This document is an excerpt from the EUR-Lex website
Document E2025G03652
Subcommittee I on the free movement of goods – Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2024
Subcommittee I on the free movement of goods – Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2024
Subcommittee I on the free movement of goods – Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2024
OJ C, C/2025/3652, 3.7.2025, ELI: http://data.europa.eu/eli/C/2025/3652/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)
|
Official Journal |
EN C series |
|
C/2025/3652 |
3.7.2025 |
Subcommittee I on the free movement of goods
Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2024
(C/2025/3652)
(Text with EEA relevance)
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July – 31 December 2024 , at their meeting on 14.3.2025:
|
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List of withdrawn marketing authorisations |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 2024:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/24/1880 |
ABSIMKY |
Liechtenstein |
31.12.2024 |
|
EU/1/24/1837 |
ADZYNMA |
Iceland |
2.9.2024 |
|
EU/1/24/1837 |
ADZYNMA |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1837 |
ADZYNMA |
Norway |
7.8.2024 |
|
EU/1/24/1867 |
Afqlir |
Iceland |
11.12.2024 |
|
EU/1/24/1867 |
Afqlir |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1867 |
Afqlir |
Norway |
18.11.2024 |
|
EU/1/24/1840 |
AKANTIOR |
Iceland |
12.9.2024 |
|
EU/1/24/1840 |
AKANTIOR |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1840 |
AKANTIOR |
Norway |
27.8.2024 |
|
EU/2/24/306 |
Alcort |
Iceland |
1.7.2024 |
|
EU/1/24/1881 |
Alhemo |
Liechtenstein |
31.12.2024 |
|
EU/1/24/1824 |
Altuvoct |
Iceland |
15.8.2024 |
|
EU/1/24/1851 |
Anzupgo |
Iceland |
15.10.2024 |
|
EU/1/24/1851 |
Anzupgo |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1851 |
Anzupgo |
Norway |
9.10.2024 |
|
EU/1/24/1835 |
Apexelsin |
Iceland |
26.8.2024 |
|
EU/1/24/1835 |
Apexelsin |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1835 |
Apexelsin |
Norway |
29.7.2024 |
|
EU/2/24/323 |
ArthriCox |
Iceland |
12.11.2024 |
|
EU/2/24/323 |
ArthriCox |
Liechtenstein |
31.10.2024 |
|
EU/1/24/1834 |
Avzivi |
Iceland |
26.8.2024 |
|
EU/1/24/1834 |
Avzivi |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1834 |
Avzivi |
Norway |
2.8.2024 |
|
EU/1/24/1847 |
Axitinib Accord |
Iceland |
15.10.2024 |
|
EU/1/24/1847 |
Axitinib Accord |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1847 |
Axitinib Accord |
Norway |
9.10.2024 |
|
EU/1/24/1841 |
Balversa |
Iceland |
12.9.2024 |
|
EU/1/24/1841 |
Balversa |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1841 |
Balversa |
Norway |
26.8.2024 |
|
EU/2/24/325 |
BRAVECTO TriUNO |
Liechtenstein |
30.11.2024 |
|
EU/2/24/325 |
BRAVECTO TriUNO |
Norway |
6.12.2024 |
|
EU/1/24/1809 |
Buprenorphine Neuraxpharm |
