Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2022 2023/C 239/04 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee
Date: 2023-07-06
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_2023239EN.01005801.xml










6.7.2023   


EN


Official Journal of the European Union


C 239/58






Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2022
(2023/C 239/04)
Subcommittee I on the free movement of goods
To be noted by the EEA Joint Committee
With reference to EEA Joint Committee Decision No.74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July – 31 December 2022, at the meeting on 17 March 2023:







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List of withdrawn marketing authorisations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 2022:








EU-Number


Product


Country


Date of authorisation




EU/1/21/1579


Nexviadyme


Iceland


13.7.2022




EU/1/21/1579


Nexviadyme


Norway


4.7.2022




EU/1/21/1580


VidPrevtyn Beta


Iceland


7.12.2022




EU/1/21/1580


VidPrevtyn Beta


Liechtenstein


30.11.2022




EU/1/21/1580


VidPrevtyn Beta


Norway


11.11.2022




EU/1/21/1587


Rayvow


Iceland


31.8.2022




EU/1/21/1587


Rayvow


Liechtenstein


31.8.2022




EU/1/21/1587


Rayvow


Norway


6.9.2022




EU/1/22/1629


ZOLSKETIL pegylated liposomal


Norway


11.8.2022




EU/1/22/1646


Amifampridine SERB


Iceland


12.8.2022




EU/1/22/1650


Tabrecta


Iceland


12.7.2022




EU/1/22/1650


Tabrecta


Norway


5.7.2022




EU/1/22/1652


Filsuvez


Iceland


12.8.2022




EU/1/22/1652


Filsuvez


Norway


1.8.2022




EU/1/22/1653


Upstaza


Iceland


12.8.2022




EU/1/22/1653


Upstaza


Liechtenstein


31.7.2022




EU/1/22/1653


Upstaza


Norway


25.7.2022




EU/1/22/1655


Pirfenidone AET


Iceland


12.7.2022




EU/1/22/1655


Pirfenidone axunio


Liechtenstein


30.6.2022




EU/1/22/1655


Pirfenidone AET


Norway


5.7.2022




EU/1/22/1656


Ertapenem SUN


Iceland


11.8.2022




EU/1/22/1656


Ertapenem SUN


Liechtenstein


31.7.2022




EU/1/22/1656


Ertapenem SUN


Norway


10.8.2022




EU/1/22/1657


Kinpeygo


Iceland


19.7.2022




EU/1/22/1657


Kinpeygo


Liechtenstein


31.7.2022




EU/1/22/1657


Kinpeygo


Norway


21.7.2022




EU/1/22/1658


Ganirelix Gedeon Richter


Iceland


21.7.2022




EU/1/22/1658


Ganirelix Gedeon Richter


Liechtenstein


31.7.2022




EU/1/22/1658


Ganirelix Gedeon Richter


Norway


25.7.2022




EU/1/22/1659


Xenpozyme


Iceland


13.7.2022




EU/1/22/1659


Xenpozyme


Norway


4.7.2022




EU/1/22/1660


Zokinvy


Iceland


21.7.2022




EU/1/22/1660


Zokinvy


Liechtenstein


31.7.2022




EU/1/22/1660


Zokinvy


Norway


21.7.2022




EU/1/22/1661


Sitagliptin/Metformin hydrochloride Accord


Iceland


15.8.2022




EU/1/22/1661


Sitagliptin/Metformin Hydrochloride Accord


Liechtenstein


31.7.2022




EU/1/22/1661


Sitagliptin Metformin Hydrochloride Accord


Norway


1.8.2022




EU/1/22/1662


Pyrukynd


Iceland


1.12.2022




EU/1/22/1662


Pyrukynd


Liechtenstein


30.11.2022




EU/1/22/1662


Pyrukynd


Norway


30.11.2022




EU/1/22/1663


Sugammadex Fresenius Kabi


Iceland


19.7.2022




EU/1/22/1663


Sugammadex Fresenius Kabi


Liechtenstein


31.7.2022




EU/1/22/1663


Sugammadex Fresenius Kabi


Norway


25.7.2022




EU/1/22/1664


Cevenfacta


Iceland


