Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2021 2022/C 306/05 Subcommittee I on the free movement of goods (Text with EEA relevance)
Date: 2022-08-11
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_2022306EN.01002201.xml










11.8.2022   


EN


Official Journal of the European Union


C 306/22






Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2021
(2022/C 306/05)
Subcommittee I on the free movement of goods
(Text with EEA relevance)
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 2021 at their meeting on 18 March 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List of withdrawn marketing authorisations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 July – 31 December 2021:








EU-Number


Product


Country


Date of authorisation




EU/1/21/1539


Abecma


Norway


23.08.2021




EU/1/21/1539


Abecma


Liechtenstein


31.08.2021




EU/1/21/1539


Abecma


Iceland


30.8.2021




EU/1/21/1553


Abiraterone Krka


Iceland


13.7.2021




EU/1/21/1571


Abiraterone Mylan


Norway


07.09.2021




EU/1/21/1571


Abiraterone Mylan


Liechtenstein


31.08.2021




EU/1/21/1571


Abiraterone Mylan


Iceland


2.9.2021




EU/1/21/1554


Adtralza


Iceland


12.7.2021




EU/1/21/1582


Artesunate Amivas


Norway


17.12.2021




EU/1/21/1582


Artesunate Amivas


Liechtenstein


31.12.2021




EU/1/21/1582


Artesunate Amivas


Iceland


15.12.2021




EU/1/21/1595


Aspaveli


Norway


16.12.2021




EU/1/21/1595


Aspaveli


Liechtenstein


31.12.2021




EU/1/21/1595


ASPAVELI


Iceland


30.12.2021




EU/1/21/1575


Bimzelx


Norway


30.08.2021




EU/1/21/1575


Bimzelx


Liechtenstein


31.08.2021




EU/1/21/1575


Bimzelx


Iceland


1.9.2021




EU/2/21/273


Bonqat


Norway


05.08.2021




EU/2/21/273


Bonqat


Liechtenstein


31.08.2021




EU/2/21/273


Bonqat


Iceland


23.8.2021




EU/1/21/1576


Brukinsa


Norway


29.11.2021




EU/1/21/1576


Brukinsa


Liechtenstein


31.12.2021




EU/1/21/1576


Brukinsa


Iceland


14.12.2021




EU/1/21/1566


Bylvay


Norway


05.08.2021




EU/1/21/1566


Bylvay


Liechtenstein


31.08.2021




EU/1/21/1566


Bylvay


Iceland


24.8.2021




EU/1/21/1572


Byooviz


Norway


07.09.2021




EU/1/21/1572


Byooviz


Liechtenstein


31.08.2021




EU/1/21/1572


Byooviz


Iceland


3.9.2021




EU/1/21/1560


Celsunax


Liechtenstein


31.08.2021




EU/1/21/1560


Celsunax


Iceland


9.7.2021




EU/1/21/1593


Cibingo


Norway


15.12.2021




EU/2/21/1593


Cibinqo


Liechtenstein


31.12.2021




EU/1/21/1593


Cibinqo


Iceland


30.12.2021




EU/1/21/1559


Enspryng


Norway


06.07.2021




EU/1/21/1559


Enspryng


Iceland


15.7.2021




EU/1/21/1551


Evkeeza


Iceland


20.7.2021




EU/1/21/1574


Evrenzo


