Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2023
Date: 2024-07-04
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_202404358EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/4358


4.7.2024






Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2023
(C/2024/4358)


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 2023, at their meeting on 15 March 2024:







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List of withdrawn marketing authorisations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 2023:








EU-Number


Product


Country


Date of authorisation




EU/1/23/1752


Abrysvo


Iceland


6.9.2023




EU/1/23/1752


Abrysvo


Liechtenstein


31.8.2023




EU/1/23/1752


Abrysvo


Norway


9.10.2023




EU/1/23/1776


AGAMREE


Iceland


28.12.2023




EU/1/23/1776


AGAMREE


Liechtenstein


31.12.2023




EU/1/23/1776


AGAMREE


Norway


19.12.2023




EU/1/23/1722


AKEEGA


Norway


25.7.2023




EU/1/23/1760


Apretude


Iceland


16.10.2023




EU/1/23/1760


Apretude


Liechtenstein


30.9.2023




EU/1/23/1760


Apretude


Norway


9.10.2023




EU/1/23/1750


AQUIPTA


Iceland


30.8.2023




EU/1/23/1750


AQUIPTA


Liechtenstein


31.8.2023




EU/1/23/1750


AQUIPTA


Norway


29.8.2023




EU/1/23/1717


AQUMELDI


Iceland


4.12.2023




EU/1/23/1717


AQUMELDI


Liechtenstein


30.11.2023




EU/1/23/1717


AQUMELDI


Norway


20.11.2023




EU/2/23/303


Bovilis Cryptium


Liechtenstein


30.11.2023




EU/1/23/1716


Camzyos


Iceland


9.8.2023




EU/1/23/1716


Camzyos


Norway


12.7.2023




EU/1/23/1763


Catiolanze


Iceland


4.12.2023




EU/1/23/1763


Catiolanze


Liechtenstein


30.11.2023




EU/1/23/1763


Catiolanze


Norway


12.12.2023




EU/1/23/1742


Columvi


Iceland


9.8.2023




EU/1/23/1742


Columvi


Liechtenstein


31.7.2023




EU/1/23/1742


Columvi


Norway


13.7.2023




EU/1/23/1753


Degarelix Accord


Iceland


23.10.2023




EU/1/23/1753


Degarelix Accord


Liechtenstein


30.9.2023




EU/1/23/1753


Degarelix Accord


Norway


10.10.2023




EU/1/22/1711


Dimethyl Fumarate Accord


Liechtenstein


31.12.2023




EU/1/22/1634


Dimethyl fumarate Mylan


Liechtenstein


31.12.2023




EU/1/22/1637


Dimethyl fumarate Neuraxpharm


Liechtenstein


31.12.2023




EU/1/22/1635


Dimethyl fumarate Polpharma


Liechtenstein


31.12.2023




EU/1/22/1702


Dimethyl Fumarate Teva


Liechtenstein


31.12.2023




EU/1/23/1765


Ebglyss


Iceland


4.12.2023




EU/1/23/1765


Ebglyss


Liechtenstein


30.11.2023




EU/1/23/1765


Ebglyss


Norway


30.11.2023




EU/1/23/1770


ELREXFIO


Iceland


18.12.2023




EU/1/23/1770


ELREXFIO


Liechtenstein


31.12.2023




EU/1/23/1770


ELREXFIO


Norway


13.12.2023




EU/1/23/1772


Elucirem


Iceland


18.12.2023




EU/1/23/1772


Elucirem


Liechtenstein


31.12.2023




EU/1/23/1772


Elucirem


Norway


18.12.2023




EU/2/23/297


Eluracat


Iceland


9.8.2023




EU/2/23/297


Eluracat


Norway


23.8.2023




EU/1/23/1747


Enrylaze


Iceland


19.10.2023




EU/1/23/1747


Enrylaze


Liechtenstein


30.9.2023




EU/1/23/1747


Enrylaze


Norway


10.10.2023




EU/1/23/1767


Finlee


Iceland


4.12.2023




EU/1/23/1767


Finlee


Liechtenstein


30.11.2023




EU/1/23/1767


Finlee


Norway


12.12.2023




EU/1/23/1762


Herwenda


Iceland


4.12.2023




EU/1/23/1762


Herwenda


Liechtenstein


30.11.2023




EU/1/23/1762


Herwenda


Norway


12.12.2023




EU/1/23/1756


Inaqovi


Iceland


13.10.2023




EU/1/23/1756


Inaqovi


Liechtenstein


30.9.2023




EU/1/23/1756


Inaqovi


Norway


28.9.2023




EU/1/23/1738


Jaypirca


Iceland


28.11.2023




EU/1/23/1738


Jaypirca


Liechtenstein


31.10.2023




EU/1/23/1738


Jaypirca


Norway


8.11.2023




EU/1/23/1755


Litfulo


Iceland


13.10.2023




EU/1/23/1755


Litfulo


Liechtenstein


30.9.2023




EU/1/23/1755


Litfulo


Norway


9.10.2023




EU/1/23/1774


Loargys


Iceland


28.12.2023




EU/1/23/1774


Loargys


Liechtenstein


31.12.2023




EU/1/23/1774


Loargys


Norway


19.12.2023




EU/2/23/301


Loxitab


Iceland


26.10.2023




EU/2/23/301


Loxitab


