This document is an excerpt from the EUR-Lex website
Document E2024G04358
Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2023
Lægemidler — Liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne for anden halvdel af 2023
Lægemidler — Liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne for anden halvdel af 2023
EUT C, C/2024/4358, 4.7.2024, ELI: http://data.europa.eu/eli/C/2024/4358/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
Den Europæiske Unions |
DA C-udgaven |
|
C/2024/4358 |
4.7.2024 |
Lægemidler — Liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne for anden halvdel af 2023
(C/2024/4358)
Underudvalg I for frie varebevægelser
Til Det Blandede EØS-Udvalgs underretning
Under henvisning til Det Blandede EØS-Udvalgs beslutning nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-Udvalg til på sit møde den 15. marts 2024 at notere sig følgende lister over markedsføringstilladelser for lægemidler udstedt i perioden 1. juli – 31. december 2023 :
|
Bilag I |
Liste over nye markedsføringstilladelser |
|
Bilag II |
Liste over fornyede markedsføringstilladelser |
|
Bilag III |
Liste over udvidede markedsføringstilladelser |
|
Bilag IV |
Liste over tilbagetrukne markedsføringstilladelser |
|
Bilag V |
Liste over suspenderede markedsføringstilladelser |
BILAG I
Liste over nye markedsføringstilladelser
Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne for perioden 1. juli – 31. december 2023:
|
EU-nummer |
Produkt |
Land |
Udstedelsesdato |
|
EU/1/23/1752 |
Abrysvo |
Island |
6.9.2023 |
|
EU/1/23/1752 |
Abrysvo |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1752 |
Abrysvo |
Norge |
9.10.2023 |
|
EU/1/23/1776 |
AGAMREE |
Island |
28.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Norge |
19.12.2023 |
|
EU/1/23/1722 |
AKEEGA |
Norge |
25.7.2023 |
|
EU/1/23/1760 |
Apretude |
Island |
16.10.2023 |
|
EU/1/23/1760 |
Apretude |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1760 |
Apretude |
Norge |
9.10.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Island |
30.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Norge |
29.8.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Island |
4.12.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Norge |
20.11.2023 |
|
EU/2/23/303 |
Bovilis Cryptium |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1716 |
Camzyos |
Island |
9.8.2023 |
|
EU/1/23/1716 |
Camzyos |
Norge |
12.7.2023 |
|
EU/1/23/1763 |
Catiolanze |
Island |
4.12.2023 |
|
EU/1/23/1763 |
Catiolanze |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1763 |
Catiolanze |
Norge |
12.12.2023 |
|
EU/1/23/1742 |
Columvi |
Island |
9.8.2023 |
|
EU/1/23/1742 |
Columvi |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1742 |
Columvi |
Norge |
13.7.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Island |
23.10.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Norge |
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 |
Island |
4.12.2023 |
|
EU/1/23/1765 |
Ebglyss |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1765 |
Ebglyss |
Norge |
30.11.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Island |
18.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Norge |
13.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Island |
18.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Norge |
18.12.2023 |
|
EU/2/23/297 |
Eluracat |
Island |
9.8.2023 |
|
EU/2/23/297 |
Eluracat |
Norge |
23.8.2023 |
|
EU/1/23/1747 |
Enrylaze |
Island |
19.10.2023 |
|
EU/1/23/1747 |
Enrylaze |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1747 |
Enrylaze |
Norge |
10.10.2023 |
|
EU/1/23/1767 |
Finlee |
Island |
4.12.2023 |
|
EU/1/23/1767 |
Finlee |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1767 |
Finlee |
Norge |
12.12.2023 |
|
EU/1/23/1762 |
Herwenda |
Island |
4.12.2023 |
|
EU/1/23/1762 |
Herwenda |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1762 |
Herwenda |
Norge |
12.12.2023 |
|
EU/1/23/1756 |
Inaqovi |
Island |
13.10.2023 |
|
EU/1/23/1756 |