Norway


23.08.2021




EU/1/21/1574


Evrenzo


Liechtenstein


31.08.2021




EU/1/21/1574


Evrenzo


Iceland


30.8.2021




EU/2/21/275


FATROVAX RHD


Norway


23.08.2021




EU/2/21/275


FATROVAX RHD


Liechtenstein


31.08.2021




EU/2/21/275


FATROVAX RHD


Iceland


20.10.2021




EU/2/21/277


Felpreva


Norway


16.11.2021




EU/2/21/277


Felpreva


Liechtenstein


31.12.2021




EU/2/21/277


Felpreva


Iceland


1.12.2021




EU/1/21/1573


Fingolid Mylan


Liechtenstein


31.08.2021




EU/1/21/1573


Fingolimod Mylan


Norway


07.09.2021




EU/1/21/1573


Fingolimod Mylan


Iceland


2.9.2021




EU/1/21/1555


Gavreto


Norway


22.12.2021




EU/1/21/1555


Gavreto


Liechtenstein


31.12.2021




EU/1/21/1555


GAVRETO


Iceland


14.12.2021




EU/1/21/1589


Hukyndra


Norway


18.11.2021




EU/1/21/1589


Hukyndra


Liechtenstein


31.12.2021




EU/1/21/1589


Hukyndra


Iceland


10.12.2021




EU/1/21/1567


Icatibant Accord


Norway


05.08.2021




EU/1/21/1567


Icatibant Accord


Liechtenstein


31.08.2021




EU/1/21/1567


Icatibant Accord


Iceland


23.8.2021




EU/1/21/1568


Imatinib Koanaa


Norway


27.09.2021




EU/1/21/1568


Imatinib Koanaa


Liechtenstein


31.10.2021




EU/1/21/1568


Imatinib Koanaa


Iceland


15.10.2021




EU/1/21/1564


Imcivree


Norway


05.08.2021




EU/1/21/1564


Imcivree


Liechtenstein


31.08.2021




EU/1/21/1564


IMCIVREE


Iceland


21.7.2021




EU/2/21/280


Imoxat


Liechtenstein


31.12.2021




EU/2/21/280


Imoxat


Iceland


21.12.2021




EU/1/21/1557


Jayempi


Iceland


20.7.2021




EU/1/21/1558


Klisyri


Norway


05.08.2021




EU/1/21/1558


Klisyri


Liechtenstein


31.08.2021




EU/1/21/1558


Klisyri


Iceland


21.7.2021




EU/1/21/1552


Koselugo


Iceland


20.7.2021




EU/1/21/1590


Libmyris


Norway


18.11.2021




EU/1/21/1590


Libmyris


Liechtenstein


31.12.2021




EU/1/21/1590


Libmyris


Iceland


8.12.2021




EU/1/21/1570


Minjuvi


Norway


07.09.2021




EU/1/21/1570


Minjuvi


Liechtenstein


31.08.2021




EU/1/21/1570


Minjuvi


Iceland


6.9.2021




EU/1/21/1581


Nuvaxovid


Norway


20.12.2021




EU/1/21/1581


Nuvaxovid


Liechtenstein


31.12.2021




EU/1/21/1618


Nuvaxovid


Iceland


31.12.2021




EU/1/21/1556


Onureg


Liechtenstein


31.08.2021




EU/1/21/1556


Onureg


Iceland


20.7.2021




EU/1/21/1546


Ozawade


Norway


08.09.2021




EU/1/21/1546


Ozawade


Liechtenstein


31.08.2021




EU/1/21/1546


Ozawade


Iceland


6.9.2021




EU/1/21/1569


Qinlock


Liechtenstein


31.12.2021




EU/1/21/1569


Qinlock


Iceland


14.12.2021




EU/1/21/1597


Regkirona


Norway


12.11.2021




EU/1/21/1597


Regkirona


Liechtenstein


31.12.2021




EU/1/21/1597


Regkirona