Liechtenstein


31.10.2023




EU/2/23/301


Loxitab


Norway


1.11.2023




EU/1/21/1613


Lyfnua


Iceland


19.10.2023




EU/1/21/1613


Lyfnua


Liechtenstein


30.9.2023




EU/1/21/1613


Lyfnua


Norway


10.10.2023




EU/1/23/1741


Lytgobi


Iceland


9.8.2023




EU/1/23/1741


Lytgobi


Norway


11.7.2023




EU/1/23/1741


Lytgobi


Liechtenstein


31.7.2023




EU/2/23/304


Nobivac LoVo L4


Iceland


11.12.2023




EU/2/23/304


Nobivac LoVo L4


Liechtenstein


30.11.2023




EU/1/23/1737


Opfolda


Iceland


9.8.2023




EU/1/23/1737


Opfolda


Norway


12.7.2023




EU/1/23/1757


ORSERDU


Iceland


19.10.2023




EU/1/23/1757


ORSERDU


Liechtenstein


30.9.2023




EU/1/23/1757


ORSERDU


Norway


10.10.2023




EU/2/23/299


Oxmax


Iceland


26.10.2023




EU/2/23/299


Oxmax


Liechtenstein


31.10.2023




EU/2/23/299


Oxmax


Norway


26.10.2023




EU/2/23/300


Poulvac Procerta HVT-IBD


Iceland


27.11.2023




EU/2/23/300


Poulvac Procerta HVT-IBD


Liechtenstein


31.10.2023




EU/2/23/300


Poulvac Procerta HVT-IBD


Norway


26.10.2023




EU/2/23/302


Prevexxion RN+HVT


Iceland


27.11.2023




EU/2/23/302


Prevexxion RN+HVT


Liechtenstein


31.10.2023




EU/2/23/302


Prevexxion RN+HVT


Norway


24.10.2023




EU/1/23/1746


Pylclari


Iceland


16.8.2023




EU/1/23/1746


Pylclari


Liechtenstein


31.7.2023




EU/1/23/1746


Pylclari


Norway


15.8.2023




EU/1/23/1775


Rezzayo


Iceland


29.12.2023




EU/1/23/1775


Rezzayo


Liechtenstein


31.12.2023




EU/1/23/1775


Rezzayo


Norway


28.12.2023




EU/2/23/305


Senvelgo


Iceland


13.12.2023




EU/2/23/305


Senvelgo


Liechtenstein


30.11.2023




EU/2/23/305


Senvelgo


Norway


28.11.2023




EU/1/23/1739


Sugammadex Piramal


Iceland


9.8.2023




EU/1/23/1739


Sugammadex Piramal


Norway


12.7.2023




EU/1/23/1748


TALVEY


Iceland


31.8.2023




EU/1/23/1748


TALVEY


Liechtenstein


31.8.2023




EU/1/23/1748


TALVEY


Norway


29.8.2023




EU/1/23/1759


Tepkinly


Iceland


20.10.2023




EU/1/23/1759


Tepkinly


Liechtenstein


30.9.2023




EU/1/23/1759


Tepkinly


Norway


10.10.2023




EU/1/23/1758


Tevimbra


Iceland


19.10.2023




EU/1/23/1758


Tevimbra


Liechtenstein


30.9.2023




EU/1/23/1758


Tevimbra


Norway


10.10.2023




EU/1/23/1754


Tyenne


Iceland


18.10.2023




EU/1/23/1754


Tyenne


Liechtenstein


30.9.2023




EU/1/23/1754


Tyenne


Norway


23.10.2023




EU/1/23/1745


Tyruko


Iceland


20.10.2023




EU/1/23/1745


Tyruko


Liechtenstein


30.9.2023




EU/1/23/1745


Tyruko


Norway


5.10.2023




EU/1/23/1768


VANFLYTA


Iceland


28.11.2023




EU/1/23/1768


VANFLYTA


Liechtenstein


30.11.2023




EU/1/23/1768


VANFLYTA


Norway


12.12.2023




EU/1/23/1771


Veoza


Iceland


18.12.2023




EU/1/23/1771


Veoza


Liechtenstein


31.12.2023




EU/1/23/1771


Veoza


Norway


18.12.2023




EU/1/23/1773


Vueway


Iceland


18.12.2023




EU/1/23/1773


Vueway


Liechtenstein


31.12.2023




EU/1/23/1773


Vueway


Norway


15.12.2023




EU/1/23/1751


Yesafili


Iceland


19.10.2023




EU/1/23/1751


Yesafili


Liechtenstein


30.9.2023




EU/1/23/1751


Yesafili


Norway


25.10.2023




EU/1/23/1766


Yorvipath


Iceland


4.12.2023




EU/1/23/1766


Yorvipath


Liechtenstein


30.11.2023




EU/1/23/1766


Yorvipath


Norway


12.12.2023




EU/2/23/298


YURVAC RHD


Iceland


12.10.2023




EU/2/23/298


YURVAC RHD


Liechtenstein


30.9.2023




EU/2/23/298


YURVAC RHD


Norway


11.10.2023




EU/1/23/1764


Zilbrysq


Iceland


15.12.2023




EU/1/23/1764


Zilbrysq


Liechtenstein


31.12.2023




EU/1/23/1764


Zilbrysq


Norway


12.12.2023




EU/1/23/1761


Zoonotic Influenza Vaccine Seqirus


Iceland


25.10.2023




EU/1/23/1761


Zoonotic Influenza Vaccine Seqirus


Liechtenstein


31.10.2023




EU/1/23/1761


Zoonotic Influenza Vaccine Seqirus


Norway


25.10.2023




EU/1/23/1743


ZTALMY


Iceland


16.8.2023




EU/1/23/1743


ZTALMY


Liechtenstein


31.7.2023




EU/1/23/1743


ZTALMY


Norway


15.8.2023









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 2023:








