Medicinal Products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2022 2023/C 87/08 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee
Date: 2023-03-09
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_2023087EN.01001401.xml










9.3.2023   


EN


Official Journal of the European Union


C 87/14






Medicinal Products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2022
(2023/C 87/08)
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 2022, at their meeting on 28 October 2022:







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List of withdrawn marketing authorisations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 2022:








EU-Number


Product


Country


Date of authorisation




EU/1/21/1540


Dasatinib Accord


Norway


7.4.2022




EU/1/21/1540


Dasatinib Accord


Iceland


8.4.2022




EU/1/21/1540


Dasatinib Accord


Liechtenstein


31.3.2022




EU/1/21/1541


Dasatinib Accordpharma


Norway


7.4.2022




EU/1/21/1541


Dasatinib Accordpharma


Iceland


8.4.2022




EU/1/21/1541


Dasatinib Accordpharma


Liechtenstein


31.3.2022




EU/1/21/1569


QINLOCK


Norway


11.1.2022




EU/1/21/1578


Ontilyv


Norway


25.2.2022




EU/1/21/1578


Ontilyv


Iceland


24.2.2022




EU/1/21/1578


Ontilyv


Liechtenstein


28.2.2022




EU/1/21/1579


Nexviadyme


Liechtenstein


30.6.2022




EU/1/21/1586


Voraxaze


Norway


24.1.2022




EU/1/21/1586


Voraxaze


Iceland


10.2.2022




EU/1/21/1586


Voraxaze


Liechtenstein


31.1.2022




EU/1/21/1596


Tepmetko


Norway


22.2.2022




EU/1/21/1596


Tepmetko


Iceland


22.2.2022




EU/1/21/1596


Tepmetko


Liechtenstein


28.2.2022




EU/1/21/1598


Sitagliptin SUN


Norway


3.1.2022




EU/1/21/1599


Vyepti


Norway


7.2.2022




EU/1/21/1599


Vyepti


Iceland


28.1.2022




EU/1/21/1599


Vyepti


Liechtenstein


31.1.2022




EU/1/21/1600


Tecovirimat SIGA


Norway


17.1.2022




EU/1/21/1600


Tecovirimat SIGA


Iceland


14.1.2022




EU/1/21/1600


Tecovirimat SIGA


Liechtenstein


31.1.2022




EU/1/21/1602


Uplizna


Norway


16.5.2022




EU/1/21/1602


Uplizna


Iceland


13.5.2022




EU/1/21/1602


Uplizna


Liechtenstein


30.4.2022




EU/1/21/1603


Lumykras


Norway


11.1.2022




EU/1/21/1603


Lumykras


Iceland


25.1.2022




EU/1/21/1603


Lumykras


Liechtenstein


31.1.2022




EU/1/21/1604


Riltrava Aerosphere


Norway


11.1.2022




EU/1/21/1604


Riltrava Aerosphere


Iceland


19.1.2022




EU/1/21/1604


Riltrava Aerosphere


Liechtenstein


31.1.2022




EU/1/21/1605


Tavneos


Norway


19.1.2022




EU/1/21/1605


Tavneos


Iceland


14.2.2022




EU/1/21/1605


Tavneos


Liechtenstein


31.1.2022




EU/1/21/1606


Yselty


Norway


22.6.2022




EU/1/21/1606


Yselty


Iceland


21.6.2022




EU/1/21/1606


Yselty


Liechtenstein


30.6.2022




EU/1/21/1607


Lonapegsomatropin Ascendis Pharma


Norway


21.1.2022




EU/1/21/1607


Lonapegsomatropin Ascendis Pharma


Iceland


1.2.2022




EU/1/21/1607


Lonapegsomatropin Ascendis Pharma


Liechtenstein


31.1.2022




EU/1/21/1608


Wegovy


Norway


12.1.2022




EU/1/21/1608


Wegovy


Iceland


19.1.2022




EU/1/21/1608


Wegovy


Liechtenstein


31.1.2022




EU/1/21/1611


