Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2023 – Subcommittee I on the free movement of goods
Date: 2024-01-25
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_202401116EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/1116


25.1.2024






Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2023
(C/2024/1116)
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 January – 30 June 2023, at their meeting on 22 September 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Annex IV List of withdrawn marketing authorisations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 January – 30 June 2023:








EU-Number


Product


Country


Date of authorisation




EU/1/22/1625


Paxlovid


Norway


31.5.2023




EU/1/22/1625


Paxlovid


Liechtenstein


28.2.2023




EU/1/22/1665


Dabigatran Etexilate Accord


Norway


13.6.2023




EU/1/22/1665


Dabigatran Etexilate Accord


Iceland


9.6.2023




EU/1/22/1665


Dabigatran Etexilate Accord


Liechtenstein


31.5.2023




EU/1/22/1684


Nulibry


Iceland


12.1.2023




EU/1/22/1688


Spevigo


Iceland


3.1.2023




EU/1/22/1692


Locametz


Iceland


3.1.2023




EU/1/22/1692


Locametz


Norway


3.1.2023




EU/1/22/1695


Zynlonta


Iceland


10.1.2023




EU/1/22/1695


Zynlonta


Norway


10.1.2023




EU/1/22/1700


Ebvallo


Iceland


10.1.2023




EU/1/22/1701


Plerixafor Accord


Iceland


10.1.2023




EU/1/22/1702


Dimethyl fumarate Teva


Iceland


9.1.2023




EU/1/22/1702


Dimethyl fumarate Teva


Norway


10.1.2023




EU/1/22/1703


Pluvicto


Iceland


3.1.2023




EU/1/22/1704


Livmarli


Iceland


3.1.2023




EU/1/22/1706


Eladynos


Iceland


10.1.2023




EU/1/22/1707


Pirfenidone Viatris


Norway


25.1.2023




EU/1/22/1707


Pirfenidone Viatris


Iceland


27.1.2023




EU/1/22/1707


Pirfenidone Viatris


Liechtenstein


31.1.2023




EU/1/22/1708


Sugammadex Amomed


Norway


10.1.2023




EU/1/22/1708


Sugammadex Amomed


Iceland


26.1.2023




EU/1/22/1708


Sugammadex Amomed


Liechtenstein


31.1.2023




EU/1/22/1709


Bimervax


Norway


31.3.2023




EU/1/22/1709


Bimervax


Iceland


25.5.2023




EU/1/22/1709


Bimervax


Liechtenstein


31.3.2023




EU/1/22/1710


Kauliv


Iceland


13.2.2023




EU/1/22/1710


Kauliv


Liechtenstein


31.1.2023




EU/1/22/1710


Kauliv


Norway


16.1.2023




EU/1/22/1711


Dimethyl fumarate Accord


Iceland


2.5.2023




EU/1/22/1711


Dimethyl fumarate Accord


Liechtenstein


28.2.2023




EU/1/22/1711


Dimethyl fumarate Accord


Norway


3.3.2023




EU/1/22/1712


Tremelimumab AstraZeneca


Iceland


22.3.2023




EU/1/22/1712


Tremelimumab AstraZeneca


Liechtenstein


28.2.2023




EU/1/22/1712


Tremelimumab AstraZeneca


Norway


13.3.2023




EU/1/22/1713


Imjudo


Iceland


23.3.2023




EU/1/22/1713


Imjudo


Liechtenstein


28.2.2023




EU/1/22/1713


Imjudo


Norway


13.3.2023




EU/1/22/1714


Pombiliti


Iceland


21.4.2023




EU/1/22/1714


Pombiliti


Liechtenstein


31.3.2023




EU/1/22/1714


Pombiliti


Norway


31.3.2023




EU/1/22/1715


Hemgenix


Iceland


22.3.2023




EU/1/22/1715


Hemgenix


Liechtenstein


28.2.2023




EU/1/22/1715


Hemgenix


Norway


10.3.2023




EU/1/23/1716


CAMZYOS


Liechtenstein


30.6.2023