EU-Number


Product


Country


Date of authorisation




EU/1/21/1539


Abecma


Norway


15.8.2023




EU/1/19/1358


AJOVY


Iceland


28.11.2023




EU/1/19/1358


AJOVY


Liechtenstein


30.11.2023




EU/1/19/1358


AJOVY


Norway


20.11.2023




EU/1/18/1264


Alunbrig


Iceland


6.9.2023




EU/1/18/1264


Alunbrig


Liechtenstein


31.7.2023




EU/1/18/1292


Apealea


Iceland


5.10.2023




EU/1/18/1292


Apealea


Liechtenstein


30.9.2023




EU/1/18/1292


Apealea


Norway


10.10.2023




EU/2/19/249


Aservo EquiHaler


Norway


22.8.2023




EU/1/19/1353


Atazanavir Krka


Iceland


28.12.2023




EU/1/19/1353


Atazanavir Krka


Liechtenstein


31.12.2023




EU/1/19/1353


Atazanavir Krka


Norway


19.12.2023




EU/1/20/1473


AYVAKYT


Iceland


14.8.2023




EU/1/20/1473


AYVAKYT


Liechtenstein


31.7.2023




EU/1/20/1473


AYVAKYT


Norway


15.8.2023




EU/1/18/1352


Besremi


Iceland


28.12.2023




EU/1/18/1352


Besremi


Liechtenstein


31.12.2023




EU/1/18/1352


Besremi


Norway


19.12.2023




EU/1/18/1339


Bevespi Aerosphere


Iceland


20.10.2023




EU/1/18/1339


Bevespi Aerosphere


Liechtenstein


30.9.2023




EU/1/18/1339


Bevespi Aerosphere


Norway


26.10.2023




EU/1/18/1314


Braftovi


Iceland


4.7.2023




EU/1/18/1314


Braftovi


Liechtenstein


30.6.2023




EU/1/18/1314


Braftovi


Norway


17.7.2023




EU/1/18/1336


Buvidal


Iceland


15.8.2023




EU/1/18/1336


Buvidal


Liechtenstein


31.7.2023




EU/1/18/1336


Buvidal


Norway


15.8.2023




EU/2/15/183


Canigen L4


Norway


8.8.2023




EU/2/22/283


Chanaxin


Norway


22.8.2023




EU/2/17/222


Clevor


Norway


22.8.2023




EU/2/18/225


Dany’s BienenWohl


Norway


16.8.2023




EU/1/18/1310


Deferiprone Lipomed


Iceland


4.7.2023




EU/1/18/1310


Deferiprone Lipomed


Norway


17.7.2023




EU/1/13/878


Defitelio


Norway


15.8.2023




EU/1/18/1333


Delstrigo


Iceland


10.8.2023




EU/1/18/1333


Delstrigo


Liechtenstein


31.7.2023




EU/1/18/1333


Delstrigo


Norway


17.7.2023




EU/1/18/1338


Dengvaxia


Iceland


31.8.2023




EU/1/18/1338


Dengvaxia


Liechtenstein


31.8.2023




EU/1/18/1338


Dengvaxia


Norway


6.9.2023




EU/1/20/1437


Dovprela


Iceland


10.8.2023




EU/1/20/1437


Dovprela


Liechtenstein


31.7.2023




EU/1/20/1437


Dovprela


Norway


15.8.2023




EU/1/18/1330


Emgality


Iceland


12.9.2023




EU/1/18/1330


Emgality


Liechtenstein


30.9.2023




EU/1/18/1330


Emgality


Norway


6.9.2023




EU/1/20/1508


Enhertu


Iceland


2.11.2023




EU/1/20/1508


Enhertu


Liechtenstein


31.10.2023




EU/1/20/1508


Enhertu


Norway


30.10.2023




EU/1/18/1342


Erleada


Iceland


20.10.2023




EU/1/18/1342


Erleada


Liechtenstein


30.9.2023




EU/1/18/1342


Erleada


Norway


26.10.2023




EU/2/22/284


Evanovo


Norway


12.12.2023




EU/1/18/1347


Febuxostat Krka


Iceland


28.12.2023