Liechtenstein |
31.12.2024 |
|
EU/2/24/328 |
Carprofen Orion |
Liechtenstein |
31.12.2024 |
|
EU/1/24/1833 |
Cejemly |
Iceland |
30.8.2024 |
|
EU/1/24/1833 |
Cejemly |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1833 |
Cejemly |
Norway |
29.7.2024 |
|
EU/2/24/321 |
Cepeloron |
Iceland |
11.10.2024 |
|
EU/2/24/321 |
Cepeloron |
Liechtenstein |
30.9.2024 |
|
EU/2/24/321 |
Cepeloron |
Norway |
19.9.2024 |
|
EU/2/24/320 |
Cevac Salmune ETI K |
Iceland |
12.9.2024 |
|
EU/2/24/320 |
Cevac Salmune ETI K |
Liechtenstein |
31.8.2024 |
|
EU/2/24/320 |
Cevac Salmune ETI K |
Norway |
30.8.2024 |
|
EU/2/24/322 |
Cirbloc M Hyo |
Iceland |
12.11.2024 |
|
EU/2/24/322 |
Cirbloc M Hyo |
Liechtenstein |
31.10.2024 |
|
EU/2/24/322 |
Cirbloc M Hyo |
Norway |
5.11.2024 |
|
EU/1/24/1839 |
Dasatinib Accord Healthcare |
Iceland |
26.8.2024 |
|
EU/1/24/1839 |
Dasatinib Accord Healthcare |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1839 |
Dasatinib Accord Healthcare |
Norway |
6.8.2024 |
|
EU/2/24/318 |
Divence IBR Marker Live |
Iceland |
30.8.2024 |
|
EU/2/24/318 |
Divence IBR Marker Live |
Liechtenstein |
31.8.2024 |
|
EU/2/24/318 |
Divence Ibr Marker Live |
Norway |
21.8.2024 |
|
EU/2/24/307 |
Divence Penta |
Iceland |
29.7.2024 |
|
EU/2/24/310 |
Divence Tetra |
Iceland |
14.8.2024 |
|
EU/2/24/327 |
DuOtic |
Iceland |
12.12.2024 |
|
EU/2/24/327 |
DuOtic |
Liechtenstein |
30.11.2024 |
|
EU/2/24/327 |
DuOtic |
Norway |
27.11.2024 |
|
EU/1/24/1838 |
DURVEQTIX |
Iceland |
30.8.2024 |
|
EU/1/24/1838 |
DURVEQTIX |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1838 |
DURVEQTIX |
Norway |
30.7.2024 |
|
EU/1/24/1858 |
Eksunbi |
Iceland |
17.9.2024 |
|
EU/1/24/1858 |
Eksunbi |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1858 |
Eksunbi |
Norway |
20.9.2024 |
|
EU/1/24/1866 |
ELAHERE |
Iceland |
11.12.2024 |
|
EU/1/24/1866 |
ELAHERE |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1866 |
ELAHERE |
Norway |
19.11.2024 |
|
EU/1/24/1869 |
Eltrombopag Viatris |
Liechtenstein |
31.12.2024 |
|
EU/1/24/1869 |
Eltrombopag Viatris |
Norway |
18.12.2024 |
|
EU/1/24/1842 |
Enzalutamide Viatris |
Iceland |
12.9.2024 |
|
EU/1/24/1842 |
Enzalutamide Viatris |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1842 |
Enzalutamide Viatris |
Norway |
27.8.2024 |
|
EU/1/24/1819 |
Eribulin Baxter |
Iceland |
16.8.2024 |
|
EU/1/24/1819 |
Eribulin Baxter |
Norway |
15.7.2024 |
|
EU/1/24/1846 |
EURneffy |
Iceland |
12.9.2024 |
|
EU/1/24/1846 |
EURneffy |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1846 |
EURneffy |
Norway |
27.8.2024 |
|
EU/1/24/1878 |
Fluad |
Iceland |
12.12.2024 |
|
EU/1/24/1878 |
Fluad |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1878 |
Fluad |
Norway |
3.12.2024 |
|
EU/1/24/1879 |
Flucelvax |
Iceland |
12.12.2024 |
|
EU/1/24/1879 |
Flucelvax |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1879 |
Flucelvax |