EU/1/23/1718


Sotyktu


Iceland


21.4.2023




EU/1/23/1718


Sotyktu


Norway


11.4.2023




EU/1/23/1718


Sotyktu


Liechtenstein


31.3.2023




EU/1/23/1719


Tolvaptan Accord


Iceland


21.4.2023




EU/1/23/1719


Tolvaptan Accord


Norway


11.4.2023




EU/1/23/1719


Tolvaptan Accord


Liechtenstein


31.3.2023




EU/1/23/1720


Sitagliptin/Metformin hydrochloride SUN


Iceland


28.4.2023




EU/1/23/1720


Sitagliptin/Metformin hydrochloride SUN


Liechtenstein


31.3.2023




EU/1/23/1720


Sitagliptin/Metformin hydrochloride SUN


Norway


2.5.2023




EU/1/23/1721


Dapagliflozin Viatris


Liechtenstein


31.3.2023




EU/1/23/1721


Dapagliflozin Viatris


Norway


11.4.2023




EU/1/23/1721


Dapagliflozin Viatris


Iceland


21.4.2023




EU/1/23/1722


Akeega


Iceland


26.5.2023




EU/1/23/1722


Akeega


Liechtenstein


30.4.2023




EU/1/23/1723


Hyftor


Iceland


30.5.2023




EU/1/23/1723


Hyftor


Liechtenstein


31.5.2023




EU/1/23/1723


Hyftor


Norway


5.6.2023




EU/1/23/1724


Elfabrio


Iceland


24.5.2023




EU/1/23/1724


Elfabrio


Liechtenstein


31.5.2023




EU/1/23/1724


Elfabrio


Norway


23.5.2023




EU/1/23/1725


Vafseo


Iceland


23.5.2023




EU/1/23/1725


Vafseo


Liechtenstein


30.4.2023




EU/1/23/1726


Opzelura


Iceland


19.5.2023




EU/1/23/1726


Opzelura


Liechtenstein


30.4.2023




EU/1/23/1726


Opzelura


Norway


5.5.2023




EU/1/23/1727


Bekemv


Iceland


26.5.2023




EU/1/23/1727


Bekemv


Liechtenstein


30.4.2023




EU/1/23/1727


Bekemv


Norway


13.6.2023




EU/1/23/1728


Tibsovo


Iceland


30.5.2023




EU/1/23/1728


Tibsovo


Liechtenstein


31.5.2023




EU/1/23/1728


Tibsovo


Norway


23.5.2023




EU/1/23/1730


Briumvi


Iceland


13.6.2023




EU/1/23/1730


Briumvi


Liechtenstein


31.5.2023




EU/1/23/1730


Briumvi


Norway


30.6.2023




EU/1/23/1731


Qaialdo


Iceland


9.6.2023




EU/1/23/1731


Qaialdo


Liechtenstein


31.5.2023




EU/1/23/1731


Qaialdo


Norway


12.6.2023




EU/1/23/1732


Lacosamide Adroiq


Iceland


13.6.2023




EU/1/23/1732


Lacosamide Adroiq


Liechtenstein


31.5.2023




EU/1/23/1732


Lacosamide Adroiq


Norway


12.6.2023




EU/1/23/1733


Sugammadex Adroiq


Iceland


6.6.2023




EU/1/23/1733


Sugammadex Adroiq


Liechtenstein


31.5.2023




EU/1/23/1733


Sugammadex Adroiq


Norway


12.6.2023




EU/1/23/1734


Pedmarqsi


Iceland


9.6.2023




EU/1/23/1734


Pedmarqsi


Liechtenstein


31.5.2023




EU/1/23/1734


Pedmarqsi


Norway


30.6.2023




EU/1/23/1735


Epysqli


Iceland


5.6.2023




EU/1/23/1735


Epysqli


Liechtenstein


31.5.2023




EU/1/23/1735


Epysqli


Norway


9.6.2023




EU/1/23/1736


Omvoh


Iceland


12.6.2023




EU/1/23/1736


Omvoh


Liechtenstein


31.5.2023




EU/1/23/1736


Omvoh


Norway


12.6.2023




EU/1/23/1737


Opfolda


Liechtenstein


30.6.2023




EU/1/23/1739


Sugammadex Piramal


Liechtenstein


30.6.2023




EU/1/23/1740


Arexvy


Iceland


14.6.2023




EU/1/23/1740


Arexvy


Liechtenstein


30.6.2023




EU/1/23/1740


Arexvy


Norway


12.6.2023




EU/1/123/1725


Vafseo


Norway


23.5.2023




EU/2/22/285


DogStem


Iceland


3.1.2023




EU/2/22/285


DogStem


Liechtenstein


31.12.2022 (1)