12.8.2022




EU/1/22/1664


Cevenfacta


Liechtenstein


31.7.2022




EU/1/22/1664


Cevenfacta


Norway


22.8.2022




EU/1/22/1666


Celdoxome pegylated liposomal


Liechtenstein


30.9.2022




EU/1/22/1666


Celdoxome pegylated liposomal


Norway


10.10.2022




EU/1/22/1667


Celdoxome pegylated liposomal


Iceland


11.10.2022




EU/1/22/1667


Vegzelma


Iceland


23.8.2022




EU/1/22/1667


Vegzelma


Liechtenstein


31.8.2022




EU/1/22/1667


Vegzelma


Norway


30.8.2022




EU/1/22/1668


Roctavian


Iceland


31.8.2022




EU/1/22/1668


Roctavian


Liechtenstein


31.8.2022




EU/1/22/1668


Roctavian


Norway


30.8.2022




EU/1/22/1669


Pepaxti


Iceland


23.8.2022




EU/1/22/1669


Pepaxti


Liechtenstein


31.8.2022




EU/1/22/1669


Pepaxti


Norway


30.8.2022




EU/1/22/1670


Scemblix


Iceland


30.8.2022




EU/1/22/1670


Scemblix


Liechtenstein


31.8.2022




EU/1/22/1670


Scemblix


Norway


30.8.2022




EU/1/22/1671


Sunlenca


Iceland


23.8.2022




EU/1/22/1671


Sunlenca


Liechtenstein


31.8.2022




EU/1/22/1671


Sunlenca


Norway


30.8.2022




EU/1/22/1672


Livtencity


Iceland


1.12.2022




EU/1/22/1672


Livtencity


Liechtenstein


30.11.2022




EU/1/22/1672


Livtencity


Norway


9.11.2022




EU/1/22/1673


Ranivisio


Iceland


30.8.2022




EU/1/22/1673


Ranivisio


Liechtenstein


31.8.2022




EU/1/22/1673


Ranivisio


Norway


30.8.2022




EU/1/22/1674


Vyvgart


Iceland


17.8.2022




EU/1/22/1674


Vyvgart


Liechtenstein


31.8.2022




EU/1/22/1674


Vyvgart


Norway


15.8.2022




EU/1/22/1675


Tecvayli


Iceland


7.9.2022




EU/1/22/1675


Tecvayli


Liechtenstein


31.8.2022




EU/1/22/1675


Tecvayli


Norway


30.8.2022




EU/1/22/1676


Thalidomide Lipomed


Iceland


12.10.2022




EU/1/22/1676


Thalidomide Lipomed


Liechtenstein


30.9.2022




EU/1/22/1676


Thalidomide Lipomed


Norway


5.10.2022




EU/1/22/1677


Tezspire


Iceland


12.10.2022




EU/1/22/1677


Tezspire


Liechtenstein


30.9.2022




EU/1/22/1677


Tezspire


Norway


26.9.2022




EU/1/22/1678


Lupkynis


Iceland


12.10.2022




EU/1/22/1678


Lupkynis


Liechtenstein


30.9.2022




EU/1/22/1678


Lupkynis


Norway


20.9.2022




EU/1/22/1679


Opdualag


Iceland


11.10.2022




EU/1/22/1679


Opdualag


Liechtenstein


30.9.2022




EU/1/22/1679


Opdualag


Norway


20.9.2022




EU/1/22/1680


ilLuzyce


Iceland


10.10.2022




EU/1/22/1680


ilLuzyce


Liechtenstein


30.9.2022




EU/1/22/1680


ilLuzyce


Norway


20.9.2022




EU/1/22/1681


Amvuttra


Iceland


10.10.2022




EU/1/22/1681


Amvuttra


Liechtenstein


30.9.2022




EU/1/22/1681


Amvuttra


Norway


20.9.2022




EU/1/22/1683


Vabysmo


Iceland


11.10.2022




EU/1/22/1683


Vabysmo


Liechtenstein


30.9.2022




EU/1/22/1683


Vabysmo


Norway


26.9.2022




EU/1/22/1684


Nulibry


Liechtenstein


30.9.2022




EU/1/22/1684


Nulibry


Norway


26.9.2022




EU/1/22/1685


Mounjaro


Iceland


11.10.2022




EU/1/22/1685


Mounjaro


Liechtenstein


30.9.2022




EU/1/22/1685


Mounjaro


Norway


28.10.2022




EU/1/22/1687


Enjaymo


Iceland


8.12.2022




EU/1/22/1687


Enjaymo


Liechtenstein


30.11.2022




EU/1/22/1688


Spevigo


Liechtenstein


31.12.2022




EU/1/22/1688


Spevigo


Norway


21.12.2022




EU/1/22/1689


Beyfortus


Iceland


18.11.2022