Iceland


26.11.2021




EU/1/21/1588


Rivaroxaban Mylan


Norway


09.12.2021




EU/1/21/1588


Rivaroxaban Mylan


Liechtenstein


31.12.2021




EU/1/21/1588


Rivaroxaban Mylan


Iceland


8.12.2021




EU/1/21/1601


Ronapreve


Norway


12.11.2021




EU/1/21/1601


Ronapreve


Liechtenstein


31.12.2021




EU/1/21/1601


Ronapreve


Iceland


26.11.2021




EU/1/21/1594


Rybrevant


Norway


15.12.2021




EU/1/21/1594


Rybrevant


Liechtenstein


31.12.2021




EU/1/21/1594


Rybrevant


Iceland


30.12.2021




EU/1/21/1565


Ryeqo


Norway


05.08.2021




EU/1/21/1565


Ryeqo


Liechtenstein


31.08.2021




EU/1/21/1565


Ryeqo


Iceland


31.8.2021




EU/1/21/1598


Sitagiptin SUN


Liechtenstein


31.12.2021




EU/1/21/1598


Sitagliptin SUN


Iceland


30.12.2021




EU/1/21/1563


Skysona


Norway


05.08.2021




EU/1/21/1563


Skysona


Liechtenstein


31.08.2021




EU/1/21/1563


Skysona


Iceland


25.8.2021




EU/2/20/269


Solensia


Iceland


25.8.2021




EU/2/21/274


Strangvac


Norway


23.08.2021




EU/2/21/274


Strangvac


Liechtenstein


31.08.2021




EU/2/21/274


Strangvac


Iceland


30.8.2021




EU/1/21/1583


Sugammadex Mylan


Liechtenstein


31.12.2021




EU/1/21/1583


Sugammadex Mylan


Iceland


10.12.2021




EU/1/21/1583


Sugammadex Mylan,


Norway


14.12.2021




EU/2/21/278


Suiseng Diff/A


Norway


16.12.2021




EU/2/21/278


Suiseng Diff/A


Liechtenstein


31.12.2021




EU/2/21/278


Suiseng Diff/A


Iceland


17.12.2021




EU/2/21/276


Tessie


Norway


23.08.2021




EU/2/21/276


Tessie


Liechtenstein


31.08.2021




EU/2/21/276


Tessie


Iceland


27.8.2021




EU/1/21/1592


Trodelvy


Norway


29.11.2021




EU/1/21/1592


Trodelvy


Liechtenstein


31.12.2021




EU/1/21/1592


Trodelvy


Iceland


7.12.2021




EU/1/21/1591


Vaxneuvance


Norway


16.12.2021




EU/1/21/1591


Vaxneuvance


Liechtenstein


31.12.2021




EU/1/21/1591


Vaxneuvance


Iceland


31.12.2021




EU/1/21/1561


Verquvo


Norway


05.08.2021




EU/1/21/1561


Verquvo


Liechtenstein


31.08.2021




EU/1/21/1561


Verquvo


Iceland


24.8.2021




EU/1/21/1577


Voxzogo


Norway


07.09.2021




EU/1/21/1577


Voxzogo


Liechtenstein


31.08.2021




EU/1/21/1577


Voxzogo


Iceland


2.9.2021




EU/1/21/1585


Vumerity


Norway


23.11.2021




EU/1/21/1585


Vumerity


Liechtenstein


31.12.2021




EU/1/21/1585


Vumerity


Iceland


1.12.2021




EU/1/21/1562


Xevudy


Norway


17.12.2021




EU/1/21/1562


Xevudy


Liechtenstein


31.12.2021




EU/1/21/1562


Xevudy


Iceland


31.12.2021




EU/2/21/279


Zenalpha


Liechtenstein


31.12.2021




EU/2/21/279


Zenalpha


Iceland


31.12.2021









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 2021:








EU-Number


Product


Country


Date of authorisation




EU/1/20/1476


Adakveo


Liechtenstein


31.10.2021




EU/1/20/1476


Adakveo


Iceland


18.10.2021




EU/1/20/1476


Adakveo


Norway


06.10.2021




EU/1/12/794


Adcetris


Liechtenstein


31.10.2021




EU/1/12/794


ADCETRIS


Iceland


15.10.2021




EU/1/12/794


Adcetris


Norway


24.11.2021




EU/1/16/1158


Afstyla


Liechtenstein


31.08.2021




EU/1/16/1158


Afstyla


Iceland


3.9.2021




EU/1/16/1158


Afstyla


Norway


27.08.2021




EU/1/16/1164


Amgevita


Liechtenstein


31.12.2021




EU/1/16/1164


Amgevita


Iceland


30.12.2021




EU/1/16/1164


Amgevita


Norway


15.12.2021




EU/1/16/1092


Amlodipine/Valsartan Mylan


Norway


18.08.2021




EU/1/20/1473


Ayvakyt


Liechtenstein


31.08.2021




EU/1/20/1473


AYVAKYT


Iceland


26.8.2021




EU/1/20/1473


Ayvakyt


Norway


31.08.2021




EU/1/20/1474


Blenprep


Norway


06.07.2021




EU/1/20/1474


Blenrep


Iceland


12.7.2021




EU/1/16/1102


Bortezomib SUN


Iceland


13.7.2021




EU/2/16/200


Cepedex


Liechtenstein


31.12.2021




EU/2/16/200


Cepedex


Iceland


3.12.2021




EU/2/16/200


Cepedex


Norway


06.12.2021




EU/1/16/1110


Chenodeoxycholic acid Leadiant


Liechtenstein


31.12.2021




EU/1/16/1110


Chenodeoxycholic acid Leadiant


Iceland


30.12.2021




EU/1/16/1110


Chenodeoxycholic acid Leadiant


Norway


15.12.2021




EU/2/16/202


Coliprotec F4/F18


Liechtenstein


31.12.2021




EU/2/16/202


Coliprotec F4/F18


Iceland


8.12.2021




EU/2/16/202


Coliprotec F4/F18


Norway


22.12.2021




EU/1/13/890


Cometriq


Liechtenstein


31.10.2021




EU/1/13/890


Cometriq


Iceland


19.10.2021




EU/1/13/890


Cometriq


Norway


18.08.2021




EU/1/13/890


Cometriq


Norway


16.11.2021




EU/1/20/1528


Comirnaty


Liechtenstein


31.12.2021




EU/1/20/1528


Comirnaty


Iceland


5.11.2021




EU/1/20/1528


Comirnaty


Norway


20.12.2021




EU/1/17/1262


Crysvita


Norway


30.08.2021




EU/1/15/1049


Cystadrops


Liechtenstein


31.10.2021




EU/1/15/1049


CYSTADROPS


Iceland


14.10.2021




EU/1/15/1049


Cystadrops


Norway


15.09.2021




EU/1/17/1175


Daptomycin Hospira


Liechtenstein


31.12.2021




EU/1/16/1140


Darunavir Mylan


Liechtenstein


31.10.2021




EU/1/16/1140


Darunavir Mylan


Iceland


15.10.2021




EU/1/16/1140


Darunavir Mylan


Norway


30.09.2021




EU/1/13/875


Deltyba


Norway


18.08.2021




EU/1/20/1437


Dovprela


Liechtenstein


31.08.2021




EU/1/20/1437


Dovprela


Iceland


21.7.2021




EU/1/20/1437


Dovprela


Norway


05.08.2021




EU/1/16/1133


Emitricitabine/Tenofovir disoproxil Mylan


Norway


06.10.2021




EU/1/16/1088


Empliciti


Norway


18.08.2021




EU/1/16/1151


Emtricitabine/Tenofovir disoproxil Krka


Iceland


12.10.2021




EU/1/16/1151


Emtricitabine/Tenofovir disoproxil Krka


Norway


27.09.2021




EU/1/16/1133


Emtricitabine/Tenofovir disoproxil Mylan


Iceland


18.10.2021




EU/1/16/1148


Emtricitabine/Tenofovir disoproxil Zentiva


Liechtenstein


31.08.2021




EU/1/16/1148


Emtricitabine/Tenofovir disoproxil Zentiva


Iceland


25.8.2021




EU/1/16/1148


Emtricitabine/Tenofovir disoproxil Zentiva


Norway


05.08.2021




EU/1/16/1151


Emtricitabine/Tenofovir disproxil Krka


Liechtenstein


31.10.2021




EU/1/16/1133


Emtricitabine/Tenofovir disproxil Mylan