EU/2/22/285


DogStem


Norway


24.4.2023




EU/2/22/289


Mometamax Ultra


Iceland


10.1.2023




EU/2/22/289


Mometamax Ultra


Liechtenstein


31.12.2022 (2)





EU/2/22/289


Mometamax Ultra


Norway


24.4.2023




EU/2/22/290


Neoleish


Iceland


23.1.2023




EU/2/22/290


Neoleish


Liechtenstein


31.12.2022 (3)





EU/2/22/290


Neoleish


Norway


26.1.2023




EU/2/22/291


Brucellin Aquilon


Iceland


10.2.2023




EU/2/22/291


Brucellin Aquilon


Liechtenstein


31.1.2023




EU/2/22/291


Brucellin Aquilon


Norway


6.2.2023




EU/2/23/292


Innovax-ILT-IBD


Iceland


2.5.2023




EU/2/23/292


Innovax-ILT-IBD


Liechtenstein


30.4.2023




EU/2/23/292


Innovax-ILT-IBD


Norway


3.5.2023




EU/2/23/293


Eurican L4


Iceland


22.6.2023




EU/2/23/293


Eurican L4


Liechtenstein


31.3.2023




EU/2/23/293


Eurican L4


Norway


13.4.2023




EU/2/23/294


Bovilis Nasalgen-C


Iceland


27.4.2023




EU/2/23/294


Bovilis Nasalgen-C


Liechtenstein


31.3.2023




EU/2/23/294


Bovilis Nasalgen-C


Norway


13.4.2023




EU/2/23/295


Prolevare


Liechtenstein


30.4.2023




EU/2/23/295


Prolevare


Norway


8.5.2023




EU/2/23/295


Prolevare


Iceland


19.5.2023




EU/2/23/296


Newflend ND H9


Iceland


24.5.2023




EU/2/23/296


Newflend ND H9


Liechtenstein


30.5.2023




EU/2/23/296


Newflend ND H9


Norway


7.6.2023




EU/2/23/297


Eluracat


Liechtenstein


30.6.2023






(1)  Authorisation was unintentionally omitted from the list for the 2nd half of 2022.

(2)  Authorisation was unintentionally omitted from the list for the 2nd half of 2022.

(3)  Authorisation was unintentionally omitted from the list for the 2nd half of 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 2023:








EU-Number


Product


Country


Date of authorisation




EU/1/13/850


Imnovid


Iceland


23.5.2023




EU/1/13/850


Imnovid


Liechtenstein


30.4.2023




EU/1/13/850


Imnovid


Norway


24.4.2023




EU/1/13/851


Lojuxta


Iceland


1.6.2023




EU/1/13/851


Lojuxta


Liechtenstein


31.5.2023




EU/1/13/851


Lojuxta


Norway


16.6.2023




EU/1/13/856


Lonquex


Iceland


19.5.2023




EU/1/13/856


Lonquex


Liechtenstein


30.4.2023




EU/1/13/856


Lonquex


Norway


15.5.2023




EU/1/13/875


Deltyba


Iceland


24.4.2023




EU/1/13/875


Deltyba


Liechtenstein


31.3.2023




EU/1/13/875


Deltyba


Norway


17.4.2023




EU/1/13/878


Defitelio


Iceland


12.6.2023




EU/1/13/878


Defitelio


Liechtenstein


31.5.2023




EU/1/13/901


Sirturo


Iceland


9.1.2023




EU/1/13/901


Sirturo


Norway


9.1.2023




EU/1/14/987


Holoclar


Iceland


27.1.2023




EU/1/14/987


Holoclar


Liechtenstein


31.1.2023




EU/1/14/987


Holoclar


Norway


23.1.2023




EU/1/15/1047


Blincyto


Iceland


24.3.2023




EU/1/15/1047


Blincyto


Liechtenstein


31.3.2023




EU/1/15/1047


Blincyto


Norway


31.3.2023




EU/1/15/1078


Natpar


Iceland


22.3.2023




EU/1/15/1078


Natpar


Liechtenstein


31.3.2023




EU/1/16/1089


Pandemic Influenza Vaccine H5N1 AstraZeneca


Norway


19.4.2023




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Iceland


22.3.2023




EU/1/16/1089


Pandemic influenza vaccine H5N1 AstraZeneca


Liechtenstein


31.3.2023




EU/1/16/1139


Ocaliva


Liechtenstein


30.11.2022 (1)