Inaqovi |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1756 |
Inaqovi |
Norge |
28.9.2023 |
|
EU/1/23/1738 |
Jaypirca |
Island |
28.11.2023 |
|
EU/1/23/1738 |
Jaypirca |
Liechtenstein |
31.10.2023 |
|
EU/1/23/1738 |
Jaypirca |
Norge |
8.11.2023 |
|
EU/1/23/1755 |
Litfulo |
Island |
13.10.2023 |
|
EU/1/23/1755 |
Litfulo |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1755 |
Litfulo |
Norge |
9.10.2023 |
|
EU/1/23/1774 |
Loargys |
Island |
28.12.2023 |
|
EU/1/23/1774 |
Loargys |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1774 |
Loargys |
Norge |
19.12.2023 |
|
EU/2/23/301 |
Loxitab |
Island |
26.10.2023 |
|
EU/2/23/301 |
Loxitab |
Liechtenstein |
31.10.2023 |
|
EU/2/23/301 |
Loxitab |
Norge |
1.11.2023 |
|
EU/1/21/1613 |
Lyfnua |
Island |
19.10.2023 |
|
EU/1/21/1613 |
Lyfnua |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1613 |
Lyfnua |
Norge |
10.10.2023 |
|
EU/1/23/1741 |
Lytgobi |
Island |
9.8.2023 |
|
EU/1/23/1741 |
Lytgobi |
Norge |
11.7.2023 |
|
EU/1/23/1741 |
Lytgobi |
Liechtenstein |
31.7.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
Island |
11.12.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1737 |
Opfolda |
Island |
9.8.2023 |
|
EU/1/23/1737 |
Opfolda |
Norge |
12.7.2023 |
|
EU/1/23/1757 |
ORSERDU |
Island |
19.10.2023 |
|
EU/1/23/1757 |
ORSERDU |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1757 |
ORSERDU |
Norge |
10.10.2023 |
|
EU/2/23/299 |
Oxmax |
Island |
26.10.2023 |
|
EU/2/23/299 |
Oxmax |
Liechtenstein |
31.10.2023 |
|
EU/2/23/299 |
Oxmax |
Norge |
26.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Island |
27.11.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Liechtenstein |
31.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Norge |
26.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Island |
27.11.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Liechtenstein |
31.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Norge |
24.10.2023 |
|
EU/1/23/1746 |
Pylclari |
Island |
16.8.2023 |
|
EU/1/23/1746 |
Pylclari |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1746 |
Pylclari |
Norge |
15.8.2023 |
|
EU/1/23/1775 |
Rezzayo |
Island |
29.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Norge |
28.12.2023 |
|
EU/2/23/305 |
Senvelgo |
Island |
13.12.2023 |
|
EU/2/23/305 |
Senvelgo |
Liechtenstein |
30.11.2023 |
|
EU/2/23/305 |
Senvelgo |
Norge |
28.11.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
Island |
9.8.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
Norge |
12.7.2023 |
|
EU/1/23/1748 |
TALVEY |
Island |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Norge |
29.8.2023 |
|
EU/1/23/1759 |
Tepkinly |
Island |
20.10.2023 |
|
EU/1/23/1759 |
Tepkinly |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1759 |
Tepkinly |
Norge |
10.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
Island |
19.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1758 |
Tevimbra |
Norge |
10.10.2023 |
|
EU/1/23/1754 |
Tyenne |
Island |
18.10.2023 |
|
EU/1/23/1754 |
Tyenne |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1754 |
Tyenne |
Norge |
23.10.2023 |
|
EU/1/23/1745 |
Tyruko |
Island |
20.10.2023 |
|
EU/1/23/1745 |
Tyruko |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1745 |
Tyruko |
Norge |
5.10.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Island |
28.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Norge |
12.12.2023 |
|
EU/1/23/1771 |
Veoza |
Island |
18.12.2023 |
|
EU/1/23/1771 |
Veoza |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1771 |
Veoza |
Norge |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
Island |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1773 |
Vueway |
Norge |
15.12.2023 |
|
EU/1/23/1751 |
Yesafili |
Island |
19.10.2023 |
|
EU/1/23/1751 |
Yesafili |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1751 |
Yesafili |
Norge |
25.10.2023 |
|
EU/1/23/1766 |
Yorvipath |
Island |
4.12.2023 |
|
EU/1/23/1766 |
Yorvipath |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1766 |