Vildagliptin/Metformin hydrochloride Accord


Norway


06.4.2022




EU/1/21/1611


Vildagliptin/Metformin hydrochloride Accord


Iceland


19.4.2022




EU/1/21/1611


Vildagliptin/Metformin hydrochloride Accord


Liechtenstein


31.3.2022




EU/1/21/1612


Apexxnar


Norway


22.2.2022




EU/1/21/1612


Apexxnar


Iceland


22.2.2022




EU/1/21/1612


Apexxnar


Liechtenstein


28.2.2022




EU/1/21/1615


Padcev


Norway


21.4.2022




EU/1/21/1615


Padcev


Iceland


4.5.2022




EU/1/21/1615


Padcev


Liechtenstein


30.4.2022




EU/1/21/1616


Kerendia


Norway


22.2.2022




EU/1/21/1616


Kerendia


Iceland


24.2.2022




EU/1/21/1616


Kerendia


Liechtenstein


28.2.2022




EU/1/21/1617


Ngenla


Norway


22.2.2022




EU/1/21/1617


Ngenla


Iceland


22.2.2022




EU/1/21/1617


Ngenla


Liechtenstein


28.2.2022




EU/1/21/1619


Sitagliptin/Metformin hydrochloride Mylan


Norway


24.3.2022




EU/1/21/1619


Sitagliptin/Metformin hydrochloride Mylan


Iceland


15.3.2022




EU/1/21/1619


Sitagliptin/Metformin hydrochloride Mylan


Liechtenstein


28.2.2022




EU/1/21/1620


Sapropterin Dipharma


Norway


22.2.2022




EU/1/21/1620


Sapropterin Dipharma


Iceland


22.2.2022




EU/1/21/1620


Sapropterin Dipharma


Liechtenstein


28.2.2022




EU/1/21/1621


OKEDI


Norway


21.2.2022




EU/1/21/1621


OKEDI


Iceland


16.2.2022




EU/1/21/1621


OKEDI


Liechtenstein


28.2.2022




EU/1/21/1622


Oxbryta


Norway


21.2.2022




EU/1/21/1622


Oxbryta


Iceland


22.2.2022




EU/1/21/1622


Oxbryta


Liechtenstein


28.2.2022




EU/1/21/1623


Saphnelo


Norway


21.2.2022




EU/1/21/1623


Saphnelo


Iceland


21.2.2022




EU/1/21/1623


Saphnelo


Liechtenstein


28.2.2022




EU/1/21/1624


Covid-19 Vaccine (inactivated, adjuvanted) Valneva


Norway


27.6.2022




EU/1/21/1624


COVID-19 Vaccine (inactivated, adjuvanted) Valneva


Iceland


28.6.2022




EU/1/21/1624


COVID-19 Vaccine (inactivated, adjuvanted) Valneva


Liechtenstein


30.6.2022




EU/1/22/1625


Paxlovid


Norway


28.1.2022




EU/1/22/1625


Paxlovid


Iceland


1.2.2022




EU/1/22/1625


Paxlovid


Liechtenstein


31.1.2022




EU/1/22/1628


Sondelbay


Norway


7.4.2022




EU/1/22/1628


Sondelbay


Iceland


20.4.2022




EU/1/22/1628


Sondelbay


Liechtenstein


31.3.2022




EU/1/22/1629


Zolsketil pegylated liposomal


Iceland


10.6.2022




EU/1/22/1629


Zolsketil pegylated liposomal


Liechtenstein


31.5.2022




EU/1/22/1630


Kimmtrak


Norway


12.4.2022




EU/1/22/1630


Kimmtrak


Iceland


27.4.2022




EU/1/22/1630


Kimmtrak


Liechtenstein


30.4.2022




EU/1/22/1631


Breyanzi


Norway


20.4.2022




EU/1/22/1631


Breyanzi


Iceland


4.5.2022




EU/1/22/1631


Breyanzi


Liechtenstein


30.4.2022




EU/1/22/1632


Stimufend


Norway


7.4.2022




EU/1/22/1632


Stimufend


Iceland


20.4.2022




EU/1/22/1632


Stimufend


Liechtenstein


31.3.2022




EU/1/22/1633


Sitagliptin Accord


Norway


16.5.2022




EU/1/22/1633


Sitagliptin Accord


Iceland


17.5.2022




EU/1/22/1633


Sitagliptin Accord


Liechtenstein


30.4.2022




EU/1/22/1634


Dimethyl Fumarate Mylan


Norway


23.5.2022




EU/1/22/1634


Dimethyl Fumarate Mylan


Iceland


18.5.2022




EU/1/22/1634