Liechtenstein


31.10.2021




EU/1/20/1508


Enhertu


Liechtenstein


31.12.2021




EU/1/20/1508


Enhertu


Iceland


8.12.2021




EU/1/20/1508


Enhertu


Norway


14.12.2021




EU/2/16/199


Eravac


Liechtenstein


31.08.2021




EU/2/16/199


Eravac


Iceland


27.8.2021




EU/2/16/199


Eravac


Norway


30.08.2021




EU/1/13/848


Erivedge


Liechtenstein


31.08.2021




EU/1/13/848


Erivedge


Iceland


15.7.2021




EU/1/13/848


Erivedge


Norway


07.07.2021




EU/1/16/1160


Fiasp


Liechtenstein


31.08.2021




EU/1/16/1160


Fiasp


Iceland


31.8.2021




EU/1/16/1160


Fiasp


Norway


25.08.2021




EU/1/16/1146


Glyxambi


Liechtenstein


31.08.2021




EU/1/16/1146


Glyxambi


Iceland


6.9.2021




EU/1/16/1146


Glyxambi


Norway


06.09.2021




EU/1/16/1137


Granpidam


Liechtenstein


31.08.2021




EU/1/16/1137


Granpidam


Iceland


2.9.2021




EU/16/1137


Granpidam


Norway


08.09.2021




EU/2/16/201


Halagon


Liechtenstein


31.10.2021




EU/2/16/201


Halagon


Iceland


13.10.2021




EU/2/16/201


Halagon


Norway


16.12.2021




EU/1/20/1446


Hepcludex


Liechtenstein


31.08.2021




EU/1/20/1446


Hepcludex


Iceland


27.8.2021




EU/1/20/1446


Hepcludex


Norway


23.08.2021




EU/1/14/987


Holoclar


Norway


18.08.2021




EU/1/16/1147


Ibrance


Liechtenstein


31.08.2021




EU/1/16/1147


Ibrance


Iceland


24.8.2021




EU/1/16/1147


Ibrance


Norway


05.08.2021




EU/1/20/1471


Idefirix


Liechtenstein


31.08.2021




EU/1/20/1471


Idefirix


Iceland


24.8.2021




EU/1/20/1471


Idefirix


Norway


06.09.2021




EU/1/21/1564


Imcivree


Liechtenstein


31.08.2021




EU/1/16/1132


Inhixa


Liechtenstein


31.08.2021




EU/1/16/1132


Inhixa


Iceland


2.9.2021




EU/1/16/1132


Inhixa


Norway


06.09.2021




EU/1/16/1144


Ivabradine Zentiva


Liechtenstein


31.10.2021




EU/1/16/1144


Ivabradine Zentiva


Iceland


18.10.2021




EU/1/16/1144


Ivabradine Zentiva


Norway


07.10.2021




EU/1/16/1128


Kisplyx


Iceland


12.7.2021




EU/1/16/1161


Movymia


Liechtenstein


31.10.2021




EU/1/16/1161


Movymia


Iceland


15.10.2021




EU/1/16/1161


Movymia


Norway


28.09.2021




EU/1/16/1134


Mysildecard


Liechtenstein


31.10.2021




EU/1/16/1134


Mysildecard


Iceland


15.9.2021




EU/1/16/1134


Mysildecard


Norway


27.09.2021




EU/1/16/1094


Ninlaro


Liechtenstein


31.12.2021




EU/1/16/1094


Ninlaro


Iceland


17.12.2021




EU/1/16/1094


Ninlaro


Norway


15.12.2021




EU/1/16/1124


Nordimet


Iceland


13.7.2021




EU/1/16/1170


Olumiant


Liechtenstein


31.12.2021




EU/1/16/1170


OLUMIANT


Iceland


8.12.2021




EU/1/16/1170


Olumiant


Norway


19.11.2021




EU/1/16/1130


Onivyde pegylated liposomal


Liechtenstein


31.08.2021




EU/1/16/1130


Onivyde pegylated liposomal


Iceland


25.8.2021




EU/1/16/1130


Onivyde pegylated liposomal


Norway


17.08.2021




EU/1/16/1142


Parsabiv


Liechtenstein


31.10.2021




EU/1/16/1142


Parsabiv


Iceland


13.10.2021




EU/1/16/1142


Parsabiv


Norway


27.09.2021




EU/1/19/1388


Polivy


Liechtenstein


31.12.2021




EU/1/19/1388


Polivy


Iceland


17.12.2021




EU/1/19/1388


Polivy


Norway


22.12.2021




EU/1/16/1166


Pregabalin Zentiva k.s


Liechtenstein


31.12.2021




EU/1/16/1166


Pregabalin Zentiva k.s.