Yorvipath |
Norge |
12.12.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Island |
12.10.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Liechtenstein |
30.9.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Norge |
11.10.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Island |
15.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Norge |
12.12.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Island |
25.10.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Liechtenstein |
31.10.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Norge |
25.10.2023 |
|
EU/1/23/1743 |
ZTALMY |
Island |
16.8.2023 |
|
EU/1/23/1743 |
ZTALMY |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1743 |
ZTALMY |
Norge |
15.8.2023 |
BILAG II
Liste over fornyede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne for perioden 1. juli – 31. december 2023:
|
EU-nummer |
Produkt |
Land |
Udstedelsesdato |
|
EU/1/21/1539 |
Abecma |
Norge |
15.8.2023 |
|
EU/1/19/1358 |
AJOVY |
Island |
28.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Liechtenstein |
30.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Norge |
20.11.2023 |
|
EU/1/18/1264 |
Alunbrig |
Island |
6.9.2023 |
|
EU/1/18/1264 |
Alunbrig |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1292 |
Apealea |
Island |
5.10.2023 |
|
EU/1/18/1292 |
Apealea |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1292 |
Apealea |
Norge |
10.10.2023 |
|
EU/2/19/249 |
Aservo EquiHaler |
Norge |
22.8.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Island |
28.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Liechtenstein |
31.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Norge |
19.12.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Island |
14.8.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Norge |
15.8.2023 |
|
EU/1/18/1352 |
Besremi |
Island |
28.12.2023 |
|
EU/1/18/1352 |
Besremi |
Liechtenstein |
31.12.2023 |
|
EU/1/18/1352 |
Besremi |
Norge |
19.12.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Island |
20.10.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Norge |
26.10.2023 |
|
EU/1/18/1314 |
Braftovi |
Island |
4.7.2023 |
|
EU/1/18/1314 |
Braftovi |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1314 |
Braftovi |
Norge |
17.7.2023 |
|
EU/1/18/1336 |
Buvidal |
Island |
15.8.2023 |
|
EU/1/18/1336 |
Buvidal |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1336 |
Buvidal |
Norge |
15.8.2023 |
|
EU/2/15/183 |
Canigen L4 |
Norge |
8.8.2023 |
|
EU/2/22/283 |
Chanaxin |
Norge |
22.8.2023 |
|
EU/2/17/222 |
Clevor |
Norge |
22.8.2023 |
|
EU/2/18/225 |
Dany’s BienenWohl |
Norge |
16.8.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
Island |
4.7.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
Norge |
17.7.2023 |
|
EU/1/13/878 |
Defitelio |
Norge |
15.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
Island |
10.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1333 |
Delstrigo |
Norge |
17.7.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Island |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Norge |
6.9.2023 |
|
EU/1/20/1437 |
Dovprela |
Island |
10.8.2023 |
|
EU/1/20/1437 |
Dovprela |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1437 |
Dovprela |
Norge |
15.8.2023 |
|
EU/1/18/1330 |
Emgality |
Island |
12.9.2023 |
|
EU/1/18/1330 |
Emgality |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1330 |
Emgality |
Norge |
6.9.2023 |
|
EU/1/20/1508 |
Enhertu |
Island |
2.11.2023 |
|
EU/1/20/1508 |
Enhertu |
Liechtenstein |
31.10.2023 |
|
EU/1/20/1508 |
Enhertu |
Norge |
30.10.2023 |
|
EU/1/18/1342 |
Erleada |
Island |
20.10.2023 |
|
EU/1/18/1342 |
Erleada |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1342 |
Erleada |
Norge |
26.10.2023 |
|
EU/2/22/284 |
Evanovo |
Norge |
12.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
Island |
28.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
Liechtenstein |
31.12.2023 |
|
EU/2/19/238 |
Felisecto Plus |
Norge |
12.12.2023 |