EU/1/16/1139


Ocaliva


Norway


2.1.2023




EU/1/17/1173


Lokelma


Iceland


17.2.2023




EU/1/17/1173


Lokelma


Liechtenstein


28.2.2023




EU/1/17/1173


Lokelma


Norway


13.3.2023




EU/1/17/1219


Verkazia


Iceland


24.4.2023




EU/1/17/1219


Verkazia


Liechtenstein


31.3.2023




EU/1/17/1219


Verkazia


Norway


13.4.2023




EU/1/17/1236


Trelegy Ellipta


Norway


28.2.2023




EU/1/17/1245


Prevymis


Iceland


21.2.2023




EU/1/17/1247


Adynovi


Iceland


13.1.2023




EU/1/17/1249


Darunavir Krka


Iceland


13.1.2023




EU/1/17/1253


Fulvestrant Mylan


Norway


23.1.2023




EU/1/17/1253


Fulvestrant Mylan


Iceland


30.1.2023




EU/1/17/1253


Fulvestrant Mylan


Liechtenstein


31.1.2023




EU/1/17/1257


Herzuma


Iceland


9.1.2023




EU/1/17/1258


Lamzede


Iceland


27.1.2023




EU/1/17/1258


Lamzede


Liechtenstein


31.1.2023




EU/1/17/1258


Lamzede


Norway


25.1.2023




EU/1/17/1261


Alofisel


Iceland


25.1.2023




EU/1/17/1261


Alofisel


Liechtenstein


31.1.2023




EU/1/17/1261


Alofisel


Norway


25.1.2023




EU/1/18/1270


Semglee


Iceland


22.3.2023




EU/1/18/1270


Semglee


Liechtenstein


28.2.2023




EU/1/18/1270


Semglee


Norway


13.3.2023




EU/1/18/1273


Prasugrel Mylan


Iceland


24.3.2023




EU/1/18/1273


Prasugrel Mylan


Liechtenstein


31.3.2023




EU/1/18/1274


Trydonis


Iceland


9.1.2023




EU/1/18/1274


Trydonis


Norway


10.1.2023




EU/1/18/1275


Riarify


Iceland


9.1.2023




EU/1/18/1276


Myalepta


Iceland


24.4.2023




EU/1/18/1276


Myalepta


Liechtenstein


31.3.2023




EU/1/18/1276


Myalepta


Norway


2.5.2023




EU/1/18/1278


Carmustine Obvius


Iceland


23.5.2023




EU/1/18/1278


Carmustine Obvius


Liechtenstein


31.5.2023




EU/1/18/1278


Carmustine Obvius


Norway


30.5.2023




EU/1/18/1279


Amglidia


Iceland


17.2.2023




EU/1/18/1279


Amglidia


Liechtenstein


28.2.2023




EU/1/18/1279


Amglidia


Norway


10.3.2023




EU/1/18/1281


Kanjinti


Iceland


10.2.2023




EU/1/18/1281


Kanjinti


Liechtenstein


28.2.2023




EU/1/18/1281


Kanjinti


Norway


7.3.2023




EU/1/18/1282


Juluca


Iceland


30.1.2023




EU/1/18/1282


Juluca


Liechtenstein


31.1.2023




EU/1/18/1282


Juluca


Norway


6.2.2023




EU/1/18/1283


Pemetrexed Krka


Iceland


22.3.2023




EU/1/18/1283


Pemetrexed Krka


Liechtenstein


28.2.2023




EU/1/18/1283


Pemetrexed Krka


Norway


10.3.2023




EU/1/18/1284


Dzuveo


Iceland


24.4.2023




EU/1/18/1284


Dzuveo


Liechtenstein


31.3.2023




EU/1/18/1284


Dzuveo


Norway


11.4.2023




EU/1/18/1286


Hyrimoz


Iceland


17.3.2023




EU/1/18/1286


Hyrimoz


Liechtenstein


28.2.2023




EU/1/18/1286


Hyrimoz


Norway


