azacitidine Celgene


Iceland


25.5.2021




EU/1/19/1382


Azacitidine Celgene


Norway


16.6.2021




EU/1/15/1081


Caspofungin Accord


Iceland


25.2.2021




EU/1/15/1081


Caspofungin Accord


Liechtenstein


28.2.2021




EU/1/10/623


Clopidogrel/Acetylsalicylic acid Zentiva


Liechtenstein


28.2.2021




EU/1/10/623


Clopidogrel/Acetylsalicylic acid Zentiva


Norway


1.3.2021




EU/1/96/024


Crixivan


Iceland


14.4.2021




EU/1/96/024


Crixivan


Liechtenstein


30.4.2021




EU/1/96/024


Crixivan


Norway


16.6.2021




EU/1/17/1240


Cyltezo


Liechtenstein


28.2.2021




EU/1/01/187


DepoCyte


Liechtenstein


28.2.2021




EU/1/18/1300


Duzallo


Liechtenstein


28.2.2021




EU/1/13/908


Eperzan


Liechtenstein


28.2.2021




EU/1/09/510


Fertavid


Liechtenstein


28.2.2021




EU/1/18/1288


Halimatoz


Iceland


12.1.2021




EU/1/18/1288


Halimatoz


Liechtenstein


28.2.2021




EU/1/18/1288


Halimatoz


Norway


9.2.2021




EU/1/00/144


Helixate NexGen


Liechtenstein


28.2.2021




EU/1/13/876


Imatinib Medac


Liechtenstein


28.2.2021




EU/1/17/1243


Imatinib Teva B.V.


Liechtenstein


28.2.2021




EU/1/08/505


Intanza


Liechtenstein


28.2.2021




EU/1/01/191


Ketek


Liechtenstein


28.2.2021




EU/1/13/895


Kolbam


Liechtenstein


28.2.2021




EU/1/20/1516


Lextemy


Liechtenstein


30.6.2021




EU/1/16/1162


Lusduna


Liechtenstein


28.2.2021




EU/1/05/325


Macugen


Liechtenstein


28.2.2021




EU/1/04/297


Nodetrip (tidl.Xeristar)


Liechtenstein


30.6.2021




EU/1/04/297


Nodetrip (tidl.Xeristar)


Norway


16.6.2021




EU/1/01/186


Nonafact


Liechtenstein


28.2.2021




EU/1/15/1044


Numient


Liechtenstein


28.2.2021




EU/1/14/924


Olysio


Liechtenstein


28.2.2021




EU/1/04/287


Osseor


Liechtenstein


28.2.2021




EU/1/00/131


PegIntron


Iceland


17.5.2021




EU/1/00/131


PegIntron


Liechtenstein


30.4.2021




EU/1/00/131


PegIntron


Norway


6.5.2021




EU/1/15/1084


Portrazza


Iceland


2.3.2021




EU/1/15/1084


Portrazza


Liechtenstein


28.2.2021




EU/1/08/453


Prepandrix


Iceland


14.1.2021




EU/1/08/453


Prepandrix


Liechtenstein


28.2.2021




EU/1/08/453


Prepandrix


Norway


9.2.2021




EU/1/04/288


Protelos


Liechtenstein


28.2.2021




EU/1/20/1463


Qutavina


Liechtenstein


15.1.2021




EU/1/10/634


Ribavirin Mylan


Liechtenstein


28.2.2021




EU/1/07/388


Sebivo


Liechtenstein


15.1.2021




EU/1/06/358


Silgard


Liechtenstein


28.2.2021




EU/1/16/1163


Solymbic


Liechtenstein


28.2.2021




EU/1/15/1017


Taxespira


Liechtenstein


28.2.2021




EU/1/09/610


Telmisartan Teva


Iceland


9.6.2021




EU/1/09/610


Telmisartan Teva


Liechtenstein


30.6.2021




EU/1/09/610


Telmisartan Teva


Norway


16.6.2021




EU/1/09/552


Topotecan Teva


Liechtenstein


28.2.2021




EU/1/16/1126


Truberzi


Iceland


12.1.2021




EU/1/16/1126


Truberzi


Liechtenstein


15.1.2021




EU/1/16/1126


Truberzi


Norway


3.2.2021




EU/1/18/1303


Udenyca


Iceland


18.2.2021




EU/1/18/1303


Udenyca


Liechtenstein


28.2.2021




EU/1/18/1303


Udenyca


Norway


15.2.2021




EU/1/17/1180


Varuby


Liechtenstein


28.2.2021




EU/1/12/752


Vepacel


Liechtenstein


15.1.2021




EU/1/11/705


Vibativ


Liechtenstein


28.2.2021




EU/1/11/704


Victrelis


Liechtenstein


28.2.2021




EU/1/00/132


ViraferonPeg


Iceland


19.1.2021




EU/1/00/132


ViraferonPeg


Liechtenstein


28.2.2021




EU/1/00/132


ViraferonPeg


Norway


29.1.2021




EU/1/11/671


Xiapex


Liechtenstein


28.2.2021




EU/1/16/1121


Zalmoxis


Liechtenstein


28.2.2021









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 2021:








EU-Number


Product


Country


Date of suspension