Dimethyl fumarate Mylan


Liechtenstein


31.5.2022




EU/1/22/1635


Dimethyl fumarate Polpharma


Norway


20.5.2022




EU/1/22/1635


Dimethyl fumarate Polpharma


Iceland


19.5.2022




EU/1/22/1635


Dimethyl fumarate Polpharma


Liechtenstein


31.5.2022




EU/1/22/1637


Dimethyl fumarate Neuraxpharm


Norway


20.5.2022




EU/1/22/1637


Dimethyl fumarate Neuraxpharm


Iceland


19.5.2022




EU/1/22/1637


Dimethyl fumarate Neuraxpharm


Liechtenstein


31.5.2022




EU/1/22/1638


Quviviq


Norway


20.5.2022




EU/1/22/1638


Quviviq


Iceland


28.6.2022




EU/1/22/1638


Quviviq


Liechtenstein


30.4.2022




EU/1/22/1639


Truvelog Mix 30


Norway


29.4.2022




EU/1/22/1639


Truvelog Mix 30


Iceland


12.5.2022




EU/1/22/1639


Truvelog Mix 30


Liechtenstein


30.4.2022




EU/1/22/1640


Amversio


Norway


20.5.2022




EU/1/22/1640


Amversio


Iceland


19.5.2022




EU/1/22/1640


Amversio


Liechtenstein


31.5.2022




EU/1/22/1641


PreHevbri


Norway


16.5.2022




EU/1/22/1641


PreHevbri


Iceland


18.5.2022




EU/1/22/1641


PreHevbri


Liechtenstein


30.4.2022




EU/1/22/1642


Orgovyx


Norway


16.5.2022




EU/1/22/1642


Orgovyx


Iceland


12.5.2022




EU/1/22/1642


Orgovyx


Liechtenstein


30.4.2022




EU/1/22/1643


Kapruvia


Norway


25.4.2022




EU/1/22/1643


Kapruvia


Iceland


11.5.2022




EU/1/22/1643


Kapruvia


Liechtenstein


30.4.2022




EU/1/22/1644


Inpremzia


Norway


20.5.2022




EU/1/22/1644


Inpremzia


Iceland


18.5.2022




EU/1/22/1644


Inpremzia


Liechtenstein


30.4.2022




EU/1/22/1645


Vydura


Norway


29.4.2022




EU/1/22/1645


Vydura


Iceland


11.5.2022




EU/1/22/1645


Vydura


Liechtenstein


30.4.2022




EU/1/22/1646


Amifampridine SERB


Norway


31.5.2022




EU/1/22/1646


Amifampridine SERB


Liechtenstein


31.5.2022




EU/1/22/1647


Camcevi


Norway


31.5.2022




EU/1/22/1647


Camcevi


Iceland


9.6.2022




EU/1/22/1647


Camcevi


Liechtenstein


31.5.2022




EU/1/22/1648


Carvykti


Norway


31.5.2022




EU/1/22/1648


Carvykti


Iceland


9.6.2022




EU/1/22/1648


Carvykti


Liechtenstein


31.5.2022




EU/1/22/1649


Lunsumio


Norway


16.6.2022




EU/1/22/1649


Lunsumio


Iceland


15.6.2022




EU/1/22/1649


Lunsumio


Liechtenstein


30.6.2022




EU/1/22/1650


Tabrecta


Liechtenstein


30.6.2022




EU/1/22/1651


Evusheld


Norway


28.3.2022




EU/1/22/1651


Evusheld


Iceland


30.3.2022




EU/1/22/1651


Evusheld


Liechtenstein


31.3.2022




EU/1/22/1652


Filsuvez


Liechtenstein


30.6.2022




EU/1/22/1655


Pirfenidone AET


Liechtenstein


30.6.2022




EU/1/22/1659


Xenpozyme


Liechtenstein


30.6.2022




EU/2/21/279


Zenalpha


Norway


7.1.2022




EU/2/21/280


Imoxat


Norway


7.1.2022




EU/2/21/281


CircoMax


Norway


17.1.2022




EU/2/21/281


CircoMax


Liechtenstein


31.1.2022




EU/2/22/282


RenuTend


Norway


29.4.2022




EU/2/22/282


RenuTend


Iceland


24.5.2022




EU/2/22/282


RenuTend


Liechtenstein


30.4.2022




EU/2/22/283


Chanaxin


Norway


9.6.2022




EU/2/22/283


Chanaxin


Iceland


14.6.2022




EU/2/22/283


Chanaxin


Liechtenstein


30.4.2022









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 2022:








EU-Number


Product


Country


Date of authorisation




EU/1/11/699


Fampyra


Norway


9.5.2022




EU/1/11/699


Fampyra


Liechtenstein


30.4.2022




EU/1/11/749


Caprelsa


Norway


24.1.2022




EU/1/11/749


Caprelsa


Iceland


20.1.2022




EU/1/11/749


Caprelsa


Liechtenstein


31.1.2022




EU/1/12/782


Kalydeco


Norway


20.5.2022




EU/1/12/782


Kalydeco


Liechtenstein


30.4.2022




EU/1/12/784


Cuprymina


Iceland


28.6.2022




EU/1/12/784


Cuprymina


Liechtenstein


30.6.2022




EU/1/13/818


Bosulif


Norway


16.5.2022




EU/1/13/818


Bosulif


Iceland


20.4.2022




EU/1/13/818


Bosulif


Liechtenstein


31.3.2022




EU/1/13/875


Deltyba


Norway


30.3.2022




EU/1/13/875


Deltyba


Iceland


6.4.2022




EU/1/13/875


Deltyba


Liechtenstein


31.3.2022




EU/1/13/901


Sirturo


Norway


26.1.2022




EU/1/13/901


Sirturo


Iceland


14.1.2022




EU/1/13/901


Sirturo


Liechtenstein


31.1.2022




EU/1/13/902


Translarna


Iceland


28.6.2022




EU/1/13/902


Translarna


Liechtenstein


30.6.2022




EU/1/14/987


Holoclar


Norway


8.4.2022




EU/1/14/987


Holoclar


Iceland


11.1.2022




EU/1/14/987


Holoclar


Liechtenstein


31.1.2022




EU/1/15/1078


Natpar


Norway


19.4.2022




EU/1/15/1078


Natpar


Iceland


6.4.2022




EU/1/15/1078


Natpar


Liechtenstein


31.3.2022




EU/1/15/999


Zykadia


Norway


22.2.2022




EU/1/15/999


Zykadia


Iceland


22.2.2022




EU/1/15/999


Zykadia


Liechtenstein


28.2.2022




EU/1/16/1086


Tagrisso


Norway


6.4.2022




EU/1/16/1086


Tagrisso


Iceland


20.4.2022




EU/1/16/1086


Tagrisso


Liechtenstein


31.3.2022




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Norway


8.4.2022




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Iceland


16.3.2022




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Liechtenstein


31.3.2022




EU/1/16/1101


Darzalex


Norway


21.1.2022




EU/1/16/1101


Darzalex


Iceland


14.1.2022




EU/1/16/1101


Darzalex


Liechtenstein


31.1.2022




EU/1/16/1139


Ocaliva


Norway


24.1.2022




EU/1/16/1139


Ocaliva


Iceland


21.1.2022




EU/1/16/1139


Ocaliva


Liechtenstein


31.1.2022




EU/1/16/1152


Roteas


Norway


13.1.2022




EU/1/16/1152


Roteas


Iceland


11.1.2022




EU/1/16/1152


Roteas


Liechtenstein


31.1.2022




EU/1/16/1154


Vemlidy


Norway


4.1.2022




EU/1/16/1154


Vemlidy


Iceland


5.1.2022




EU/1/16/1154


Vemlidy


Liechtenstein


31.1.2022




EU/1/16/1155


Kyntheum


Norway


29.4.2022




EU/1/16/1155


Kyntheum


Iceland


11.5.2022




EU/1/16/1155


Kyntheum


Liechtenstein


30.4.2022




EU/1/16/1171


Ledaga


Norway


17.1.2022




EU/1/16/1171


Ledaga


Iceland


14.1.2022




EU/1/16/1171


Ledaga


Liechtenstein


31.1.2022




EU/1/17/1172


Jylamvo


Norway


24.1.2022




EU/1/17/1172


Jylamvo


Iceland


5.1.2022




EU/1/17/1172


Jylamvo


Liechtenstein


31.1.2022




EU/1/17/1174


Rolufta Ellipta


Norway


14.1.2022




EU/1/17/1174


Rolufta Ellipta


Iceland


14.1.2022




EU/1/17/1174


Rolufta Ellipta


Liechtenstein


31.1.2022




EU/1/17/1175


Daptomycin Hospira


Norway


13.1.2022




EU/1/17/1175


Daptomycin Hospira


Iceland


25.1.2022




EU/1/17/1176


Yargesa


Norway


24.1.2022




EU/1/17/1176


Yargesa


Iceland


20.1.2022




EU/1/17/1176


Yargesa


Liechtenstein


31.1.2022




EU/1/17/1178


Xeljanz


Norway


14.3.2022




EU/1/17/1178


Xeljanz


Iceland


15.3.2022




EU/1/17/1178


Xeljanz


Liechtenstein


31.3.2022




EU/1/17/1179


Veltassa


Norway


6.4.2022




EU/1/17/1179


Veltassa


Iceland


19.4.2022




EU/1/17/1179


Veltassa


Liechtenstein


31.3.2022




EU/1/17/1181


Spherox


Norway


8.6.2022




EU/1/17/1181


Spherox


Iceland


19.5.2022




EU/1/17/1181


Spherox


Liechtenstein


30.4.2022




EU/1/17/1182


Emtricitabine/Tenofovir disoproxil Krka d.d


Norway


24.1.2022




EU/1/17/1182


Emtricitabine/Tenofovir disoproxil Krka d.d.


Iceland


21.1.2022




EU/1/17/1182


Emtricitabine /Tenofovir disoproxil Krka d.d.