Norway |
3.12.2024 |
|
EU/1/24/1816 |
Fluenz |
Iceland |
15.8.2024 |
|
EU/1/24/1827 |
Fruzaqla |
Iceland |
16.8.2024 |
|
EU/1/24/1862 |
Fymskina |
Iceland |
16.10.2024 |
|
EU/1/24/1862 |
Fymskina |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1862 |
Fymskina |
Norway |
9.10.2024 |
|
EU/1/24/1836 |
GalliaPharm |
Iceland |
30.8.2024 |
|
EU/1/24/1836 |
GalliaPharm |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1836 |
GalliaPharm |
Norway |
8.8.2024 |
|
EU/1/24/1874 |
Hympavzi |
Iceland |
16.12.2024 |
|
EU/1/24/1874 |
Hympavzi |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1874 |
Hympavzi |
Norway |
22.11.2024 |
|
EU/1/24/1855 |
Iqirvo |
Iceland |
15.10.2024 |
|
EU/1/24/1855 |
Iqirvo |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1855 |
Iqirvo |
Norway |
8.10.2024 |
|
EU/1/24/1872 |
IMULDOSA |
Liechtenstein |
31.12.2024 |
|
EU/2/24/315 |
Innovax-ND-H5 |
Iceland |
15.8.2024 |
|
EU/1/24/1861 |
Ituxredi |
Iceland |
14.10.2024 |
|
EU/1/24/1861 |
Ituxredi |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1861 |
Ituxredi |
Norway |
9.10.2024 |
|
EU/1/24/1828 |
IXCHIQ |
Iceland |
29.8.2024 |
|
EU/1/24/1828 |
IXCHIQ |
Norway |
1.7.2024 |
|
EU/1/24/1854 |
KAYFANDA |
Iceland |
14.10.2024 |
|
EU/1/24/1854 |
KAYFANDA |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1854 |
KAYFANDA |
Norway |
9.10.2024 |
|
EU/1/24/1818 |
JERAYGO |
Iceland |
16.8.2024 |
|
EU/1/24/1818 |
JERAYGO |
Norway |
1.7.2024 |
|
EU/2/24/308 |
Lexylan |
Iceland |
1.7.2024 |
|
EU/2/24/311 |
Lotimax |
Iceland |
29.7.2024 |
|
EU/1/24/1853 |
LOQTORZI |
Iceland |
14.10.2024 |
|
EU/1/24/1853 |
LOQTORZI |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1853 |
LOQTORZI |
Norway |
9.10.2024 |
|
EU/1/24/1849 |
mRESVIA |
Iceland |
12.9.2024 |
|
EU/1/24/1849 |
mRESVIA |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1849 |
mRESVIA |
Norway |
28.8.2024 |
|
EU/1/24/1845 |
Nilotinib Accord |
Iceland |
12.9.2024 |
|
EU/1/24/1845 |
Nilotinib Accord |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1845 |
Nilotinib Accord |
Norway |
28.8.2024 |
|
EU/2/24/316 |
Nobilis Multriva RT+IBm+ND+EDS |
Iceland |
21.8.2024 |
|
EU/2/24/316 |
Nobilis Multriva RT+IBm+ND+EDS |
Liechtenstein |
31.7.2024 |
|
EU/2/24/317 |
Nobilis Multriva RT+IBm+ND+Gm+REOm |
Iceland |
29.8.2024 |
|
EU/2/24/317 |
Nobilis Multriva RT+IBm+ND+Gm+REOm |
Liechtenstein |
31.7.2024 |
|
EU/2/24/309 |
Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS |
Iceland |
14.8.2024 |
|
EU/2/24/309 |
Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1822 |
Obgemsa |
Iceland |
16.8.2024 |
|
EU/1/24/1822 |
Obgemsa |
Norway |
15.7.2024 |
|
EU/1/24/1865 |
Opuviz |
Iceland |
11.12.2024 |
|
EU/1/24/1865 |
Opuviz |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1865 |
Opuviz |
Norway |
22.11.2024 |
|
EU/1/24/1843 |
Ordspono |
Iceland |
12.9.2024 |
|
EU/1/24/1843 |