EU/1/18/1347


Febuxostat Krka


Liechtenstein


31.12.2023




EU/2/19/238


Felisecto Plus


Norway


12.12.2023




EU/2/21/277


Felpreva


Norway


18.9.2023




EU/2/19/235


Forceris


Liechtenstein


31.7.2023




EU/1/13/881


Fortacin


Iceland


20.10.2023




EU/1/13/881


Fortacin


Liechtenstein


30.9.2023




EU/1/13/881


Fortacin


Norway


25.10.2023




EU/1/18/1329


Fulphila


Iceland


18.10.2023




EU/1/18/1329


Fulphila


Liechtenstein


30.9.2023




EU/1/18/1329


Fulphila


Norway


15.9.2023




EU/1/21/1555


GAVRETO


Iceland


20.10.2023




EU/1/21/1555


GAVRETO


Liechtenstein


30.9.2023




EU/1/21/1555


GAVRETO


Norway


26.10.2023




EU/1/18/1321


Gefitinib Mylan


Iceland


10.8.2023




EU/1/18/1321


Gefitinib Mylan


Liechtenstein


30.6.2023




EU/1/18/1321


Gefitinib Mylan


Norway


17.7.2023




EU/1/22/1715


Hemgenix


Iceland


19.12.2023




EU/1/22/1715


Hemgenix


Liechtenstein


31.12.2023




EU/1/22/1715


Hemgenix


Norway


19.12.2023




EU/1/20/1446


Hepcludex


Iceland


11.8.2023




EU/1/20/1446


Hepcludex


Liechtenstein


31.7.2023




EU/1/20/1446


Hepcludex


Norway


15.8.2023




EU/1/18/1319


Hulio


Iceland


16.8.2023




EU/1/18/1319


Hulio


Liechtenstein


31.8.2023




EU/1/18/1319


Hulio


Norway


21.9.2023




EU/2/18/230


Hydrocortisone aceponate Ecuphar


Norway


22.8.2023




EU/1/19/1356


Idacio


Iceland


27.11.2023




EU/1/19/1356


Idacio


Liechtenstein


31.10.2023




EU/1/19/1356


Idacio


Norway


8.11.2023




EU/1/20/1471


Idefirix


Iceland


11.8.2023




EU/1/20/1471


Idefirix


Liechtenstein


31.7.2023




EU/1/20/1471


Idefirix


Norway


16.8.2023




EU/1/18/1323


Ilumetri


Iceland


11.8.2023




EU/1/18/1323


Ilumetri


Liechtenstein


31.7.2023




EU/1/18/1323


Ilumetri


Norway


15.8.2023




EU/2/21/280


Imoxat


Norway


15.8.2023




EU/2/20/256


Innovax-ND-ILT


Norway


1.11.2023




EU/2/18/232


Isemid


Iceland


18.12.2023




EU/2/18/232


Isemid


Liechtenstein


30.12.2023




EU/2/18/232


Isemid


Norway


12.12.2023




EU/1/18/1324


Jivi


Iceland


4.7.2023




EU/1/18/1324


Jivi


Norway


13.7.2023




EU/1/18/1302


Kigabeq


Iceland


9.8.2023




EU/1/18/1302


Kigabeq


Liechtenstein


31.7.2023




EU/1/18/1302


Kigabeq


Norway


17.7.2023




EU/1/22/1657


Kinpeygo


Iceland


11.8.2023




EU/1/22/1657


Kinpeygo


Liechtenstein


31.7.2023




EU/1/22/1657


Kinpeygo


Norway


16.8.2023




EU/1/21/1552


Koselugo


Norway


18.7.2023




EU/2/18/234


Kriptazen


Liechtenstein


30.12.2023




EU/2/18/234


Kriptazen


Norway


20.12.2023




EU/1/18/1316


Lenalidomide Accord


Iceland


29.8.2023




EU/1/18/1316


Lenalidomide Accord


Liechtenstein


31.8.2023




EU/1/18/1316


Lenalidomide Accord


Norway


24.8.2023




EU/1/21/1603


Lumykras


Iceland


29.11.2023




EU/1/21/1603


Lumykras


Liechtenstein


30.11.2023