|
EU/2/21/277 |
Felpreva |
Norge |
18.9.2023 |
|
EU/2/19/235 |
Forceris |
Liechtenstein |
31.7.2023 |
|
EU/1/13/881 |
Fortacin |
Island |
20.10.2023 |
|
EU/1/13/881 |
Fortacin |
Liechtenstein |
30.9.2023 |
|
EU/1/13/881 |
Fortacin |
Norge |
25.10.2023 |
|
EU/1/18/1329 |
Fulphila |
Island |
18.10.2023 |
|
EU/1/18/1329 |
Fulphila |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1329 |
Fulphila |
Norge |
15.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
Island |
20.10.2023 |
|
EU/1/21/1555 |
GAVRETO |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
Norge |
26.10.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Island |
10.8.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Norge |
17.7.2023 |
|
EU/1/22/1715 |
Hemgenix |
Island |
19.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Liechtenstein |
31.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Norge |
19.12.2023 |
|
EU/1/20/1446 |
Hepcludex |
Island |
11.8.2023 |
|
EU/1/20/1446 |
Hepcludex |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1446 |
Hepcludex |
Norge |
15.8.2023 |
|
EU/1/18/1319 |
Hulio |
Island |
16.8.2023 |
|
EU/1/18/1319 |
Hulio |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1319 |
Hulio |
Norge |
21.9.2023 |
|
EU/2/18/230 |
Hydrocortisone aceponate Ecuphar |
Norge |
22.8.2023 |
|
EU/1/19/1356 |
Idacio |
Island |
27.11.2023 |
|
EU/1/19/1356 |
Idacio |
Liechtenstein |
31.10.2023 |
|
EU/1/19/1356 |
Idacio |
Norge |
8.11.2023 |
|
EU/1/20/1471 |
Idefirix |
Island |
11.8.2023 |
|
EU/1/20/1471 |
Idefirix |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1471 |
Idefirix |
Norge |
16.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
Island |
11.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1323 |
Ilumetri |
Norge |
15.8.2023 |
|
EU/2/21/280 |
Imoxat |
Norge |
15.8.2023 |
|
EU/2/20/256 |
Innovax-ND-ILT |
Norge |
1.11.2023 |
|
EU/2/18/232 |
Isemid |
Island |
18.12.2023 |
|
EU/2/18/232 |
Isemid |
Liechtenstein |
30.12.2023 |
|
EU/2/18/232 |
Isemid |
Norge |
12.12.2023 |
|
EU/1/18/1324 |
Jivi |
Island |
4.7.2023 |
|
EU/1/18/1324 |
Jivi |
Norge |
13.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
Island |
9.8.2023 |
|
EU/1/18/1302 |
Kigabeq |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
Norge |
17.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Island |
11.8.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Norge |
16.8.2023 |
|
EU/1/21/1552 |
Koselugo |
Norge |
18.7.2023 |
|
EU/2/18/234 |
Kriptazen |
Liechtenstein |
30.12.2023 |
|
EU/2/18/234 |
Kriptazen |
Norge |
20.12.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Island |
29.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Norge |
24.8.2023 |
|
EU/1/21/1603 |
Lumykras |
Island |
29.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Liechtenstein |
30.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Norge |
20.11.2023 |
|
EU/1/18/1331 |
Luxturna |
Island |
11.8.2023 |
|
EU/1/18/1331 |
Luxturna |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1331 |
Luxturna |
Norge |
15.8.2023 |
|
EU/1/18/1315 |
Mektovi |
Island |
4.7.2023 |
|
EU/1/18/1315 |
Mektovi |
Norge |
13.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
Island |
15.8.2023 |
|
EU/1/18/1301 |
Mepsevii |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
Norge |
15.8.2023 |
|
EU/2/20/259 |
MHYOSPHERE PCV ID |
Norge |
22.8.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Island |
29.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Norge |
11.12.2023 |
|
EU/1/21/1570 |
Minjuvi |
Island |
11.8.2023 |
|
EU/1/21/1570 |
Minjuvi |
Liechtenstein |
31.7.2023 |
|
EU/1/21/1570 |
Minjuvi |
Norge |
16.8.2023 |
|
EU/2/17/220 |
MiPet Easecto |
Norge |
22.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Island |
30.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Norge |
14.8.2023 |
|
EU/2/19/241 |
NASYM |
Norge |
15.9.2023 |
|
EU/1/15/1078 |
Natpar |
Norge |
25.10.2023 |
|
EU/2/20/267 |
NexGard Combo |
Norge |
22.8.2023 |
|
EU/1/16/1094 |
Ninlaro |