Ordspono |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1843 |
Ordspono |
Norway |
27.8.2024 |
|
EU/1/24/1863 |
Otulfi |
Iceland |
15.10.2024 |
|
EU/1/24/1863 |
Otulfi |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1863 |
Otulfi |
Norway |
9.10.2024 |
|
EU/1/24/1871 |
Penbraya |
Iceland |
11.12.2024 |
|
EU/1/24/1871 |
Penbraya |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1871 |
Penbraya |
Norway |
19.11.2024 |
|
EU/1/24/1848 |
Piasky |
Iceland |
13.9.2024 |
|
EU/1/24/1848 |
Piasky |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1848 |
Piasky |
Norway |
28.8.2024 |
|
EU/1/24/1831 |
Pomalidomide Accord |
Iceland |
29.8.2024 |
|
EU/1/24/1831 |
Pomalidomide Accord |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1831 |
Pomalidomide Accord |
Norway |
2.8.2024 |
|
EU/1/24/1832 |
Pomalidomide Krka |
Iceland |
29.8.2024 |
|
EU/1/24/1832 |
Pomalidomide Krka |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1832 |
Pomalidomide Krka |
Norway |
6.8.2024 |
|
EU/1/24/1868 |
Pomalidomide Teva |
Iceland |
11.12.2024 |
|
EU/1/24/1868 |
Pomalidomide Teva |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1868 |
Pomalidomide Teva |
Norway |
22.11.2024 |
|
EU/1/24/1830 |
Pomalidomide Zentiva |
Iceland |
29.8.2024 |
|
EU/1/24/1830 |
Pomalidomide Zentiva |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1830 |
Pomalidomide Zentiva |
Norway |
29.7.2024 |
|
EU/2/24/319 |
Porcilis PCV M Hyo ID |
Iceland |
12.9.2024 |
|
EU/2/24/319 |
Porcilis PCV M Hyo ID |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1860 |
Ranibizumab Midas |
Iceland |
11.10.2024 |
|
EU/1/24/1860 |
Ranibizumab Midas |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1860 |
Ranibizumab Midas |
Norway |
9.10.2024 |
|
EU/2/24/314 |
Respivac TRT |
Iceland |
21.8.2024 |
|
EU/1/24/1844 |
Steqeyma |
Iceland |
12.9.2024 |
|
EU/1/24/1844 |
Steqeyma |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1844 |
Steqeyma |
Norway |
28.8.2024 |
|
EU/1/24/1799 |
Tauvid |
Iceland |
13.9.2024 |
|
EU/1/24/1799 |
Tauvid |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1799 |
Tauvid |
Norway |
28.8.2024 |
|
EU/1/24/1852 |
Theralugand |
Iceland |
12.12.2024 |
|
EU/1/24/1852 |
Theralugand |
Liechtenstein |
30.11.2024 |
|
EU/1/24/1852 |
Theralugand |
Norway |
3.12.2024 |
|
EU/1/24/1825 |
Tofidence |
Iceland |
16.8.2024 |
|
EU/1/24/1825 |
Tofidence |
Norway |
15.7.2024 |
|
EU/2/24/312 |
Trilocur |
Iceland |
15.8.2024 |
|
EU/2/24/313 |
Trilorale |
Iceland |
15.8.2024 |
|
EU/1/24/1820 |
Truqap |
Iceland |
15.8.2024 |
|
EU/1/24/1864 |
Tuznue |
Iceland |
11.10.2024 |
|
EU/1/24/1864 |
Tuznue |
Liechtenstein |
30.9.2024 |
|
EU/2/24/326 |
Vaxxon ND Clone |
Iceland |
12.12.2024 |
|
EU/2/24/326 |
Vaxxon ND Clone |
Liechtenstein |
30.11.2024 |
|
EU/2/24/326 |
Vaxxon ND Clone |
Norway |
10.12.2024 |
|
EU/1/24/1857 |
Vevizye |
Iceland |
11.10.2024 |
|
EU/1/24/1857 |