EU/1/21/1603


Lumykras


Norway


20.11.2023




EU/1/18/1331


Luxturna


Iceland


11.8.2023




EU/1/18/1331


Luxturna


Liechtenstein


31.7.2023




EU/1/18/1331


Luxturna


Norway


15.8.2023




EU/1/18/1315


Mektovi


Iceland


4.7.2023




EU/1/18/1315


Mektovi


Norway


13.7.2023




EU/1/18/1301


Mepsevii


Iceland


15.8.2023




EU/1/18/1301


Mepsevii


Liechtenstein


31.7.2023




EU/1/18/1301


Mepsevii


Norway


15.8.2023




EU/2/20/259


MHYOSPHERE PCV ID


Norway


22.8.2023




EU/1/18/1346


Miglustat Dipharma


Iceland


29.11.2023




EU/1/18/1346


Miglustat Dipharma


Liechtenstein


30.11.2023




EU/1/18/1346


Miglustat Dipharma


Norway


11.12.2023




EU/1/21/1570


Minjuvi


Iceland


11.8.2023




EU/1/21/1570


Minjuvi


Liechtenstein


31.7.2023




EU/1/21/1570


Minjuvi


Norway


16.8.2023




EU/2/17/220


MiPet Easecto


Norway


22.8.2023




EU/1/18/1325


Namuscla


Iceland


30.8.2023




EU/1/18/1325


Namuscla


Liechtenstein


31.8.2023




EU/1/18/1325


Namuscla


Norway


14.8.2023




EU/2/19/241


NASYM


Norway


15.9.2023




EU/1/15/1078


Natpar


Norway


25.10.2023




EU/2/20/267


NexGard Combo


Norway


22.8.2023




EU/1/16/1094


Ninlaro


Iceland


12.9.2023




EU/1/16/1094


Ninlaro


Liechtenstein


30.9.2023




EU/1/16/1094


Ninlaro


Norway


6.9.2023




EU/2/20/265


Nobivac DP Plus


Norway


8.8.2023




EU/1/16/1139


Ocaliva


Iceland


29.11.2023




EU/1/16/1139


Ocaliva


Liechtenstein


30.11.2023




EU/1/16/1139


Ocaliva


Norway


12.12.2023




EU/1/18/1341


Ogivri


Iceland


23.8.2023




EU/1/18/1341


Ogivri


Liechtenstein


31.8.2023




EU/1/18/1341


Ogivri


Norway


15.8.2023




EU/1/18/1313


Pelgraz


Norway


13.7.2023




EU/1/18/1328


Pelmeg


Iceland


13.12.2023




EU/1/18/1328


Pelmeg


Liechtenstein


30.11.2023




EU/1/18/1328


Pelmeg


Norway


12.12.2023




EU/1/18/1332


Pifeltro


Iceland


10.8.2023




EU/1/18/1332


Pifeltro


Liechtenstein


31.7.2023




EU/1/18/1332


Pifeltro


Norway


17.7.2023




EU/1/18/1335


Poteligeo


Iceland


4.10.2023




EU/1/18/1335


Poteligeo


Liechtenstein


30.9.2023




EU/1/18/1335


Poteligeo


Norway


10.10.2023




EU/1/18/1291


Rizmoic


Iceland


28.11.2023




EU/1/18/1291


Rizmoic


Liechtenstein


30.11.2023




EU/1/18/1291


Rizmoic


Norway


8.11.2023




EU/1/22/1668


Roctavian


Iceland


14.8.2023




EU/1/22/1668


Roctavian


Liechtenstein


31.7.2023




EU/1/22/1668


Roctavian


Norway


16.8.2023




EU/1/20/1460


Rozlytrek


Iceland


10.8.2023




EU/1/20/1460


Rozlytrek


Liechtenstein


31.7.2023




EU/1/20/1460


Rozlytrek


Norway


8.8.2023




EU/1/18/1294


RXULTI


Norway


15.8.2023




EU/1/21/1594


Rybrevant


Iceland


15.9.2023




EU/1/21/1594


Rybrevant


Liechtenstein


30.9.2023




EU/1/21/1594


Rybrevant


Norway


25.10.2023




EU/1/18/1343


Silodosin Recordati