Island |
12.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Liechtenstein |
30.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Norge |
6.9.2023 |
|
EU/2/20/265 |
Nobivac DP Plus |
Norge |
8.8.2023 |
|
EU/1/16/1139 |
Ocaliva |
Island |
29.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Liechtenstein |
30.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Norge |
12.12.2023 |
|
EU/1/18/1341 |
Ogivri |
Island |
23.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Norge |
15.8.2023 |
|
EU/1/18/1313 |
Pelgraz |
Norge |
13.7.2023 |
|
EU/1/18/1328 |
Pelmeg |
Island |
13.12.2023 |
|
EU/1/18/1328 |
Pelmeg |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1328 |
Pelmeg |
Norge |
12.12.2023 |
|
EU/1/18/1332 |
Pifeltro |
Island |
10.8.2023 |
|
EU/1/18/1332 |
Pifeltro |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1332 |
Pifeltro |
Norge |
17.7.2023 |
|
EU/1/18/1335 |
Poteligeo |
Island |
4.10.2023 |
|
EU/1/18/1335 |
Poteligeo |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1335 |
Poteligeo |
Norge |
10.10.2023 |
|
EU/1/18/1291 |
Rizmoic |
Island |
28.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Norge |
8.11.2023 |
|
EU/1/22/1668 |
Roctavian |
Island |
14.8.2023 |
|
EU/1/22/1668 |
Roctavian |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1668 |
Roctavian |
Norge |
16.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Island |
10.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Norge |
8.8.2023 |
|
EU/1/18/1294 |
RXULTI |
Norge |
15.8.2023 |
|
EU/1/21/1594 |
Rybrevant |
Island |
15.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Norge |
25.10.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Island |
29.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Norge |
12.12.2023 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
30.11.2023 |
|
EU/1/13/901 |
Sirturo |
Norge |
7.12.2023 |
|
EU/1/13/901 |
Sirturo |
Island |
13.12.2023 |
|
EU/1/18/1318 |
Slenyto |
Norge |
15.8.2023 |
|
EU/1/22/1688 |
Spevigo |
Island |
20.10.2023 |
|
EU/1/22/1688 |
Spevigo |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1306 |
Symkevi |
Island |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Norge |
29.8.2023 |
|
EU/2/18/231 |
Syvazul BTV |
Norge |
22.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Island |
30.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Norge |
24.8.2023 |
|
EU/1/20/1492 |
Tecartus |
Island |
28.12.2023 |
|
EU/1/20/1492 |
Tecartus |
Liechtenstein |
31.12.2023 |
|
EU/1/13/837 |
Tecfidera |
Island |
19.10.2023 |
|
EU/1/13/837 |
Tecfidera |
Liechtenstein |
30.9.2023 |
|
EU/1/13/837 |
Tecfidera |
Norge |
23.10.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Island |
11.8.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Norge |
16.8.2023 |
|
EU/2/20/252 |
Tulissin |
Norge |
22.8.2023 |
|
EU/2/18/227 |
UBAC |
Norge |
22.8.2023 |
|
EU/1/18/1334 |
Vaborem |
Island |
11.8.2023 |
|
EU/1/18/1334 |
Vaborem |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1334 |
Vaborem |
Norge |
15.8.2023 |
|
EU/1/18/1350 |
Vantobra |
Island |
20.10.2023 |
|
EU/1/18/1350 |
Vantobra |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1350 |
Vantobra |
Norge |
25.10.2023 |
|
EU/2/20/266 |
Vectormune FP ILT |
Norge |
18.9.2023 |
|
EU/2/20/250 |
Vectormune FP ILT+AE |
Norge |
18.9.2023 |
|
EU/1/16/1138 |
Venclyxto |
Island |
30.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Liechtenstein |
31.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Norge |
24.8.2023 |
|
EU/2/14/169 |
Versican Plus DHPPi |
Norge |
19.9.2023 |
|
EU/2/14/164 |
Versican Plus DHPPi/L4 |
Norge |
18.9.2023 |
|
EU/2/14/163 |
Versican Plus DHPPi/L4R |
Norge |
21.9.2023 |
|
EU/2/14/171 |
Versican Plus L4 |
Norge |
18.9.2023 |
|
EU/1/18/1307 |
Verzenios |
Island |
10.8.2023 |
|
EU/1/18/1307 |
Verzenios |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1307 |
Verzenios |
Norge |
13.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
Island |
4.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1298 |