Liechtenstein


31.1.2022




EU/1/17/1184


Riximyo


Norway


22.2.2022




EU/1/17/1184


Riximyo


Iceland


23.2.2022




EU/1/17/1184


Riximyo


Liechtenstein


28.2.2022




EU/1/17/1185


Rixathon


Norway


14.3.2022




EU/1/17/1185


Rixathon


Iceland


15.3.2022




EU/1/17/1185


Rixathon


Liechtenstein


28.2.2022




EU/1/17/1186


Axumin


Norway


16.2.2022




EU/1/17/1186


Axumin


Iceland


16.2.2022




EU/1/17/1186


Axumin


Liechtenstein


28.2.2022




EU/1/17/1187


Trumenba


Norway


9.5.2022




EU/1/17/1187


Trumenba


Iceland


11.5.2022




EU/1/17/1187


Trumenba


Liechtenstein


30.4.2022




EU/1/17/1188


Spinraza


Norway


7.2.2022




EU/1/17/1188


Spinraza


Iceland


11.2.2022




EU/1/17/1188


Spinraza


Liechtenstein


31.1.2022




EU/1/17/1189


Elmiron


Norway


26.1.2022




EU/1/17/1189


Elmiron


Iceland


21.1.2022




EU/1/17/1189


Elmiron


Liechtenstein


31.1.2022




EU/1/17/1190


Ivabradine Accord


Norway


18.2.2022




EU/1/17/1190


Ivabradine Accord


Iceland


22.2.2022




EU/1/17/1190


Ivabradine Accord


Liechtenstein


28.2.2022




EU/1/17/1191


Qarziba


Norway


27.1.2022




EU/1/17/1191


Qarziba


Iceland


19.1.2022




EU/1/17/1191


Qarziba


Liechtenstein


31.1.2022




EU/1/17/1192


Brineura


Liechtenstein


31.3.2022




EU/1/17/1192


Brineura


Norway


15.5.2022




EU/1/17/1193


Refixia


Norway


5.4.2022




EU/1/17/1193


Refixia


Iceland


15.3.2022




EU/1/17/1193


Refixia


Liechtenstein


28.2.2022




EU/1/17/1194


Febuxostat Mylan


Norway


21.2.2022




EU/1/17/1194


Febuxostat Mylan


Iceland


23.2.2022




EU/1/17/1194


Febuxostat Mylan


Liechtenstein


28.2.2022




EU/1/17/1195


Erelzi


Iceland


27.4.2022




EU/1/17/1195


Erelzi


Liechtenstein


30.4.2022




EU/1/17/1196


Kevzara


Norway


9.5.2022




EU/1/17/1196


Kevzara


Iceland


11.5.2022




EU/1/17/1196


Kevzara


Liechtenstein


30.4.2022




EU/1/17/1197


Oxervate


Norway


12.4.2022




EU/1/17/1197


Oxervate


Iceland


20.4.2022




EU/1/17/1197


Oxervate


Liechtenstein


31.3.2022




EU/1/17/1200


Besponsa


Norway


22.2.2022




EU/1/17/1200


Besponsa


Iceland


21.2.2022




EU/1/17/1200


Besponsa


Liechtenstein


28.2.2022




EU/1/17/1201


Skilarence


Norway


24.2.2022




EU/1/17/1201


Skilarence


Iceland


24.2.2022




EU/1/17/1201


Skilarence


Liechtenstein


28.2.2022




EU/1/17/1202


Ucedane


Norway


29.4.2022




EU/1/17/1202


Ucedane


Iceland


25.4.2022




EU/1/17/1202


Ucedane


Liechtenstein


31.3.2022




EU/1/17/1203


Insulin lispro Sanofi


Norway


29.4.2022




EU/1/17/1203


Insulin lispro Sanofi


Iceland


3.5.2022




EU/1/17/1203


Insulin lispro Sanofi


Liechtenstein


31.3.2022




EU/1/17/1205


Blitzima


Norway


29.4.2022




EU/1/17/1205


Blitzima


Iceland


6.5.2022




EU/1/17/1205


Blitzima


Liechtenstein


30.4.2022




EU/1/17/1208


Trimbow


Norway


31.3.2022




EU/1/17/1208


Trimbow


Iceland


19.4.2022




EU/1/17/1208


Trimbow


Liechtenstein


31.3.2022




EU/1/17/1209


Reagila


Norway


20.4.2022




EU/1/17/1209


Reagila


Iceland


20.4.2022