EU/1/22/1689


Beyfortus


Liechtenstein


31.10.2022




EU/1/22/1689


Beyfortus


Norway


23.11.2022




EU/1/22/1690


Mycapssa


Iceland


14.12.2022




EU/1/22/1690


Mycapssa


Liechtenstein


31.12.2022




EU/1/22/1690


Mycapssa


Norway


2.12.2022




EU/1/22/1691


Ximluci


Iceland


1.12.2022




EU/1/22/1691


Ximluci


Liechtenstein


30.11.2022




EU/1/22/1691


Ximluci


Norway


30.11.2022




EU/1/22/1692


Locametz


Liechtenstein


31.12.2022




EU/1/22/1693


Teriflunomide Accord


Iceland


8.12.2022




EU/1/22/1693


Teriflunomide Accord


Liechtenstein


30.11.2022




EU/1/22/1693


Teriflunomide Accord


Norway


30.11.2022




EU/1/22/1694


Melatonin Neurim


Iceland


7.12.2022




EU/1/22/1694


Melatonin Neurim


Liechtenstein


30.11.2022




EU/1/22/1694


Melatonin Neurim


Norway


1.12.2022




EU/1/22/1695


Zynlonta


Liechtenstein


31.12.2022




EU/1/22/1696


Sorafenib Accord


Iceland


8.12.2022




EU/1/22/1696


Sorafenib Accord


Liechtenstein


30.11.2022




EU/1/22/1696


Sorafenib Accord


Norway


30.11.2022




EU/1/22/1697


Teriparatide Sun


Iceland


1.12.2022




EU/1/22/1697


Teriparatide Sun


Liechtenstein


30.11.2022




EU/1/22/1697


Teriparatide Sun


Norway


1.12.2022




EU/1/22/1698


Teriflunomide Mylan


Iceland


8.12.2022




EU/1/22/1698


Teriflunomide Mylan


Liechtenstein


30.11.2022




EU/1/22/1698


Teruflunamide Mylan


Norway


1.12.2022




EU/1/22/1699


Qdenga


Iceland


15.12.2022




EU/1/22/1699


Qdenga


Liechtenstein


31.12.2022




EU/1/22/1699


Qdenga


Norway


14.12.2022




EU/1/22/1700


Ebvallo


Liechtenstein


31.12.2022




EU/1/22/1700


Ebvallo


Norway


21.12.2022




EU/1/22/1701


Plerixafor Accord


Liechtenstein


31.12.2022




EU/1/22/1701


Plerixafor Accord


Norway


22.12.2022




EU/1/22/1702


Dimethyl Fumarate Teva


Liechtenstein


31.12.2022




EU/1/22/1703


Pluvicto


Liechtenstein


31.12.2022




EU/1/22/1703


Pluvicto


Norway


15.12.2022




EU/1/22/1704


Livmarli


Liechtenstein


31.12.2022




EU/1/22/1704


Livmarli


Norway


15.12.2022




EU/1/22/1705


Pemetrexed Baxter


Iceland


20.12.2022




EU/1/22/1705


Pemetrexed Baxter


Liechtenstein


31.12.2022




EU/1/22/1705


Pemetrexed Baxter


Norway


21.12.2022




EU/1/22/1706


Eladynos


Liechtenstein


31.12.2022




EU/1/22/1706


Eladynos


Norway


21.12.2022




EU/1/22/1687


Enjaymo


Norway


1.12.2022




EU/1/22/1687


Enjaymo


Liechtenstein


30.11.2022




EU/1/22/1656


Ertapenem Sun


Norway


10.8.2022




EU/1/22/1656


Ertapenem Sun


Liechtenstein


31.7.2022




EU/2/21/281


CircoMax


Iceland


12.8.2022




EU/2/22/284


Evanovo


Iceland


16.8.2022




EU/2/22/284


Evanovo


Liechtenstein


31.7.2022




EU/2/22/284


Evanovo


Norway


24.8.2022




EU/2/22/286


Coxatab


Iceland


31.8.2022




EU/2/22/286


Coxatab


Liechtenstein


31.8.2022




EU/2/22/286


Coxatab


Norway


1.9.2022




EU/2/22/287


Cortaderm


Iceland


17.8.2022




EU/2/22/287


Cortaderm


Liechtenstein


31.7.2022




EU/2/22/287


Cortaderm


Norway


24.8.2022




EU/2/22/288


Lotilaner Elanco


Iceland


13.10.2022




EU/2/22/288


Lotilaner Elanco


Liechtenstein


30.9.2022




EU/2/22/288


Lotilaner Elanco


Norway


11.10.2022









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 2022:








EU-Number


Product


Country


Date of authorisation




EU/1/11/699


Fampyra


Iceland


8.9.2022




EU/1/11/749


Caprelsa


Iceland


13.12.2022




EU/1/11/749


Caprelsa


Liechtenstein


30.11.2022




EU/1/11/749


Caprelsa


Norway


9.12.2022




EU/1/12/782


Kalydeco


Iceland


8.9.2022




EU/1/12/784


Cuprymina


Norway


5.7.2022




EU/1/12/794


Adcetris


Norway


27.9.2022




EU/1/12/794


Adcetris


Liechtenstein


31.5.2022 (1)





EU/1/12/803


NexoBrid


Iceland


23.8.2022




EU/1/12/803


NexoBrid


Liechtenstein


31.8.2022




EU/1/12/803


NexoBrid


Norway


30.8.2022




EU/1/13/901


Sirturo


Liechtenstein


31.12.2022




EU/1/13/902


Translarna


Norway


12.7.2022




EU/1/16/1094


Ninlaro


Iceland


6.10.2022




EU/1/16/1094


Ninlaro


Liechtenstein


30.9.2022




EU/1/16/1094


Ninlaro


Norway


24.10.2022




EU/1/16/1169


Alecensa


Iceland


11.8.2022




EU/1/16/1169


Alecensa


Liechtenstein


31.7.2022




EU/1/16/1169


Alecensa


Norway


17.8.2022




EU/1/17/1192


Brineura


Iceland


15.7.2022




EU/1/17/1192


Brineura


Norway


15.8.2022




EU/1/17/1195


Erelzi


Norway


16.8.2022




EU/1/17/1199


Cuprior


Iceland


30.8.2022




EU/1/17/1199


Cuprior


Liechtenstein


31.8.2022




EU/1/17/1199


Cuprior


Norway


30.8.2022




EU/1/17/1211


Entecavir Accord


Iceland


14.7.2022




EU/1/17/1211


Entecavir Accord


Liechtenstein


31.7.2022




EU/1/17/1211


Entecavir Accord


Norway


8.7.2022




EU/1/17/1213


Maviret


Norway


16.8.2022




EU/1/17/1215


Fotivda


Iceland


11.8.2022




EU/1/17/1215


Fotivda


Liechtenstein


31.7.2022




EU/1/17/1215


Fotivda


Norway


17.8.2022




EU/1/17/1217


Nitisinone MDK


Iceland


11.8.2022




EU/1/17/1217


Nitisinone MDK


Liechtenstein


31.7.2022




EU/1/17/1217


Nitisinone MDK


Norway


17.8.2022




EU/1/17/1218


Rydapt


Norway


15.8.2022




EU/1/17/1222


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


Norway


12.8.2022




EU/1/17/1223


Vosevi


Iceland


22.8.2022




EU/1/17/1224


Xermelo


Iceland


12.7.2022




EU/1/17/1224


Xermelo


Norway


12.07.2022




EU/1/17/1226


Lutathera


Iceland


14.7.2022




EU/1/17/1226


Lutathera


Liechtenstein


31.7.2022




EU/1/17/1226


Lutathera


Norway


21.7.2022




EU/1/17/1227


Entecavir Mylan


Iceland


12.7.2022




EU/1/17/1227


Entecavir Mylan


Norway


5.7.2022




EU/1/17/1228


Tookad


Iceland


13.10.2022




EU/1/17/1228


Tookad


Liechtenstein


30.9.2022




EU/1/17/1228


Tookad


Norway


27.10.2022




EU/1/17/1229


Dupixent


Iceland


8.9.2022




EU/1/17/1229


Dupixent


Liechtenstein


30.9.2022




EU/1/17/1229


Dupixent


Norway


6.9.2022




EU/1/17/1230


Lacosamide Accord


Iceland


30.8.2022




EU/1/17/1230


Lacosamide Accord


Liechtenstein


31.8.2022




EU/1/17/1230


Lacosamide Accord


Norway


24.8.2022




EU/1/17/1231


Ocrevus


Iceland


12.10.2022




EU/1/17/1231


Ocrevus


Liechtenstein


30.9.2022




EU/1/17/1231


Ocrevus


Norway


27.9.2022




EU/1/17/1232


Miglustat Gen.Orph


Iceland


12.10.2022




EU/1/17/1232


Miglustat Gen.Orph


Liechtenstein


30.9.2022




EU/1/17/1232


Miglustat Gen.Orph.