Iceland


15.12.2021




EU/1/16/1166


Pregabalin Zentiva k.s.


Norway


29.11.2021




EU/1/16/1150


Rekovelle


Liechtenstein


31.08.2021




EU/1/16/1150


REKOVELLE


Iceland


24.8.2021




EU/1/16/1150


Rekovelle


Norway


05.08.2021




EU/1/20/1527


Retsevmo


Liechtenstein


31.12.2021




EU/1/20/1460


Rozlytrek


Iceland


13.7.2021




EU/1/20/1460


Rozlytrek


Norway


06.07.2021




EU/2/16/198


Sedadex


Liechtenstein


31.08.2021




EU/2/16/198


Sedadex


Iceland


3.9.2021




EU/2/16/198


Sedadex


Norway


06.09.2021




EU/1/16/1135


Sialanar


Iceland


13.7.2021




EU/1/16/1141


SomaKit TOC


Liechtenstein


31.12.2021




EU/1/16/1141


SomaKit TOC


Iceland


8.12.2021




EU/1/16/1141


SomaKit TOC


Norway


23.11.2021




EU/1/20/1507


Spikevax


Liechtenstein


31.10.2021




EU/1/20/1507


Spikevax


Iceland


27.10.2021




EU/1/20/1507


Spikevax


Norway


05.10.2021




EU/2/16/204


Stronghold Plus


Liechtenstein


31.12.2021




EU/2/16/204


Stronghold Plus


Iceland


21.12.2021




EU/2/16/204


Stronghold Plus


Norway


17.12.2021




EU/1/16/1157


Suliqua


Liechtenstein


31.12.2021




EU/1/16/1157


Suliqua


Iceland


14.12.2021




EU/1/16/1157


Suliqua


Norway


22.12.2021




EU/17/1177


Tadalafil Lilly


Liechtenstein


31.12.2021




EU/1/17/1177


Tadalafil Lilly


Iceland


3.12.2021




EU/1/17/1177


Tadalafil Lilly


Norway


19.11.2021




EU/1/16/1153


Talmanco


Liechtenstein


31.12.2021




EU/1/16/1153


Talmanco


Iceland


7.12.2021




EU/1/16/1153


Talmanco


Norway


06.12.2021




EU/1/20/1492


Tecartus


Iceland


15.12.2021




EU/1/20/1492


Tecartus


Liechtenstein


31.12.2021




EU/1/20/1492


Tecartus


Norway


16.12.2021




EU/1/16/1129


Tenofovir disoproxil Mylan


Liechtenstein


31.08.2021




EU/1/16/1129


Tenofovir disoproxil Mylan


Iceland


1.9.2021




EU/1/16/1129


Tenofovir disoproxil Mylan


Norway


06.09.2021




EU/1/16/1127


Tenofovir disoproxil Zentiva


Liechtenstein


31.08.2021




EU/1/16/1127


Tenofovir disoproxil Zentiva


Iceland


25.8.2021




EU/1/16/1127


Tenofovir disoproxil Zentiva


Norway


05.08.2021




EU/1/16/1159


Terrosa


Liechtenstein


31.10.2021




EU/1/16/1159


Terrosa


Iceland


14.10.2021




EU/1/16/1159


Terrosa


Norway


05.10.2021




EU/1/13/902


Translarna


Iceland


13.7.2021




EU/1/13/902


Translarna


Norway


06.07.2021




EU/1/16/1167


Truxima


Liechtenstein


31.12.2021




EU/1/16/1167


Truxima


Iceland


1.12.2021




EU/1/16/1167


Truxima


Norway


19.11.2021




EU/1/21/1529


Vaxzevria


Liechtenstein


31.12.2021




EU/1/21/1529


Vaxzevria


Iceland


8.12.2021