10.3.2023




EU/1/18/1287


Hefiya


Iceland


13.2.2023




EU/1/18/1287


Hefiya


Liechtenstein


28.2.2023




EU/1/18/1287


Hefiya


Norway


07.3.2023




EU/1/18/1289


Biktarvy


Iceland


16.1.2023




EU/1/18/1289


Biktarvy


Liechtenstein


31.1.2023




EU/1/18/1289


Biktarvy


Norway


23.1.2023




EU/1/18/1290


Nityr


Iceland


23.5.2023




EU/1/18/1290


Nityr


Liechtenstein


31.5.2023




EU/1/18/1290


Nityr


Norway


4.5.2023




EU/1/18/1293


Aimovig


Iceland


22.3.2023




EU/1/18/1293


Aimovig


Liechtenstein


28.2.2023




EU/1/18/1293


Aimovig


Norway


13.3.2023




EU/1/18/1294


Rxulti


Iceland


12.6.2023




EU/1/18/1294


Rxulti


Liechtenstein


31.5.2023




EU/1/18/1295


Trazimera


Iceland


29.3.2023




EU/1/18/1295


Trazimera


Liechtenstein


31.3.2023




EU/1/18/1295


Trazimera


Norway


4.4.2023




EU/1/18/1296


Tegsedi


Iceland


24.4.2023




EU/1/18/1296


Tegsedi


Liechtenstein


30.4.2023




EU/1/18/1296


Tegsedi


Norway


24.4.2023




EU/1/18/1297


Kymriah


Iceland


23.5.2023




EU/1/18/1297


Kymriah


Liechtenstein


30.4.2023




EU/1/18/1297


Kymriah


Norway


26.4.2023




EU/1/18/1298


VEYVONDI


Liechtenstein


30.6.2023




EU/1/18/1305


Cablivi


Iceland


25.4.2023




EU/1/18/1305


Cablivi


Liechtenstein


30.4.2023




EU/1/18/1305


Cablivi


Norway


15.5.2023




EU/1/18/1308


Vyxeos liposomal


Iceland


13.6.2023




EU/1/18/1308


Vyxeos liposomal


Liechtenstein


30.6.2023




EU/1/18/1310


Deferiprone Lipomed


Liechtenstein


30.6.2023




EU/1/18/1311


Nerlynx


Iceland


12.6.2023




EU/1/18/1311


Nerlynx


Liechtenstein


31.5.2023




EU/1/18/1311


Nerlynx


Norway


30.6.2023




EU/1/18/1312


Xerava


Iceland


25.4.2023




EU/1/18/1312


Xerava


Liechtenstein


30.4.2023




EU/1/18/1312


Xerava


Norway


20.4.2023




EU/1/18/1313


Pelgraz


Iceland


30.6.2023




EU/1/18/1313


Pelgraz


Liechtenstein


30.6.2023




EU/1/18/1315


Mektovi


Liechtenstein


30.6.2023




EU/1/18/1318


Slenyto


Iceland


14.6.2023




EU/1/18/1318


Slenyto


Liechtenstein


30.6.2023




EU/1/18/1320


Onpattro


Iceland


25.4.2023




EU/1/18/1320


Onpattro


Liechtenstein


30.4.2023




EU/1/18/1320


Onpattro


Norway


2.5.2023




EU/1/18/1322


Imfinzi


Iceland


30.5.2023




EU/1/18/1322


Imfinzi


Liechtenstein


30.4.2023




EU/1/18/1324


Jivi


Liechtenstein


30.6.2023




EU/1/18/1345


Ondexxya


Iceland


23.5.2023




EU/1/18/1345


Ondexxya


Liechtenstein


30.4.2023




EU/1/18/1345


Ondexxya


Norway


8.6.2023




EU/1/18/1273


Prasugrel Mylan


Norway


4.4.2023




EU/1/19/1355


Lorviqua


Iceland


25.4.2023




EU/1/19/1355


Lorviqua


Liechtenstein


30.4.2023




EU/1/19/1355