Iceland


29.11.2023




EU/1/18/1343


Silodosin Recordati


Liechtenstein


30.11.2023




EU/1/18/1343


Silodosin Recordati


Norway


12.12.2023




EU/1/13/901


Sirturo


Liechtenstein


30.11.2023




EU/1/13/901


Sirturo


Norway


7.12.2023




EU/1/13/901


Sirturo


Iceland


13.12.2023




EU/1/18/1318


Slenyto


Norway


15.8.2023




EU/1/22/1688


Spevigo


Iceland


20.10.2023




EU/1/22/1688


Spevigo


Liechtenstein


30.9.2023




EU/1/18/1306


Symkevi


Iceland


31.8.2023




EU/1/18/1306


Symkevi


Liechtenstein


31.8.2023




EU/1/18/1306


Symkevi


Norway


29.8.2023




EU/2/18/231


Syvazul BTV


Norway


22.8.2023




EU/1/18/1340


TAKHZYRO


Iceland


30.8.2023




EU/1/18/1340


TAKHZYRO


Liechtenstein


31.8.2023




EU/1/18/1340


TAKHZYRO


Norway


24.8.2023




EU/1/20/1492


Tecartus


Iceland


28.12.2023




EU/1/20/1492


Tecartus


Liechtenstein


31.12.2023




EU/1/13/837


Tecfidera


Iceland


19.10.2023




EU/1/13/837


Tecfidera


Liechtenstein


30.9.2023




EU/1/13/837


Tecfidera


Norway


23.10.2023




EU/1/22/1675


TECVAYLI


Iceland


11.8.2023




EU/1/22/1675


TECVAYLI


Liechtenstein


31.7.2023




EU/1/22/1675


TECVAYLI


Norway


16.8.2023




EU/2/20/252


Tulissin


Norway


22.8.2023




EU/2/18/227


UBAC


Norway


22.8.2023




EU/1/18/1334


Vaborem


Iceland


11.8.2023




EU/1/18/1334


Vaborem


Liechtenstein


31.7.2023




EU/1/18/1334


Vaborem


Norway


15.8.2023




EU/1/18/1350


Vantobra


Iceland


20.10.2023




EU/1/18/1350


Vantobra


Liechtenstein


30.9.2023




EU/1/18/1350


Vantobra


Norway


25.10.2023




EU/2/20/266


Vectormune FP ILT


Norway


18.9.2023




EU/2/20/250


Vectormune FP ILT+AE


Norway


18.9.2023




EU/1/16/1138


Venclyxto


Iceland


30.8.2023




EU/1/16/1138


Venclyxto


Liechtenstein


31.8.2023




EU/1/16/1138


Venclyxto


Norway


24.8.2023




EU/2/14/169


Versican Plus DHPPi


Norway


19.9.2023




EU/2/14/164


Versican Plus DHPPi/L4


Norway


18.9.2023




EU/2/14/163


Versican Plus DHPPi/L4R


Norway


21.9.2023




EU/2/14/171


Versican Plus L4


Norway


18.9.2023




EU/1/18/1307


Verzenios


Iceland


10.8.2023




EU/1/18/1307


Verzenios


Liechtenstein


30.06.2023




EU/1/18/1307


Verzenios


Norway


13.7.2023




EU/1/18/1298


Veyvondi


Iceland


4.7.2023




EU/1/18/1298


Veyvondi


Liechtenstein


30.6.2023




EU/1/18/1298


Veyvondi


Norway


13.7.2023




EU/1/19/1385


VITRAKVI


Iceland


10.8.2023




EU/1/19/1385


VITRAKVI


Liechtenstein


31.7.2023




EU/1/19/1385


VITRAKVI


Norway


15.8.2023




EU/1/19/1354


Vizimpro


Iceland


18.12.2023




EU/1/19/1354


Vizimpro


Liechtenstein


31.12.2023




EU/1/19/1354


Vizimpro


Norway


12.12.2023




EU/1/18/1308


Vyxeos liposomal


Norway


15.8.2023




EU/1/13/873


Xofigo


Iceland


27.11.2023




EU/1/13/873


Xofigo


Liechtenstein


30.9.2023




EU/1/13/873


Xofigo