Vevizye |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1857 |
Vevizye |
Norway |
9.10.2024 |
|
EU/1/24/1856 |
Vyloy |
Iceland |
11.10.2024 |
|
EU/1/24/1856 |
Vyloy |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1856 |
Vyloy |
Norway |
8.10.2024 |
|
EU/1/24/1823 |
Wezenla |
Iceland |
21.8.2024 |
|
EU/1/24/1823 |
Wezenla |
Norway |
15.7.2024 |
|
EU/1/24/1850 |
Winrevair |
Iceland |
13.9.2024 |
|
EU/1/24/1850 |
Winrevair |
Liechtenstein |
31.8.2024 |
|
EU/1/24/1850 |
Winrevair |
Norway |
28.8.2024 |
|
EU/1/24/1859 |
Yuvanci |
Iceland |
16.10.2024 |
|
EU/1/24/1859 |
Yuvanci |
Liechtenstein |
30.9.2024 |
|
EU/1/24/1859 |
Yuvanci |
Norway |
8.10.2024 |
|
EU/1/24/1829 |
Zegalogue |
Iceland |
29.8.2024 |
|
EU/1/24/1829 |
Zegalogue |
Liechtenstein |
31.7.2024 |
|
EU/1/24/1829 |
Zegalogue |
Norway |
29.7.2024 |
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 2024:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/21/1539 |
Abecma |
Iceland |
20.8.2024 |
|
EU/1/19/1415 |
Amsparity |
Iceland |
16.10.2024 |
|
EU/1/19/1415 |
Amsparity |
Liechtenstein |
30.9.2024 |
|
EU/1/19/1415 |
Amsparity |
Norway |
9.10.2024 |
|
EU/1/19/1398 |
Arsenic Trioxide Accord |
Iceland |
16.10.2024 |
|
EU/1/19/1398 |
Arsenic Trioxide Accord |
Liechtenstein |
30.9.2024 |
|
EU/1/19/1398 |
Arsenic Trioxide Accord |
Norway |
14.10.2024 |
|
EU/1/20/1473 |
AYVAKYT |
Iceland |
28.8.2024 |
|
EU/1/20/1473 |
AYVAKYT |
Liechtenstein |
31.7.2024 |
|
EU/1/20/1473 |
AYVAKYT |
Norway |
7.8.2024 |
|
EU/1/19/1413 |
Azacitidine Accord |
Liechtenstein |
31.12.2024 |
|
EU/1/19/1416 |
Azacitidine Betapharm |
Liechtenstein |
31.12.2024 |
|
EU/1/19/1416 |
Azacitidine Betapharm |
Norway |
16.12.2024 |
|
EU/1/20/1426 |
Azacitidine Mylan |
Liechtenstein |
30.11.2024 |
|
EU/1/20/1426 |
Azacitidine Mylan |
Norway |
6.12.2024 |
|
EU/1/19/1406 |
Baqsimi |
Iceland |
11.9.2024 |
|
EU/1/19/1406 |
Baqsimi |
Liechtenstein |
31.8.2024 |
|
EU/1/19/1406 |
Baqsimi |
Norway |
28.8.2024 |
|
EU/1/19/1417 |
Beovu |
Iceland |
16.10.2024 |
|
EU/1/19/1417 |
Beovu |
Liechtenstein |
30.9.2024 |
|
EU/1/19/1417 |
Beovu |
Norway |
9.10.2024 |
|
EU/1/19/1397 |
Bortezomib Fresenius Kabi |
Liechtenstein |
31.10.2024 |
|
EU/1/19/1397 |
Bortezomib Fresenius Kabi |
Norway |
21.10.2024 |
|
EU/1/22/1648 |
Carvykti |
Iceland |
20.8.2024 |
|
EU/1/19/1409 |
Cegfila |
Iceland |
11.9.2024 |
|
EU/1/19/1409 |
Cegfila |
Liechtenstein |
31.8.2024 |
|
EU/1/19/1409 |
Cegfila |
Norway |
27.8.2024 |
|
EU/1/20/1429 |
Cinacalcet Accordpharma |
Liechtenstein |
31.12.2024 |
|
EU/2/21/281 |
CircoMax |
Liechtenstein |
31.8.2024 |
|
EU/2/21/281 |
CircoMax |
Norway |
26.8.2024 |
|
EU/1/19/1395 |
Clopidogrel/Acetylsalicylic acid Viatris |
Iceland |
11.9.2024 |
|
EU/1/19/1395 |
Clopidogrel/Acetylsalicylic acid Viatris |
Liechtenstein |
31.8.2024 |
|
EU/1/19/1395 |
Clopidogrel/Acetylsalicylic acid Viatris |
Norway |
22.8.2024 |
|