Lorviqua


Norway


2.5.2023




EU/1/19/1360


Waylivra


Iceland


23.5.2023




EU/1/19/1360


Waylivra


Liechtenstein


31.5.2023




EU/1/19/1360


Waylivra


Norway


8.6.2023




EU/1/20/1476


Adakveo


Iceland


21.2.2023




EU/1/20/1492


Tecartus


Norway


28.2.2023




EU/1/20/1508


Enhertu


Iceland


13.1.2023




EU/1/20/1525


Jcovden


Iceland


16.1.2023




EU/1/20/1525


Jcovden


Liechtenstein


31.1.2023




EU/1/20/1525


Jcovden


Norway


1.2.2023




EU/1/20/1527


Retsevmo


Iceland


4.1.2023




EU/1/20/1527


Retsevmo


Norway


26.1.2023




EU/1/21/1529


Vaxzevria


Iceland


28.2.2023




EU/1/21/1535


Pemazyre


Iceland


22.3.2023




EU/1/21/1535


Pemazyre


Liechtenstein


28.2.2023




EU/1/21/1535


Pemazyre


Norway


22.3.2023




EU/1/21/1538


Jemperli


Iceland


17.3.2023




EU/1/21/1538


Jemperli


Liechtenstein


28.2.2023




EU/1/21/1538


Jemperli


Norway


14.3.2023




EU/1/21/1539


Abecma


Iceland


14.6.2023




EU/1/21/1539


Abecma


Liechtenstein


30.6.2023




EU/1/21/1552


Koselugo


Iceland


14.6.2023




EU/1/21/1552


Koselugo


Liechtenstein


31.5.2023




EU/1/21/1603


Lumykras


Iceland


13.1.2023




EU/1/21/1603


Lumykras


Norway


1.3.2023




EU/1/21/1618


Nuvaxovid


Iceland


12.1.2023




EU/1/22/1648


Carvykti


Iceland


24.4.2023




EU/1/22/1648


Carvykti


Liechtenstein


31.3.2023




EU/1/22/1648


Carvykti


Norway


12.4.2023




EU/1/22/1649


Lunsumio


Iceland


25.4.2023




EU/1/22/1649


Lunsumio


Liechtenstein


30.4.2023




EU/1/22/1649


Lunsumio


Norway


16.5.2023




EU/2/13/151


Equilis West Nile


Liechtenstein


31.5.2023




EU/2/13/151


Equilis West Nile


Norway


28.6.2023




EU/2/17/216


Oxybee


Liechtenstein


31.1.2023




EU/2/17/216


Oxybee


Norway


14.3.2023




EU/2/17/217


Nobivac LeuFel


Liechtenstein


31.10.2022 (2)





EU/2/17/217


Nobivac LeuFel


Norway


25.4.2023




EU/2/17/219


Rabitec


Liechtenstein


31.10.2022 (3)





EU/2/17/219


Rabitec


Norway


24.4.2023




EU/2/17/220


MiPet Easecto


Liechtenstein


28.2.2023




EU/2/17/221


Galliprant


Liechtenstein


31.1.2023




EU/2/17/221


Galliprant


Norway


25.4.2023




EU/2/17/222


Clevor


Liechtenstein


31.3.2023




EU/2/18/225


Dany’s BienenWohl


Liechtenstein


30.5.2023




EU/2/18/227


UBAC


Liechtenstein


30.5.2023




EU/2/19/243


Simparica Trio


Norway


25.4.2023






(1)  Authorisation was unintentionally omitted from the list for the 2nd half of 2022.

(2)  Authorisation was unintentionally omitted from the list for the 2nd half of 2022.

(3)  Authorisation was unintentionally omitted from the list for the 2nd 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 January – 30 June 2023:








EU-Number


Product


Country


Date of authorisation




EU/1/08/476/007


Adcirca


Iceland


23.3.2023




EU/1/08/476/007


Adcirca


Norway


14.3.2023




EU/1/14/940/003


Triumeq


Iceland


19.4.2023




EU/1/14/940/003


Triumeq


Norway


27.4.2023




EU/1/15/1058/023-024


Entresto


Iceland


12.6.2023




EU/1/16/1103/018-019


Neparvis


Iceland


13.6.2023




EU/1/16/1103/018-019


Neparvis


Norway


30.6.2023




EU/1/17/1193/004


Refixia


Iceland


9.1.2023




EU/1/17/1193/004


Refixia


Norway


16.2.2023




EU/1/18/1286/008-011


Hyrimoz


Iceland


25.5.2023




EU/1/18/1287/008-011


Hefiya


Iceland


31.5.2023




EU/1/19/1361/004-005


Skyrizi


Iceland


14.2.2023




EU/1/19/1371/004


ULTOMIRIS


Iceland


14.6.2023




EU/1/20/1479/003-004


Calquence


Iceland


23.3.2023




EU/1/20/1479/003-004


Calquence


Norway


14.3.2023




EU/1/20/1500/005


Xofluza


Iceland


27.1.2023




EU/1/20/1500/005


Xofluza


Norway


25.1.2023




EU/1/20/1505/002


Byfavo


Iceland


28.4.2023




EU/1/20/1505/002


Byfavo


Norway


25.4.2023









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 2023:








EU-Number


Product


Country


Date of withdrawal




EU/1/00/166


NeuroBloc


Iceland


13.1.2023




EU/1/00/166


NeuroBloc


Norway


13.3.2023




EU/1/03/254


Busilvex


Liechtenstein


31.1.2023




EU/1/03/254


Busilvex


Norway


25.1.2023




EU/1/09/598


Nevirapine Teva


Iceland


24.3.2023




EU/1/09/598


Nevirapine Teva


Liechtenstein


31.3.2023




EU/1/10/616


Temozolomide Hexal


Iceland


13.1.2023




EU/1/10/616


Temozolomide Hexal


Norway


8.2.2023




EU/1/10/617


Temozolomide Sandoz


Iceland


13.1.2023




EU/1/10/663


Lamivudine / Zidovudine Teva


Liechtenstein


31.3.2023




EU/1/10/663


Lamivudine / Zidovudine Teva


Iceland


24.3.2023




EU/1/12/756


Glidipion


Norway


13.3.2023




EU/1/12/757


Pioglitazone Teva


Iceland


25.4.2023




EU/1/12/757


Pioglitazone Teva


Liechtenstein


31.3.2023




EU/1/16/1166


Pregabalin Zentiva k.s


Liechtenstein


28.2.2023




EU/1/16/1166


Pregabalin Zentiva k.s.


Iceland


24.3.2023




EU/1/17/1217


Nitisinone MDK


Iceland


25.4.2023




EU/1/17/1217


Nitisinone MDK


Liechtenstein


31.3.2023




EU/1/17/1248


Darunavir Krka d.d.


Iceland


13.2.2023




EU/1/17/1248


Darunavir Krka d.d.


Liechtenstein


31.1.2023




EU/1/19/1359


Trogarzo


Iceland


17.3.2023




EU/1/19/1359


Trogarzo


Norway


13.3.2023




EU/1/19/1378


Temybric Ellipta


Iceland


13.2.2023




EU/1/20/1521


Lenalidomide Krka d.d.


Iceland


21.6.2023




EU/1/20/1521


Lenalidomide Krka d.d.


Liechtenstein


30.6.2023




EU/1/21/1540


Dasatinib Accord


Iceland


25.4.2023




EU/1/21/1540


Dasatinib Accord


Liechtenstein


31.3.2023




EU/1/21/1541


Dasatinib Accordpharma


Iceland


25.4.2023




EU/1/21/1541


Dasatinib Accordpharma


Liechtenstein


31.3.2023




EU/1/22/1644


Inpremzia


Iceland


25.4.2023




EU/1/22/1644


Inpremzia


Liechtenstein


30.4.2023




EU/2/02/036


Nobilis OR inac


Iceland


9.2.2023




EU/2/10/106


Bovilis BTV8


Iceland


9.2.2023




EU/2/10/115


Comfortis


Liechtenstein


30.5.2023




EU/2/11/137


Activyl Tick Plus


Iceland


9.2.2023




EU/2/13/153


Aftovaxpur Doe


Iceland


1.6.2023




EU/2/13/153


Aftovaxpur Doe


Liechtenstein


30.5.2023









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 2023:









EU-Number




Product




Country




Date of suspension





 


 


 


 




 


 


 


 




 


 


 


 




 


 


 


 




 


 


 


 




 


 


 


 







ELI: http://data.europa.eu/eli/C/2024/1116/oj
ISSN 1977-091X (electronic edition)