Norway


30.11.2023




EU/1/18/1299


Yescarta


Iceland


11.8.2023




EU/1/18/1299


Yescarta


Liechtenstein


31.7.2023




EU/1/18/1299


Yescarta


Norway


15.8.2023




EU/1/18/1327


Ziextenzo


Iceland


10.8.2023




EU/1/18/1327


Ziextenzo


Liechtenstein


30.6.2023




EU/1/18/1327


Ziextenzo


Norway


12.7.2023




EU/1/18/1344


Zirabev


Iceland


29.11.2023




EU/1/18/1344


Zirabev


Liechtenstein


30.11.2023




EU/1/18/1344


Zirabev


Norway


22.11.2023




EU/1/22/1695


Zynlonta


Iceland


29.11.2023




EU/1/22/1695


Zynlonta


Liechtenstein


30.11.2023




EU/1/22/1695


Zynlonta


Norway


12.12.2023









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 2023:








EU-Number


Product


Country


Date of authorisation




EU/1/21/1554/004-005


Adtralza


Iceland


9.10.2023




EU/1/21/1554/004-005


Adtralza


Norway


25.10.2023




EU/1/20/1528/018-024


Comirnaty


Norway


31.8.2023




EU/1/20/1528/015-017


Comirnaty Original/Omicron BA.4-5


Iceland


8.9.2023




EU/1/20/1528/015-017


Comirnaty Original/Omicron BA.4-5


Norway


9.8.2023




EU/1/19/1365/002


Cufence


Iceland


14.12.2023




EU/1/19/1365/002


Cufence


Norway


12.12.2023




EU/1/15/1058/023-024


Entresto


Norway


16.8.2023




EU/1/18/1324/004-006


Erleada


Norway


30.8.2023




EU/1/18/1324/004-006


Erleada


Iceland


5.10.2023




EU/1/19/1374/006-007


Esperoct


Iceland


24.10.2023




EU/1/19/1374/006-007


Esperoct


Norway


10.10.2023




EU/1/18/1323/004


Ilumetri


Iceland


16.8.2023




EU/1/18/1323/004


Ilumetri


Norway


15.8.2023




EU/1/20/1468/003-004


Kaftrio


Iceland


14.12.2023




EU/1/20/1468/003-004


Kaftrio


Norway


12.12.2023




EU/1/12/782/008


Kalydeco


Iceland


13.12.2023




EU/1/12/782/008


Kalydeco


Norway


12.12.2023




EU/1/16/1170/017-019


OLUMIANT


Iceland


23.10.2023




EU/1/15/1059/008


Orkambi


Iceland


9.8.2023




EU/1/15/1059/008


Orkambi


Norway


12.7.2023




EU/1/13/822/006


PHEBURANE


Iceland


28.12.2023




EU/1/12/822/006


Pheburane


Norway


12.12.2023




EU/1/20/1501/005-006


Sogroya


Norway


16.8.2023




EU/1/20/1501/005-006


Sogroya


Iceland


16.8.2023




EU/1/18/1340/007-009


Takhzyro


Iceland


8.12.2023




EU/1/18/1340/007-009


Takhzyro


Norway


12.12.2023




EU/1/15/989/002


Tenkasi


Iceland


23.10.2023




EU/1/15/989/002


Tenkasi


Norway


10.10.2023




EU/1/21/1599/003


Vyepti


Iceland


18.12.2023




EU/1/21/1599/003


Vyepti


Norway


18.12.2023




EU/1/22/1674/002


Vyvgart


Iceland


1.12.2023




EU/1/22/1674/002


Vyvgart


Norway


12.12.2023




EU/1/05/319/012-017


Xolair


Iceland


29.11.2023




EU/1/05/319/012-017,


Xolair


Norway


12.12.2023




EU/1/20/1513/017


Yuflyma


Iceland


8.12.2023




EU/1/20/1513/017


Yuflyma


Norway


12.12.2023









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 2023:








EU-Number


Product


Country


Date of withdrawal




EU/2/10/118


Activyl


Iceland


29.11.2023




EU/2/10/118


Activyl


Liechtenstein


30.11.2023




EU/1/20/1476


Adakveo


Iceland


7.9.2023




EU/1/20/1476


Adakveo


Liechtenstein


31.8.2023




EU/1/20/1476


Adakveo


Norway


21.8.2023




EU/2/13/153


Aftovaxpur Doe


Norway


14.9.2023




EU/1/03/254


Busilvex


Iceland


20.7.2023




EU/2/11/121


CaniLeish


Iceland


25.10.2023




EU/2/11/121


CaniLeish


Liechtenstein


31.10.2023




EU/2/11/121


CaniLeish


Norway


22.11.2023




EU/1/15/1055


Ciambra


Iceland


25.10.2023




EU/1/15/1055


Ciambra


Liechtenstein


31.10.2023




EU/1/15/1055


Ciambra


Norway


28.11.2023




EU/1/09/558


Clopidogrel BGR


Liechtenstein


31.10.2023




EU/1/09/558


Clopidogrel BGR


Iceland


6.11.2023




EU/2/10/115


Comfortis


Iceland


24.8.2023




EU/2/10/115


Comfortis


Norway


21.9.2023




EU/1/21/1624


COVID-19 Vaccine (inactivated, adjuvanted) Valneva


Iceland


25.10.2023




EU/1/21/1624


COVID-19 Vaccine (inactivated, adjuvanted) Valneva


Liechtenstein


31.10.2023




EU/1/21/1624


COVID-19 Vaccine (inactivated, adjuvanted) Valneva


Norway


22.11.2023




EU/1/17/1248


Darunavir Krka d.d.


Norway


23.1.2023 (1)





EU/1/21/1540


Dasatinib Accord


Norway


15.9.2023




EU/1/21/1541


Dasatinib Accordpharma


Norway


15.9.2023




EU/1/21/1568


Imatinib Koanaa


Iceland


11.9.2023




EU/1/21/1568


Imatinib Koanaa


Liechtenstein


31.8.2023




EU/1/21/1568


Imatinib Koanaa


Norway


21.9.2023




EU/1/22/1644


Inpremzia


Norway


14.9.2023




EU/1/96/026


Invirase


Iceland


31.8.2023




EU/1/96/026


Invirase


Liechtenstein


31.8.2023




EU/1/96/026


Invirase


Norway


21.9.2023




EU/1/19/1396


Ivozall


Iceland


2.11.2023




EU/1/19/1396


Ivozall


Liechtenstein


31.10.2023




EU/1/19/1396


Ivozall


Norway


1.11.2023




EU/1/13/819


JETREA


Iceland


11.9.2023




EU/1/13/819


JETREA


Liechtenstein


31.8.2023




EU/1/13/819


JETREA


Norway


11.10.2023




EU/1/10/663


Lamivudine/Zidovudine Teva


Norway


21.9.2023




EU/1/20/1521


Lenalidomide Krka d.d.


Norway


21.9.2023




EU/1/20/1519


Lenalidomide Krka d.d. Novo mesto


Liechtenstein


30.9.2023




EU/1/09/598


Nevirapine Teva


Norway


1.11.2023




EU/1/17/1217


Nitisinone MDK


Norway


26.10.2023




EU/2/11/132


Nobivac Myxo-RHD


Iceland


8.9.2023




EU/2/11/132


Nobivac Myxo-RHD


Liechtenstein


31.8.2023




EU/2/11/132


Nobivac Myxo-RHD


Norway


24.8.2023




EU/1/20/1499


Onbevzi


Iceland


19.12.2023




EU/1/20/1499


Onbevzi


Liechtenstein


31.12.2023




EU/1/09/571


Pandemic influenza vaccine H5N1 BAXTER


Liechtenstein


30.9.2023




EU/1/09/571


Pandemic Influenza Vaccine H5N1 BAXTER


Norway


22.11.2023




EU/1/09/571


Pandemic Influenza Vaccine H5N1 BAXTER


Iceland


25.10.2023




EU/1/12/757


Pioglitazone Teva


Norway


21.9.2023




EU/1/15/1012


Pregabalin Sandoz GmbH


Iceland


24.10.2023




EU/1/15/1012


Pregabalin Sandoz GmbH


Liechtenstein


31.10.2023




EU/1/15/1012


Pregabalin Sandoz GmbH


Norway


29.11.2023




EU/1/16/1166


Pregabalin Zentiva k.s.,


Norway


14.9.2023




EU/1/99/107


Rebetol


Iceland


26.10.2023




EU/1/99/107


Rebetol


Liechtenstein


31.10.2023




EU/1/99/107


Rebetol


Norway


2.11.2023




EU/1/22/1712


Tremelimumab AstraZeneca


Iceland


29.11.2023




EU/1/22/1712


Tremelimumab AstraZeneca


Liechtenstein


30.11.2023




EU/1/22/1712


Tremelimumab AstraZeneca


Norway


28.11.2023




EU/1/20/1478


Zynrelef


Liechtenstein


31.10.2023




EU/1/20/1478


Zynrelef


Norway


28.11.2023




EU/1/20/1478


Zynrelef


Iceland


25.10.2023






(1)  Withdrawal was unintentionally omitted from the list for the 1st half of 2023.





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 2023:








EU-Number


Product


Country


Date of suspension




 


 


 


 




 


 


 


 




 


 


 


 







ELI: http://data.europa.eu/eli/C/2024/4358/oj
ISSN 1977-091X (electronic edition)