EU/1/23/1742 |
Columvi |
Iceland |
30.8.2024 |
|
EU/1/23/1742 |
Columvi |
Liechtenstein |
31.5.2024 (1) |
|
EU/1/19/1365 |
Cufence |
Iceland |
18.7.2024 |
|
EU/1/19/1412 |
Deferasirox Accord |
Liechtenstein |
30.11.2024 |
|
EU/1/19/1412 |
Deferasirox Accord |
Norway |
3.12.2024 |
|
EU/1/19/1386 |
Deferasirox Mylan |
Iceland |
28.8.2024 |
|
EU/1/19/1386 |
Deferasirox Mylan |
Liechtenstein |
31.7.2024 |
|
EU/1/19/1386 |
Deferasirox Mylan |
Norway |
29.7.2024 |
|
EU/1/19/1418 |
Dexmedetomidine Accord |
Iceland |
11.12.2024 |
|
EU/1/19/1418 |
Dexmedetomidine Accord |
Liechtenstein |
31.10.2024 |
|
EU/1/19/1418 |
Dexmedetomidine Accord |
Norway |
30.10.2024 |
|
EU/1/23/1770 |
ELREXFIO |
Liechtenstein |
30.11.2024 |
|
EU/1/20/1508 |
Enhertu |
Iceland |
12.11.2024 |
|
EU/1/20/1508 |
Enhertu |
Liechtenstein |
31.10.2024 |
|
EU/1/20/1508 |
Enhertu |
Norway |
14.11.2024 |
|
EU/1/19/1389 |
Epidyolex |
Iceland |
28.8.2024 |
|
EU/1/19/1389 |
Epidyolex |
Liechtenstein |
31.7.2024 |
|
EU/1/19/1389 |
Epidyolex |
Norway |
2.8.2024 |
|
EU/1/19/1411 |
Evenity |
Iceland |
10.9.2024 |
|
EU/1/19/1411 |
Evenity |
Liechtenstein |
31.8.2024 |
|
EU/1/19/1411 |
Evenity |
Norway |
28.8.2024 |
|
EU/1/20/1433 |
Fluad Tetra |
Liechtenstein |
31.12.2024 |
|
EU/1/21/1555 |
GAVRETO |
Iceland |
16.10.2024 |
|
EU/1/21/1555 |
GAVRETO |
Liechtenstein |
30.9.2024 |
|
EU/1/21/1555 |
GAVRETO |
Norway |
18.10.2024 |
|
EU/1/19/1384 |
Giapreza |
Iceland |
18.7.2024 |
|
EU/1/20/1428 |
Givlaari |
Liechtenstein |
30.11.2024 |
|
EU/1/20/1428 |
Givlaari |
Norway |
22.11.2024 |
|
EU/1/19/1375 |
Grasustek |
Iceland |
19.7.2024 |
|
EU/1/22/1715 |
Hemgenix |
Liechtenstein |
31.12.2024 |
|
EU/1/22/1715 |
Hemgenix |
Norway |
16.12.2024 |
|
EU/2/18/226 |
HorStem |
Liechtenstein |
31.7.2024 |
|
EU/1/20/1471 |
Idefirix |
Iceland |
28.8.2024 |
|
EU/1/20/1471 |
Idefirix |
Liechtenstein |
31.7.2024 |
|
EU/1/20/1471 |
Idefirix |
Norway |
26.8.2024 |
|
EU/1/19/1390 |
Inbrija |
Iceland |
19.8.2024 |
|
EU/1/19/1407 |
Isturisa |
Iceland |
12.11.2024 |
|
EU/1/19/1407 |
Isturisa |
Liechtenstein |
31.10.2024 |
|
EU/1/19/1407 |
Isturisa |
Norway |
21.10.2024 |
|
EU/1/23/1738 |
Jaypirca |
Iceland |
28.8.2024 |
|
EU/1/23/1738 |
Jaypirca |
Liechtenstein |
31.8.2024 |
|
EU/1/23/1738 |
Jaypirca |
Norway |
22.8.2024 |
|
EU/1/22/1657 |
Kinpeygo |
Iceland |
28.8.2024 |
|
EU/1/22/1657 |
Kinpeygo |
Norway |
19.8.2024 |
|
EU/1/21/1552 |
Koselugo |
Iceland |
16.7.2024 |
|
EU/1/23/1744 |
Krazati |
Liechtenstein |
30.11.2024 |
|
EU/1/23/1744 |
Krazati |
Norway |
18.12.2024 |
|
EU/1/19/1383 |
Lacosamide UCB |
Iceland |
16.7.2024 |
|
EU/1/21/1603 |
Lumykras |
Liechtenstein |
30.11.2024 |
|
EU/1/21/1603 |
Lumykras |
Norway |
26.11.2024 |
|
EU/1/22/1649 |
Lunsumio |
Iceland |
16.7.2024 |
|
EU/1/19/1381 |
LysaKare |
Iceland |
18.7.2024 |
|
EU/1/23/1741 |
Lytgobi |
Iceland |
18.7.2024 |
|
EU/1/19/1414 |
Mayzent |