EU/1/17/1209


Reagila


Liechtenstein


30.4.2022




EU/1/17/1210


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


Norway


31.5.2022




EU/1/7/1210


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


Iceland


9.6.2022




EU/1/17/1210


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


Liechtenstein


31.5.2022




EU/1/17/1212


Mavenclad


Norway


29.4.2022




EU/1/17/1212


Mavenclad


Iceland


11.5.2022




EU/1/17/1212


Mavenclad


Liechtenstein


30.4.2022




EU/1/17/1213


Maviret


Iceland


20.4.2022




EU/1/17/1213


Maviret


Liechtenstein


31.3.2022




EU/1/17/1216


Imraldi


Norway


9.5.2022




EU/1/17/1216


Imraldi


Iceland


17.5.2022




EU/1/17/1216


Imraldi


Liechtenstein


30.4.2022




EU/1/17/1218


Rydapt


Iceland


10.6.2022




EU/1/17/1218


Rydapt


Liechtenstein


31.5.2022




EU/1/17/1220


Tecentriq


Norway


29.4.2022




EU/1/17/1220


Tecentriq


Iceland


6.5.2022




EU/1/17/1220


Tecentriq


Liechtenstein


30.4.2022




EU/1/17/1221


Kisqali


Norway


20.4.2022




EU/1/17/1221


Kisqali


Iceland


27.4.2022




EU/1/17/1221


Kisqali


Liechtenstein


30.4.2022




EU/1/17/1222


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


Iceland


9.6.2022




EU/1/17/1222


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


Liechtenstein


31.5.2022




EU/1/17/1223


Vosevi


Norway


20.5.2022




EU/1/17/1223


Vosevi


Liechtenstein


31.5.2022




EU/1/17/1224


Xermelo


Liechtenstein


30.6.2022




EU/1/17/1225


Symtuza


Norway


31.5.2022




EU/1/17/1225


Symtuza


Iceland


9.6.2022




EU/1/17/1225


Symtuza


Liechtenstein


31.5.2022




EU/1/17/1227


Entecavir Mylan


Liechtenstein


30.6.2022




EU/1/17/1250


Rubraca


Norway


24.3.2022




EU/1/17/1250


Rubraca


Iceland


16.3.2022




EU/1/17/1250


Rubraca


Liechtenstein


31.3.2022




EU/1/17/1262


Crysvita


Norway


11.2.2022




EU/1/17/1262


Crysvita


Iceland


25.1.2022




EU/1/17/1262


Crysvita


Liechtenstein


31.1.2022




EU/1/18/1345


Ondexxya


Norway


30.6.2022




EU/1/18/1345


Ondexxya


Iceland


17.5.2022




EU/1/18/1345


Ondexxya


Liechtenstein


30.4.2022




EU/1/19/1355


Lorviqua


Iceland


25.4.2022




EU/1/19/1355


Lorviqua


Liechtenstein


30.4.2022




EU/1/19/1360


Waylivra


Norway


24.2.2022




EU/1/19/1360


Waylivra


Iceland


21.2.2022




EU/1/19/1360


Waylivra


Liechtenstein


28.2.2022




EU/1/20/1437


Dovprela


Liechtenstein


30.6.2022




EU/1/20/1443


Zolgensma


Norway


31.5.2022




EU/1/20/1443


Zolgensma


Iceland


9.6.2022




EU/1/20/1443


Zolgensma


Liechtenstein


31.5.2022




EU/1/20/1446


Hepcludex


Liechtenstein


30.6.2022




EU/1/20/1459


Veklury


Norway


29.4.2022




EU/1/20/1459


Veklury


Iceland


4.5.2022




EU/1/20/1459


Veklury


Liechtenstein


30.4.2022




EU/1/20/1460


Rozlytrek


Liechtenstein


31.5.2022




EU/1/20/1474


BLENREP


Liechtenstein


30.6.2022




EU/1/20/1525


COVID- 19 Vaccine Janssen (JCOVDEN)


Norway


24.1.2022




EU/1/20/1525


COVID-19 Vaccine Janssen (JCOVDEN)


Iceland


14.2.2022




EU/1/20/1525


COVID-19 Vaccine Janssen (JCOVDEN)


