Official Journal
of the European Union
EN
C series
|
|
Official Journal |
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List of withdrawn marketing authorisations |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)