Iceland |
16.10.2024 |
|
EU/1/19/1414 |
Mayzent |
Liechtenstein |
30.9.2024 |
|
EU/1/19/1414 |
Mayzent |
Norway |
9.10.2024 |
|
EU/1/21/1570 |
Minjuvi |
Iceland |
20.8.2024 |
|
EU/1/21/1570 |
Minjuvi |
Liechtenstein |
31.7.2024 |
|
EU/2/19/247 |
Mirataz |
Liechtenstein |
31.8.2024 |
|
EU/1/20/1425 |
Nilemdo |
Liechtenstein |
30.11.2024 |
|
EU/1/20/1432 |
NUBEQA |
Iceland |
12.11.2024 |
|
EU/1/20/1432 |
NUBEQA |
Liechtenstein |
31.10.2024 |
|
EU/1/20/1432 |
NUBEQA |
Norway |
29.10.2024 |
|
EU/1/19/1364 |
Nuceiva |
Iceland |
18.7.2024 |
|
EU/1/20/1424 |
Nustendi |
Liechtenstein |
30.11.2024 |
|
EU/1/20/1424 |
Nustendi |
Norway |
3.12.2024 |
|
EU/1/21/1618 |
Nuvaxovid |
Iceland |
10.10.2024 |
|
EU/1/21/1618 |
Nuvaxovid |
Norway |
16.9.2024 |
|
EU/1/19/1362 |
PALYNZIQ |
Iceland |
18.7.2024 |
|
EU/1/16/1089 |
Pandemic influenza vaccine H5N1 AstraZeneca |
Iceland |
18.7.2024 |
|
EU/1/19/1379 |
Posaconazole Accord |
Iceland |
16.7.2024 |
|
EU/1/19/1393 |
Quofenix |
Iceland |
10.9.2024 |
|
EU/1/19/1393 |
Quofenix |
Liechtenstein |
31.8.2024 |
|
EU/1/19/1393 |
Quofenix |
Norway |
28.8.2024 |
|
EU/1/19/1420 |
Recarbrio |
Iceland |
16.10.2024 |
|
EU/1/19/1420 |
Recarbrio |
Liechtenstein |
30.9.2024 |
|
EU/1/19/1420 |
Recarbrio |
Norway |
9.10.2024 |
|
EU/1/19/1400 |
Rhokiinsa |
Iceland |
24.9.2024 |
|
EU/1/19/1400 |
Rhokiinsa |
Liechtenstein |
30.9.2024 |
|
EU/1/19/1400 |
Rhokiinsa |
Norway |
18.9.2024 |
|
EU/1/19/1404 |
RINVOQ |
Iceland |
16.10.2024 |
|
EU/1/19/1404 |
RINVOQ |
Liechtenstein |
30.9.2024 |
|
EU/1/19/1404 |
RINVOQ |
Norway |
9.10.2024 |
|
EU/1/22/1668 |
Roctavian |
Iceland |
10.9.2024 |
|
EU/1/22/1668 |
Roctavian |
Liechtenstein |
31.8.2024 |
|
EU/1/20/1460 |
Rozlytrek |
Iceland |
18.7.2024 |
|
EU/1/20/1431 |
Ruxience |
Liechtenstein |
30.11.2024 |
|
EU/1/20/1431 |
Ruxience |
Norway |
5.12.2024 |
|
EU/1/20/1430 |
Rybelsus |
Liechtenstein |
30.11.2024 |
|
EU/1/20/1430 |
Rybelsus |
Norway |
3.12.2024 |
|
EU/1/21/1594 |
Rybrevant |
Iceland |
20.8.2024 |
|
EU/1/21/1594 |
Rybrevant |
Liechtenstein |
30.6.2024 (2) |
|
EU/1/14/978 |
Senshio |
Iceland |
16.10.2024 |
|
EU/1/14/978 |
Senshio |
Liechtenstein |
31.10.2024 |
|
EU/1/14/978 |
Senshio |
Norway |
8.10.2024 |
|
EU/1/13/901 |
Sirturo |
Iceland |
20.8.2024 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
30.6.2024 (3) |
|
EU/1/22/1688 |
Spevigo |
Liechtenstein |
30.11.2024 |
|
EU/1/22/1688 |
Spevigo |
Norway |
10.10.2024 (4) 19.11.2024 |
|
EU/1/19/1410 |
Spravato |
Iceland |
10.9.2024 |
|
EU/1/19/1410 |
Spravato |
Liechtenstein |
31.8.2024 |
|
EU/1/19/1410 |
Spravato |
Norway |
28.8.2024 |
|
EU/1/23/1748 |
TALVEY |
Iceland |
19.8.2024 |
|
EU/1/19/1377 |
Talzenna |
Iceland |
16.7.2024 |
|
EU/1/19/1405 |
TAVLESSE |
Liechtenstein |
30.11.2024 |
|
EU/1/19/1405 |
TAVLESSE |
Norway |
19.11.2024 |
|
EU/1/22/1675 |
Tecvayli |
Iceland |
19.8.2024 |
|
EU/1/23/1759 |
Tepkinly |
Iceland |