Norway


6.10.2022




EU/1/17/1233


Zubsolv


Iceland


12.8.2022




EU/1/17/1233


Zubsolv


Liechtenstein


31.7.2022




EU/1/17/1233


Zubsolv


Norway


25.8.2022




EU/1/17/1234


Tremfya


Iceland


21.7.2022




EU/1/17/1234


Tremfya


Liechtenstein


31.7.2022




EU/1/17/1234


Tremfya


Norway


21.7.2022




EU/1/17/1235


Zejula


Iceland


11.8.2022




EU/1/17/1235


Zejula


Liechtenstein


31.7.2022




EU/1/17/1235


Zejula


Norway


15.8.2022




EU/1/17/1236


Trelegy Ellipta


Iceland


19.7.2022




EU/1/17/1236


Trelegy Ellipta


Liechtenstein


31.7.2022




EU/1/17/1237


Elebrato Ellipta


Iceland


19.7.2022




EU/1/17/1237


Elebrato Ellipta


Liechtenstein


31.7.2022




EU/1/17/1237


Elebrato Ellipta


Norway


21.07.2022




EU/1/17/1238


Nyxoid


Iceland


7.10.2022




EU/1/17/1238


Nyxoid


Liechtenstein


30.9.2022




EU/1/17/1238


Nyxoid


Norway


20.9.2022




EU/1/17/1239


VeraSeal


Iceland


13.10.2022




EU/1/17/1239


VeraSeal


Liechtenstein


30.9.2022




EU/1/17/1239


VeraSeal


Norway


25.10.2022




EU/1/17/1241


Ontruzant


Iceland


17.8.2022




EU/1/17/1241


Ontruzant


Liechtenstein


31.7.2022




EU/1/17/1241


Ontruzant


Norway


18.8.2022




EU/1/17/1242


Ritonavir Mylan


Iceland


25.8.2022




EU/1/17/1242


Ritonavir Mylan


Liechtenstein


31.8.2022




EU/1/17/1242


Ritonavir Mylan


Norway


30.8.2022




EU/1/17/1244


Tacforius


Iceland


15.8.2022




EU/1/17/1244


Tacforius


Liechtenstein


31.8.2022




EU/1/17/1244


Tacforius


Norway


25.8.2022




EU/1/17/1245


Prevymis


Liechtenstein


31.8.2022




EU/1/17/1245


Prevymis


Norway


13.9.2022




EU/1/17/1246


Mvasi


Iceland


18.10.2022




EU/1/17/1246


Mvasi


Liechtenstein


30.9.2022




EU/1/17/1246


Mvasi


Norway


13.10.2022




EU/1/17/1247


Adynovi


Liechtenstein


30.11.2022




EU/1/17/1247


Adynovi


Norway


6.12.2022




EU/1/17/1249


Darunavir Krka


Liechtenstein


30.11.2022




EU/1/17/1249


Darunavir Krka


Norway


8.12.2022




EU/1/17/1251


Ozempic


Iceland


12.10.2022




EU/1/17/1251


Ozempic


Liechtenstein


30.9.2022




EU/1/17/1251


Ozempic


Norway


27.9.2022




EU/1/17/1252


Fasenra


Iceland


7.10.2022




EU/1/17/1252


Fasenra


Liechtenstein


30.9.2022




EU/1/17/1252


Fasenra


Norway


26.9.2022




EU/1/17/1254


Jorveza


Iceland


13.10.2022




EU/1/17/1254


Jorveza


Liechtenstein


30.9.2022




EU/1/17/1254


Joveza


Norway


27.9.2022




EU/1/17/1255


Intrarosa


Iceland


10.10.2022




EU/1/17/1255


Intrarosa


Liechtenstein


30.9.2022




EU/1/17/1255


Intrarosa


Norway


20.9.2022




EU/1/17/1256


Anagrelide Mylan


Iceland


12.12.2022




EU/1/17/1256


Anagrelide Mylan


Liechtenstein


30.11.2022




EU/1/17/1256


Anagrelide Mylan


Norway


8.12.2022




EU/1/17/1257


Herzuma


Liechtenstein


31.12.2022




EU/1/17/1257


Herzuma


Norway


9.12.2022




EU/1/17/1260


Alkindi


Iceland


5.12.2022




EU/1/17/1260


Alkindi


Liechtenstein


30.11.2022