Liechtenstein


31.1.2022




EU/1/20/1527


Retsevmo


Norway


26.1.2022




EU/1/20/1527


Retsevmo


Iceland


4.1.2022




EU/1/21/1535


Pemazyre


Norway


22.2.2022




EU/1/21/1535


Pemazyre


Iceland


23.2.2022




EU/1/21/1535


Pemazyre


Liechtenstein


28.2.2022




EU/1/21/1537


NEXPOVIO


Norway


2.6.2022




EU/1/21/1537


NEXPOVIO


Iceland


19.5.2022




EU/1/21/1537


NEXPOVIO


Liechtenstein


31.5.2022




EU/1/21/1538


Jemperli


Norway


22.2.2022




EU/1/21/1538


Jemperli


Iceland


22.2.2022




EU/1/21/1538


Jemperli


Liechtenstein


28.2.2022




EU/1/21/1539


Abecma


Liechtenstein


30.6.2022




EU/1/21/1552


Koselugo


Norway


12.5.2022




EU/1/21/1552


Koselugo


Liechtenstein


30.4.2022




EU/2/16/203


VarroMed


Norway


24.1.2022




EU/2/16/203


VarroMed


Iceland


21.1.2022




EU/2/16/203


VarroMed


Liechtenstein


31.1.2022




EU/2/17/205


Cytopoint


Norway


29.6.2022




EU/2/17/205


Cytopoint


Liechtenstein


30.4.2022




EU/2/17/206


Credelio


Norway


29.6.2022




EU/2/17/206


Credelio


Liechtenstein


30.4.2022




EU/2/17/207


Zulvac BTV


Norway


29.6.2022




EU/2/17/207


Zulvac BTV


Liechtenstein


30.4.2022




EU/2/17/209


RESPIPORC FLUpan H1N1


Norway


29.6.2022




EU/2/17/209


RESPIPORC FLUpan H1N1


Liechtenstein


30.4.2022




EU/2/17/210


Zeleris


Norway


30.6.2022




EU/2/17/210


Zeleris


Iceland


18.5.2022




EU/2/17/210


Zeleris


Liechtenstein


31.5.2022









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 2022:








EU-Number


Product


Country


Date of authorisation




EU/1/05/320/005


Noxafil


Liechtenstein


31.1.2022




EU/1/05/320/005


Noxafil


Norway


24.1.2022




EU/1/05/320/005


Noxafil


Iceland


20.1.2022




EU/1/05/324


Naglazyme


Liechtenstein


30.4.2022




EU/1/13/837


Tecfidera


Liechtenstein


31.5.2022




EU/1/14/930


Jardiance


Liechtenstein


31.3.2022




EU/1/14/936/008


Nuwiq


Liechtenstein


31.1.2022




EU/1/14/936/008


Nuwiq


Norway


24.1.2022




EU/1/14/936/008


Nuwiq


Iceland


20.1.2022




EU/1/15/1043/009-010


Nucala


Liechtenstein


30.4.2022




EU/1/15/1043/009-010


Nucala


Norway


24.5.2022




EU/1/15/1043/009-010


Nucala


Iceland


23.6.2022




EU/1/16/1116/003-004


Epclusa


Liechtenstein


31.1.2022




EU/1/16/1116/003-004


Epclusa


Norway


7.1.2022




EU/1/16/1116/003-004


Epclusa


Iceland


18.1.2022




EU/1/17/1217/004


Nitisinone MDK


Iceland


5.1.2022




EU/1/17/1229/021-022


Dupixent


Liechtenstein


30.4.2022




EU/1/17/1229/021 -022


Dupixent


Iceland


27.4.2022




EU/1/17/1235/004-005


Zejula


Liechtenstein


31.5.2022




EU/1/17/1235/004-005


Zejula


Norway


30.5.2022




EU/1/17/1235/004-005


Zejula


Iceland


10.6.2022




EU/1/17/1247/015-016


Adynovi


Liechtenstein


31.1.2022




EU/1/17/1247/015-016


Adynovi


Norway


14.1.2022




EU/1/17/1247/015-016


Adynovi


Iceland


20.1.2022




EU/1/17/1251/010-011


Ozempic


Liechtenstein


31.1.2022




EU/1/17/1251/010-011


Ozempic


Norway


11.1.2022




EU/1/17/1251/010-011


Ozempic


Iceland


20.1.2022




EU/1/18/1274/006-008


Trydonis


Liechtenstein


31.1.2022




EU/1/18/1274/006-008


Trydonis


Norway


24.1.2022




EU/1/18/1274/006-008


Trydonis


Iceland


21.1.2022




EU/1/18/1323/003


Ilumetri


Liechtenstein


30.4.2022




EU/1/18/1323/003


Ilumetri


Norway


20.5.2022




EU/1/18/1323/003


Ilumetri


Iceland


28.6.2022




EU/1/19/1414/007-008


Mayzent


Liechtenstein


28.2.2022




EU/1/19/1414/007-008


Mayzent


Norway


16.2.2022




EU/1/19/1414/007-008


Mayzent


Iceland


24.2.2022




EU/1/20/1422/016-017


Lyumjev


Liechtenstein


30.4.2022




EU/1/20/1422/016-017


Lyumjev


Norway


18.5.2022




EU/1/20/1422/016-017


Lyumjev


Iceland


17.5.2022




EU/1/20/1468/002


Kaftrio


Liechtenstein


31.1.2022




EU/1/20/1468/002


Kaftrio


Norway


7.1.2022




EU/1/20/1468/002


Kaftrio


Iceland


19.1.2022




EU/1/20/1473/004-005


AYVAKYT


Liechtenstein


31.3.2022




EU/1/20/1473/004-005


AYVAKYT


Norway


31.3.2022




EU/1/20/1473/004-005


AYVAKYT


Iceland


19.4.2022




EU/1/20/1500/003-004


Xofluza


Liechtenstein


30.4.2022




EU/1/20/1500/003-004


Xofluza


Norway


29.4.2022




EU/1/20/1501/003-004


Sogroya


Liechtenstein


30.4.2022




EU/1/20/1501/003-004


Sogroya


Norway


29.4.2022




EU/1/20/1501/003-004


Sogroya


Iceland


12.5.2022




EU/1/20/1513/013-016


Yuflyma


Liechtenstein


28.2.2022




EU/1/20/1513/013-016


Yuflyma


Norway


16.2.2022




EU/1/20/1513/013-016


Yuflyma


Iceland


15.3.2022




EU/2/13/154/028-033


Apoquel


Norway


5.1.2022









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 2022:








EU-Number


Product


Country


Date of withdrawal




EU/1/01/174


Starlix


Norway


16.6.2022




EU/1/01/174


Starlix


Liechtenstein


30.4.2022




EU/1/03/249


Vivanza


Norway


1.3.2022




EU/1/03/249


Vivanza


Iceland


10.2.2022




EU/1/03/249


Vivanza


Liechtenstein


28.2.2022




EU/1/03/250


Ytracis


Norway


22.2.2022




EU/1/03/250


Ytracis


Iceland


5.1.2022




EU/1/07/384


Docetaxel Zentiva


Liechtenstein


31.5.2022




EU/1/07/384


Docetaxel Zentiva


Iceland


10.6.2022




EU/1/07/421


Glubrava


Norway


8.6.2022




EU/1/07/421


Glubrava


Liechtenstein


31.5.2022




EU/1/08/491


Rasilez HCT


Norway


22.2.2022




EU/1/08/491


Rasilez HCT


Iceland


11.1.2022




EU/1/09/519


PANTOLOC Control


Norway


10.1.2022




EU/1/09/519


PANTOLOC Control


Iceland


5.1.2022




EU/1/11/695


Leganto


Norway


18.1.2022




EU/1/11/695


Leganto


Iceland


5.1.2022




EU/1/11/695


Leganto


Liechtenstein


31.1.2022




EU/1/11/728


Pramipexole Accord


Norway


22.4.2022




EU/1/11/728


Pramipexole Accord


Iceland


4.5.2022




EU/1/11/728


Pramipexole Accord


Liechtenstein


30.4.2022




EU/1/13/825


Imatinib Actavis


Liechtenstein


31.5.2022




EU/1/15/1034


Pemetrexed Lilly


Norway


23.3.2022




EU/1/15/1034


Pemetrexed Lilly


Iceland


21.1.2022




EU/1/15/1034


Pemetrexed Lilly


Liechtenstein


31.3.2022




EU/1/15/1069


Episalvan


Iceland


16.6.2022




EU/1/15/1069


Episalvan


Liechtenstein


30.6.2022




EU/1/16/1131


Thorinane


Norway


4.3.2022




EU/1/16/1131


Thorinane


Liechtenstein


31.3.2022




EU/1/17/1183


Pemetrexed Pfizer


Norway


23.3.2022




EU/1/17/1183


Pemetrexed Pfizer


Iceland


27.1.2022




EU/1/17/1183


Pemetrexed Pfizer


Liechtenstein


31.1.2022




EU/1/19/1363


Zynquista


Norway


21.4.2022




EU/1/19/1363


Zynquista


Iceland


6.4.2022




EU/1/19/1363


Zynquista


Liechtenstein


31.3.2022




EU/1/19/1367


Zynteglo


Norway


21.4.2022




EU/1/19/1367


Zynteglo


Iceland


20.4.2022




EU/1/19/1367


Zynteglo


Liechtenstein


31.3.2022




EU/1/19/1387


Senstend


Liechtenstein


30.6.2022




EU/1/19/1421


Staquis


Norway


9.2.2022




EU/1/19/1421


Staquis


Iceland


10.2.2022




EU/1/19/1421


Staquis


Liechtenstein


31.1.2022




EU/2/14/180


Coliprotec F4


Norway


22.2.2022









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 2022:








EU-Number


Product


Country


Date of suspension