EU/1/21/1529


Vaxzevria


Norway


15.11.2021




EU/1/20/1459


Veklury


Iceland


13.7.2021




EU/1/20/1459


Veklury


Norway


05.07.2021




EU/1/16/1168


Vihuma


Liechtenstein


31.10.2021




EU/1/16/1168


Vihuma


Iceland


18.10.2021




EU/1/16/1168


Vihuma


Norway


30.09.2021




EU/1/19/1385


Vitrakvi


Liechtenstein


31.08.2021




EU/1/19/1385


VITRAKVI


Iceland


31.8.2021




EU/1/19/1385


Vitrakvi


Norway


23.08.2021




EU/1/15/1068


Wakix


Norway


18.08.2021




EU/1/12/793


Xalkori


Liechtenstein


31.08.2021




EU/1/12/793


XALKORI


Iceland


24.8.2021




EU/1/12/793


Xalkori


Norway


05.08.2021




EU/1/16/1156


Zinplava


Liechtenstein


31.10.2021




EU/1/16/1156


Zinplava


Iceland


16.9.2021




EU/1/16/1156


Zinplava


Norway


08.09.2021




EU/1/19/1367


Zynteglo


Liechtenstein


31.10.2021




EU/1/19/1367


Zynteglo


Iceland


19.10.2021




EU/1/19/1367


Zynteglo


Norway


29.09.2021









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 2021:








EU-Number


Product


Country


Date of authorisation




EU/1/15/1001/004


Akynzeo


Iceland


8.12.2021




EU/1/15/1001/004


Akynzeo


Norway


23.11.2021




EU/2/13/154/028-033


Apoquel


Iceland


30.12.2021




EU/1/13/838/006


AUBAGIO


Iceland


26.8.2021




EU/1/15/1019/003-006


Bortezomib Accord


Iceland


31.8.2021




EU/1/15/1019/003-006


Bortezomib Accord


Norway


09.08.2021




EU/1/20/1453/007-008


BYANNLI


Iceland


22.12.2021




EU/1/20/1453/007-008


Byannli


Norway


21.12.2021




EU/1/20/1528/002-003


Comirnaty


Iceland


5.11.2021




EU/1/20/1528/004-005


Comirnaty


Iceland


29.11.2021




EU/1/14/980/012-013


Cosentyx


Iceland


25.8.2021




EU/1/14/980/008-011


Cosentyx


Norway


09.08.2021




EU/1/13/875/005


Deltyba


Iceland


15.10.2021




EU/1/13/875/005


Deltyba


Norway


27.09.2021




EU/2/11/128/004-010


Emdocam


Norway


02.07.2021




EU/1/01/188


Fabrazyme


Norway


01.07.2021




EU/1/17/1230/026-027


Lacosamide Accord


Iceland


14.12.2021




EU/1/17/1230/026-027


Lacosamide Accord


Norway


22.12.2021




EU/1/17/1213/002


Maviret


Iceland


13.7.2021




EU/1/19/1404/006-009


Rinvoq


Iceland


31.8.2021




EU/1/19/1404/006-009


Rinvoq


Norway


27.08.2021




EU/1/08/451/005


Volibris


Iceland


18.10.2021




EU/1/08/451/005


Volibris


Norway


28.09.2021




EU/1/17/1223/002


Vosevi


Iceland


11.10.2021




EU/1/17/1223/002


Vosevi


Norway


27.09.2021




EU/1/17/1178/015


XELJANZ


Iceland


31.8.2021




EU/1/17/1178/015


Xeljanz


Norway


18.08.2021









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 2021:








EU-Number


Product


Country


Date of withdrawal




EU/1/07/430


Atripla


Iceland


10.12.2021




EU/1/07/430


Atripla


Liechtenstein


31.12.2021




EU/1/07/430


Atripla


Norway


15.12.2021




EU/1/15/1081


Caspofungin Accord


Norway


15.02.2021




EU/2/14/180


Coliprotec F4


Liechtenstein


31.12.2021




EU/2/14/180


Coliprotec F4


Iceland


10.12.2021




EU/1/09/611


Docetaxel Teva


Iceland


26.10.2021




EU/1/09/611


Docetaxel Teva


Liechtenstein


31.10.2021




EU/1/09/611


Docetaxel Teva


Norway


16.12.2021




EU/1/20/1472


Equidacent


Iceland


17.11.2021




EU/1/20/1472


Equidacent


Liechtenstein


31.10.2021




EU/1/20/1472


Equidacent


Norway


15.11.2021




EU/1/12/756


Glidipion


Iceland


26.8.2021




EU/1/12/756


Glidipion


Liechtenstein


31.08.2021




EU/1/00/151


Glustin


Iceland


15.12.2021




EU/1/00/151


Glustin


Liechtenstein


31.12.2021




EU/1/00/151


Glustin


Norway


21.12.2021




EU/1/99/127


IntronA


Iceland


17.12.2021




EU/1/99/127


IntronA


Liechtenstein


31.12.2021




EU/1/99/127


IntronA


Norway


21.12.2021




EU/1/20/1516


Lextemy


Iceland


13.7.2021




EU/1/20/1516


Lextemy


Norway


01.07.2021




EU/1/20/1522


Lumoxiti


Iceland


26.8.2021




EU/1/29/1522


Lumoxiti


Liechtenstein


31.08.2021




EU/1/20/1522


Lumoxiti


Norway


23.08.2021




EU/1/04/297


Nodetrip


Iceland


12.7.2021




EU/1/00/149


Panretin


Liechtenstein


31.12.2021




EU/1/00/149/001


Panretin


Norway


06.01.2021




EU/1/09/519


Pantoloc Control


Liechtenstein


31.12.2021




EU/1/12/758


Pioglitazone Teva Pharma


Iceland


12.7.2021




EU/1/12/758


Pioglitazone Teva Pharma


Liechtenstein


31.08.2021




EU/1/12/758


Pioglitazone Teva Pharma


Norway


16.07.2021




EU/2/99/016


Porcilis Pesti


Iceland


30.8.2021




EU/2/99/016


Porcilis Pesti


Liechtenstein


31.08.2021




EU/2/99/016


Porcilis Pesti


Norway


24.08.2021




EU/1/15/1084


Portrazza


Norway


18.02.2021




EU/1/15/998


Pregabalin Mylan Pharma


Iceland


1.12.2021




EU/1/15/998


Pregabalin Mylan Pharma


Liechtenstein


31.12.2021




EU/1/15/998


Pregabalin Mylan Pharma


Norway


15.11.2021




EU/1/08/491


Rasilez HCT


Liechtenstein


31.12.2021




EU/1/09/509


Ribavirin Teva


Iceland


12.7.2021




EU/1/09/509


Ribavirin Teva


Liechtenstein


31.08.2021




EU/1/09/509


Ribavirin Teva


Norway


16.07.2021




EU/1/09/527


Ribavirin Teva Pharma B.V.


Iceland


12.7.2021




EU/1/09/527


Ribavirin Teva Pharma BV


Liechtenstein


31.08.2021




EU/1/09/527


Ribavirin Teva Pharma BV


Norway


16.07.2021




EU/1/17/1207


Ritemvia


Iceland


12.7.2021




EU/1/17/1207


Ritemvia


Liechtenstein


31.08.2021




EU/1/17/1207


Ritemvia


Norway


16.07.2021




EU/1/21/1563


Skysona


Iceland


25.8.2021




EU/1/21/1563


Skysona


Liechtenstein


31.12.2021




EU/1/21/1563


Skysona


Norway


21.12.2021




EU/2/07/074


Spironolactone Ceva


Iceland


26.8.2021




EU/2/07/074


Spironolactone Ceva


Liechtenstein


31.08.2021




EU/1/18/1309


Ulipristal Acetate Gedeon Richter


Iceland


26.8.2021




EU/1/18/1309


Ulipristal Acetate Gedeon Richter


Liechtenstein


31.08.2021




EU/1/18/1309


Ulipristal Acetate Gedeon Richter


Norway


16.07.2021




EU/1/03/250


Ytracis


Liechtenstein


31.12.2021









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 2021:








EU-Number


Product


Country


Date of suspension