EU/1/17/1260


Alkindi


Norway


6.12.2022




EU/1/17/1263


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka


Iceland


5.12.2022




EU/1/17/1263


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka


Liechtenstein


30.11.2022




EU/1/17/1263


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka


Norway


6.12.2022




EU/1/18/1265


Segluromet


Iceland


5.12.2022




EU/1/18/1265


Segluromet


Liechtenstein


30.11.2022




EU/1/18/1265


Segluromet


Norway


6.12.2022




EU/1/18/1266


Steglujan


Iceland


14.12.2022




EU/1/18/1266


Steglujan


Liechtenstein


31.12.2022




EU/1/18/1266


Steglujan


Norway


5.12.2022




EU/1/18/1267


Steglatro


Iceland


8.12.2022




EU/1/18/1267


Steglatro


Liechtenstein


30.11.2022




EU/1/18/1267


Steglatro


Norway


23.11.2022




EU/1/18/1271


Hemlibra


Iceland


7.10.2022




EU/1/18/1271


Hemlibra


Liechtenstein


30.9.2022




EU/1/18/1271


Hemlibra


Norway


20.9.2022




EU/1/18/1272


Shingrix


Iceland


14.12.2022




EU/1/18/1272


Shingrix


Liechtenstein


31.12.2022




EU/1/18/1272


Shingrix


Norway


5.12.2022




EU/1/18/1274


Trydonis


Liechtenstein


31.12.2022




EU/1/18/1275


Riarify


Liechtenstein


31.12.2022




EU/1/18/1275


Riarify


Norway


9.12.2022




EU/1/18/1277


Mylotarg


Iceland


8.12.2022




EU/1/18/1277


Mylotarg


Liechtenstein


30.11.2022




EU/1/18/1277


Mylotarg


Norway


8.12.2022




EU/1/18/1280


Zessly


Iceland


14.12.2022




EU/1/18/1280


Zessly


Liechtenstein


30.11.2022




EU/1/18/1280


Zessly


Norway


28.11.2022




EU/1/19/1355


Lorviqua


Norway


16.8.2022




EU/1/19/1376


Libtayo


Iceland


14.7.2022




EU/1/19/1376


Libtayo


Norway


28.7.2022




EU/1/19/1376


Libtayo


Liechtenstein


31.7.2022




EU/1/19/1385


Vitrakvi


Iceland


31.8.2022




EU/1/19/1385


Vitrakvi


Liechtenstein


31.8.2022




EU/1/19/1385


Vitrakvi


Norway


12.9.2022




EU/1/20/1437


Dovprela


Iceland


12.7.2022




EU/1/20/1437


Dovprela


Norway


2.8.2022




EU/1/20/1446


Hepcludex


Iceland


18.8.2022




EU/1/20/1446


Hepcludex


Norway


16.8.2022




EU/1/20/1459


Veklury


Iceland


17.8.2022




EU/1/20/1459


Veklury


Norway


15.8.2022




EU/1/20/1460


Rozlytrek


Iceland


1.9.2022




EU/1/20/1460


Rozlytrek


Norway


16.8.2022




EU/1/20/1471


Idefirix


Iceland


21.7.2022




EU/1/20/1471


Idefirix


Liechtenstein


31.7.2022




EU/1/20/1471


Idefirix


Norway


3.11.2022




EU/1/20/1473


Ayvakyt


Iceland


30.8.2022




EU/1/20/1473


Ayvakyt


Liechtenstein


31.7.2022




EU/1/20/1473


Ayvakyt


Norway


2.8.2022




EU/1/20/1474


Blenrep


Iceland


13.7.2022




EU/1/20/1474


Blenrep


Norway


28.7.2022




EU/1/20/1476


Adakveo


Liechtenstein


31.8.2022




EU/1/20/1476


Adakveo


Norway


10.10.2022




EU/1/20/1492


Tecartus


Iceland


8.12.2022




EU/1/20/1492


Tecartus


Liechtenstein


30.11.2022




EU/1/20/1507


Spikevax


Iceland


13.10.2022




EU/1/20/1507