Veyvondi |
Norge |
13.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Island |
10.8.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Liechtenstein |
31.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Norge |
15.8.2023 |
|
EU/1/19/1354 |
Vizimpro |
Island |
18.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Liechtenstein |
31.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Norge |
12.12.2023 |
|
EU/1/18/1308 |
Vyxeos liposomal |
Norge |
15.8.2023 |
|
EU/1/13/873 |
Xofigo |
Island |
27.11.2023 |
|
EU/1/13/873 |
Xofigo |
Liechtenstein |
30.9.2023 |
|
EU/1/13/873 |
Xofigo |
Norge |
30.11.2023 |
|
EU/1/18/1299 |
Yescarta |
Island |
11.8.2023 |
|
EU/1/18/1299 |
Yescarta |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1299 |
Yescarta |
Norge |
15.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Island |
10.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Norge |
12.7.2023 |
|
EU/1/18/1344 |
Zirabev |
Island |
29.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Norge |
22.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Island |
29.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Liechtenstein |
30.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Norge |
12.12.2023 |
BILAG III
Liste over udvidede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet udvidet i EØS-EFTA-staterne for perioden 1. juli – 31. december 2023:
|
EU-nummer |
Produkt |
Land |
Udstedelsesdato |
|
EU/1/21/1554/004-005 |
Adtralza |
Island |
9.10.2023 |
|
EU/1/21/1554/004-005 |
Adtralza |
Norge |
25.10.2023 |
|
EU/1/20/1528/018-024 |
Comirnaty |
Norge |
31.8.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
Island |
8.9.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
Norge |
9.8.2023 |
|
EU/1/19/1365/002 |
Cufence |
Island |
14.12.2023 |
|
EU/1/19/1365/002 |
Cufence |
Norge |
12.12.2023 |
|
EU/1/15/1058/023-024 |
Entresto |
Norge |
16.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
Norge |
30.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
Island |
5.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
Island |
24.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
Norge |
10.10.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
Island |
16.8.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
Norge |
15.8.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
Island |
14.12.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
Norge |
12.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
Island |
13.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
Norge |
12.12.2023 |
|
EU/1/16/1170/017-019 |
OLUMIANT |
Island |
23.10.2023 |
|
EU/1/15/1059/008 |
Orkambi |
Island |
9.8.2023 |
|
EU/1/15/1059/008 |
Orkambi |
Norge |
12.7.2023 |
|
EU/1/13/822/006 |
PHEBURANE |
Island |
28.12.2023 |
|
EU/1/12/822/006 |
Pheburane |
Norge |
12.12.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
Norge |
16.8.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
Island |
16.8.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
Island |
8.12.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
Norge |
12.12.2023 |
|
EU/1/15/989/002 |
Tenkasi |
Island |
23.10.2023 |
|
EU/1/15/989/002 |
Tenkasi |
Norge |
10.10.2023 |
|
EU/1/21/1599/003 |
Vyepti |
Island |
18.12.2023 |
|
EU/1/21/1599/003 |
Vyepti |
Norge |
18.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
Island |
1.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
Norge |
12.12.2023 |
|
EU/1/05/319/012-017 |
Xolair |
Island |
29.11.2023 |
|
EU/1/05/319/012-017, |
Xolair |
Norge |
12.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
Island |
8.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
Norge |
12.12.2023 |
BILAG IV
Liste over tilbagetrukne markedsføringstilladelser
Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne for perioden 1. juli – 31. december 2023:
|
EU-nummer |
Produkt |
Land |
Dato for tilbagetrækning |
|
EU/2/10/118 |
Activyl |
Island |
29.11.2023 |
|
EU/2/10/118 |
Activyl |
Liechtenstein |