Spikevax


Norway


10.10.2022




EU/1/20/1507


Spikevax


Liechtenstein


31.10.2022




EU/1/20/1508


Enhertu


Liechtenstein


31.10.2022




EU/1/20/1508


Enhertu


Norway


7.12.2022




EU/1/20/1527


Retsevmo


Liechtenstein


31.12.2022




EU/1/20/1528


Comirnaty


Norway


13.10.2022




EU/1/20/1528


Comirnaty


Iceland


9.11.2022




EU/1/20/1528


Comirnaty


Liechtenstein


31.10.2022




EU/1/21/1529


Vaxzevria


Norway


4.11.2022




EU/1/21/1529


Vaxzevria


Liechtenstein


31.10.2022




EU/1/21/1537


NEXPOVIO


Iceland


25.8.2022




EU/1/21/1539


Abecma


Iceland


12.7.2022




EU/1/21/1539


Abecma


Norway


27.9.2022




EU/1/21/1552


Koselugo


Iceland


8.9.2022




EU/1/21/1555


Gavreto


Iceland


7.10.2022




EU/1/21/1555


Gavreto


Liechtenstein


30.9.2022




EU/1/21/1555


Gavreto


Norway


26.9.2022




EU/1/21/1570


Minjuvi


Iceland


15.7.2022




EU/1/21/1570


Minjuvi


Liechtenstein


31.7.2022




EU/1/21/1570


Minjuvi


Norway


3.8.2022




EU/1/21/1594


Rybrevant


Iceland


13.10.2022




EU/1/21/1594


Rybrevant


Liechtenstein


30.9.2022




EU/1/21/1594


Rybrevant


Norway


24.10.2022




EU/1/21/1603


Lumykras


Liechtenstein


30.11.2022




EU/1/21/1618


Nuvaxovid


Liechtenstein


31.10.2022




EU/1/21/1618


Nuvaxovid


Norway


11.10.2022




EU/1/22/1625


Paxlovid


Iceland


12.12.2022




EU/1/22/1625


Paxlovid


Liechtenstein


30.11.2022




EU/1/22/1625


Paxlovid


Norway


9.12.2022




EU/2/12/143


Nobivac L4


Iceland


16.9.2022




EU/2/12/143


Nobivac L4


Liechtenstein


31.7.2022




EU/2/12/143


Nobivac L4


Norway


18.8.2022




EU/2/16/197


Clynav


Liechtenstein


30.6.2022




EU/2/16/197


Clynav


Norway


16.8.2022




EU/2/17/205


CYTOPOINT


Iceland


6.10.2022




EU/2/17/206


Credelio


Iceland


6.10.2022




EU/2/17/207


Zulvac BTV


Iceland


6.10.2022




EU/2/17/209


RESPIPORC FLUpan H1N1


Iceland


6.10.2022




EU/2/17/210


Zeleris


Iceland


15.9.2022




EU/2/17/211


Prevomax


Iceland


16.9.2022




EU/2/17/211


Prevomax


Liechtenstein


31.7.2022




EU/2/17/211


Prevomax


Norway


18.8.2022




EU/2/17/212


Exzolt


Iceland


16.9.2022




EU/2/17/212


Exzolt


Liechtenstein


31.7.2022




EU/2/17/212


Exzolt


Norway


29.9.2022




EU/2/17/214


Vepured


Liechtenstein


31.7.2022




EU/2/17/214


Vepured


Norway


25.8.2022




EU/2/17/215


Suvaxyn PRRS MLV


Iceland


16.9.2022




EU/2/17/215


Suvaxyn PRRS MLV


Liechtenstein


31.7.2022




EU/2/17/215


Suvaxyn PRRS MLV


Norway


18.8.2022




EU/2/17/218


Bovilis Blue-8


Liechtenstein


31.10.2022




EU/2/17/218


Bovilis Blue-8


Norway


25.10.2022




EU/2/17/223


Suvaxyn Circo


Norway


22.7.2022




EU/2/19/245


Gumbohatch


Norway


11.10.2022




EU/2/20/269


Solensia


Iceland


16.9.2022




EU/2/20/269


Solensia


Norway


7.9.2022




EU/2/21/273


Bonqat


Norway


9.11.2022






(1)  Authorisation was unintentionally omitted from the list for the 1st half of 2022.





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 2022:








EU-Number


Product


Country


Date of authorisation




EU/1/13/861/003-004


Procysbi


Iceland


23.8.2022




EU/1/13/861/003-004


Procysbi


Norway


17.8.2022




EU/1/15/1061


Genvoya


Norway


3.10.2022




EU/1/15/1061/003-004


Genvoya


Iceland


13.10.2022




EU/1/17/1217/004


Nitisinone MDK


Norway


16.8.2022




EU/1/17/1229


Dupixent


Norway


13.10.2022




EU/1/17/1229/021-022


Dupixent


Norway


16.8.2022




EU/1/18/1289/005-006


Biktavry


Norway


9.12.2022




EU/1/18/1289/005-006


Biktavry


Iceland


14.12.2022




EU/1/19/1361/004-005


Skyrizi


Norway


8.12.2022




EU/1/19/1404/010-011


Rinvoq


Iceland


16.8.2022




EU/1/19/1404/010-011


Rinvoq


Norway


16.8.2022




EU/1/20/1500/003


Xofluza


Iceland


6.9.2022




EU/1/20/1507/002-003


Spikevax


Norway


16.8.2022




EU/1/20/1507/004-005


Spikevax bivalent Original/Omicron BA.1


Norway


01.09.2022




EU/1/20/1507/002-003


Spikevax


Iceland


1.9.2022




EU/1/20/1507/006


Spikevax bivalent Original/Omicron BA.4-5


Norway


20.10.2022




EU/1/20/1507/007-008


Spikevax bivalent Original/Omicron BA.1


Norway


20.10.2022




EU/1/20/1507/009-010


Spikevax bivalent Original/Omicron BA.4-5


Norway


19.12.2022




EU/1/20/1528/006 -007


Comirnaty Original/Omicron BA.1


Norway


1.9.2022




EU/1/20/1528/008 -009


Comirnaty Original/Omicron BA. 4-5


Norway


12.9.2022




EU/1/20/1528/010


Comirnaty


Norway


20.10.2022




EU/1/20/1528/010


Comirnaty


Iceland


3.11.2022




EU/1/20/1528/011 - 012


Comirnaty Original/Omicron BA. 4-5


Norway


11.11.2022




EU/1/20/1528/011-012


Comirnaty Original/Omicron BA.4-5


Iceland


8.12.2022




EU/1/20/1528/013


Comirnaty


Norway


22.12.2022




EU/1/20/1528/014


Comirnaty Original/Omicron BA. 4-5


Norway


22.12.2022




EU/2/10/111/009-017


Meloxoral


Iceland


15.12.2022




EU/2/10/111/009-017


Meloxoral


Norway


30.11.2022









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 2022:








EU-Number


Product


Country


Date of withdrawal




EU/1/00/166


NeuroBloc


Liechtenstein


31.12.2022




EU/1/00/166


NeuroBloc


Norway


31.12.2022




EU/1/01/174


Starlix


Iceland


17.8.2022




EU/1/03/251


Hepsera


Iceland


12.12.2022




EU/1/03/251


Hepsera


Liechtenstein


30.11.2022




EU/1/03/251


Hepsera


Norway


12.12.2022




EU/1/07/384


Docetaxel Zentiva


Norway


13.9.2022




EU/1/07/421


Glubrava


Iceland


1.9.2022




EU/1/08/498


Thymanax


Iceland


13.7.2022




EU/1/08/498


Thymanax


Liechtenstein


31.7.2022




EU/1/08/498


Thymanax


Norway


21.9.2022




EU/1/10/616


Temozolomide HEXAL


Liechtenstein


30.9.2022




EU/1/10/617


Temozolomide Sandoz


Liechtenstein


30.9.2022




EU/1/10/617


Temozolomide Sandoz


Norway


27.10.2022




EU/1/13/825


Imatinib Actavis


Iceland


1.9.2022




EU/1/13/825


Imatinib Actavis


Norway


14.7.2022




EU/1/15/1042


Zalviso


Iceland


17.8.2022




EU/1/15/1042


Zalviso


Liechtenstein


31.8.2022




EU/1/15/1042


Zalviso


Norway


13.9.2022




EU/1/15/1069


Episalvan


Norway


21.9.2022




EU/1/19/1359


Trogarzo


Liechtenstein


31.12.2022




EU/1/19/1378


Temybric Ellipta


Liechtenstein


31.8.2022




EU/1/19/1378


Temybric Ellipta


Norway


26.10.2022




EU/1/19/1387


Senstend


Iceland


25.8.2022




EU/1/19/1387


Senstend


Norway


21.9.2022




EU/2/02/036


Nobilis OR inac


Liechtenstein


30.9.2022




EU/2/02/036


Nobilis OR inac


Norway


14.10.2022




EU/2/10/106


Bovilis BTV8


Liechtenstein


31.8.2022




EU/2/10/106


Bovilis BTV8


Norway


14.9.2022




EU/2/11/137


Activyl Tick Plus


Liechtenstein


30.9.2022




EU/2/11/137


Activyl Tick Plus


Norway


25.10.2022









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 2022:








EU-Number


Product


Country


Date of suspension