30.11.2023 |
|
EU/1/20/1476 |
Adakveo |
Island |
7.9.2023 |
|
EU/1/20/1476 |
Adakveo |
Liechtenstein |
31.8.2023 |
|
EU/1/20/1476 |
Adakveo |
Norge |
21.8.2023 |
|
EU/2/13/153 |
Aftovaxpur Doe |
Norge |
14.9.2023 |
|
EU/1/03/254 |
Busilvex |
Island |
20.7.2023 |
|
EU/2/11/121 |
CaniLeish |
Island |
25.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Liechtenstein |
31.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Norge |
22.11.2023 |
|
EU/1/15/1055 |
Ciambra |
Island |
25.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Liechtenstein |
31.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Norge |
28.11.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
Liechtenstein |
31.10.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
Island |
6.11.2023 |
|
EU/2/10/115 |
Comfortis |
Island |
24.8.2023 |
|
EU/2/10/115 |
Comfortis |
Norge |
21.9.2023 |
|
EU/1/21/1624 |
COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
Island |
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 |
Norge |
22.11.2023 |
|
EU/1/17/1248 |
Darunavir Krka d.d. |
Norge |
23.1.2023 (1) |
|
EU/1/21/1540 |
Dasatinib Accord |
Norge |
15.9.2023 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Norge |
15.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Island |
11.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Liechtenstein |
31.8.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Norge |
21.9.2023 |
|
EU/1/22/1644 |
Inpremzia |
Norge |
14.9.2023 |
|
EU/1/96/026 |
Invirase |
Island |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Liechtenstein |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Norge |
21.9.2023 |
|
EU/1/19/1396 |
Ivozall |
Island |
2.11.2023 |
|
EU/1/19/1396 |
Ivozall |
Liechtenstein |
31.10.2023 |
|
EU/1/19/1396 |
Ivozall |
Norge |
1.11.2023 |
|
EU/1/13/819 |
JETREA |
Island |
11.9.2023 |
|
EU/1/13/819 |
JETREA |
Liechtenstein |
31.8.2023 |
|
EU/1/13/819 |
JETREA |
Norge |
11.10.2023 |
|
EU/1/10/663 |
Lamivudine/Zidovudine Teva |
Norge |
21.9.2023 |
|
EU/1/20/1521 |
Lenalidomide Krka d.d. |
Norge |
21.9.2023 |
|
EU/1/20/1519 |
Lenalidomide Krka d.d. Novo mesto |
Liechtenstein |
30.9.2023 |
|
EU/1/09/598 |
Nevirapine Teva |
Norge |
1.11.2023 |
|
EU/1/17/1217 |
Nitisinone MDK |
Norge |
26.10.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Island |
8.9.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Liechtenstein |
31.8.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Norge |
24.8.2023 |
|
EU/1/20/1499 |
Onbevzi |
Island |
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 |
Norge |
22.11.2023 |
|
EU/1/09/571 |
Pandemic Influenza Vaccine H5N1 BAXTER |
Island |
25.10.2023 |
|
EU/1/12/757 |
Pioglitazone Teva |
Norge |
21.9.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Island |
24.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Liechtenstein |
31.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Norge |
29.11.2023 |
|
EU/1/16/1166 |
Pregabalin Zentiva k.s., |
Norge |
14.9.2023 |
|
EU/1/99/107 |
Rebetol |
Island |
26.10.2023 |
|
EU/1/99/107 |
Rebetol |
Liechtenstein |
31.10.2023 |
|
EU/1/99/107 |
Rebetol |
Norge |
2.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Island |
29.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Liechtenstein |
30.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Norge |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
Liechtenstein |
31.10.2023 |
|
EU/1/20/1478 |
Zynrelef |
Norge |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
Island |
25.10.2023 |
(1) Tilbagekaldelsen var utilsigtet blevet udeladt fra listen for første halvår 2023.
BILAG V
Liste over suspenderede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet suspenderet i EØS-EFTA-staterne for perioden 1. juli – 31. december 2023:
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EU-nummer |
Produkt |
Land |
Suspensionsdato |
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ELI: http://data.europa.eu/eli/C/2024/4358/oj
ISSN 1977-0871 (electronic edition)