20.8.2024 |
|
EU/1/23/1759 |
Tepkinly |
Liechtenstein |
31.7.2024 |
|
EU/1/23/1759 |
Tepkinly |
Norway |
1.8.2024 |
|
EU/1/19/1394 |
Tigecycline Accord |
Liechtenstein |
30.11.2024 |
|
EU/1/19/1419 |
Trepulmix |
Liechtenstein |
31.12.2024 |
|
EU/1/19/1419 |
Trepulmix |
Norway |
20.12.2024 |
|
EU/1/19/1371 |
ULTOMIRIS |
Iceland |
18.7.2024 |
|
EU/1/19/1385 |
VITRAKVI |
Iceland |
22.7.2024 |
|
EU/1/19/1385 |
VITRAKVI |
Liechtenstein |
31.7.2024 |
|
EU/1/19/1385 |
VITRAKVI |
Norway |
29.7.2024 |
|
EU/1/19/1399 |
Xospata |
Iceland |
20.8.2024 |
|
EU/1/19/1399 |
Xospata |
Norway |
10.7.2024 |
|
EU/1/19/1366 |
Xromi |
Iceland |
18.7.2024 |
|
EU/1/14/938 |
Zydelig |
Iceland |
20.8.2024 |
|
EU/1/14/938 |
Zydelig |
Norway |
1.7.2024 |
|
EU/1/22/1695 |
Zynlonta |
Liechtenstein |
30.11.2024 |
|
EU/1/22/1695 |
Zynlonta |
Norway |
27.11.2024 |
(1) Authorisation was unintentionally omitted from the list for the 1st half of 2024.
(2) Authorisation was unintentionally omitted from the list for the 1st half of 2024.
(3) Authorisation was unintentionally omitted from the list for the 1st half of 2024.
(4) The authorisation was unintentionally delayed and applied retroactively for 2024. With the authorisation dated 19.11.2024, the authorisation is now renewed.
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 2024:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/12/809/019-020 |
Betmiga |
Iceland |
11.9.2024 |
|
EU/1/12/809/019-020 |
Betmiga |
Norway |
28.8.2024 |
|
EU/1/21/1575/009-012 |
Bimzelx |
Iceland |
2.9.2024 |
|
EU/1/21/1575/009-012 |
Bimzelx |
Norway |
7.8.2024 |
|
EU/1/14/974/004 |
Cerdelga |
Norway |
16.12.2024 |
|
EU/1/15/1036/003 |
Cresemba |
Iceland |
11.9.2024 |
|
EU/1/15/1036/003 |
Cresemba |
Norway |
27.8.2024 |
|
EU/1/20/1528/037-042 |
Comirnaty KP 2 |
Norway |
2.10.2024 |
|
EU/1/11/736/002 |
EDURANT |
Iceland |
17.10.2024 |
|
EU/1/11/736/002 |
EDURANT |
NORWAY |
9.10.2024 |
|
EU/1/11/691/016-019 |
Eliquis |
Iceland |
2.9.2024 |
|
EU/1/11/691/016-019 |
Eliquis |
Norway |
6.8.2024 |
|
EU/1/18/1315/003-004 |
Mektovi |
Iceland |
19.8.2024 |
|
EU/1/10/614/005-006 |
Menveo |
Iceland |
10.12.2024 |
|
EU/1/10/614/005-006 |
Menveo |
Norway |
3.12.2024 |
|
EU/1/17/1231/003 |
Ocrevus |
Iceland |
19.8.2024 |
|
EU/1/17/1231/003 |
Ocrevus |
Norway |
22.7.2024 |
|
EU/1/13/893/004 |
Opsumit |
Norway |
4.12.2024 |
|
EU/1/13/893/004 |
Opsumit |
Iceland |
17.10.2024 |
|
EU/1/17/1209/043-050 |
Reagila |
Norway |
26.8.2024 |
|
EU/1/20/1460/003 |
Rozlytrek |
Iceland |
19.8.2024 |
|
EU/1/20/1460/003 |
Rozlytrek |
Norway |
1.7.2024 |
|
EU/1/20/1430/016-030 |
Rybelsus |
Norway |
7.8.2024 |
|
EU/1/19/1361/007 |
Skyrizi |
Iceland |
2.9.2024 |
|
EU/1/12/793/005-007 |
XALKORI |
Iceland |
11.9.2024 |
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 2024:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/17/1261 |
Alofisel |
Liechtenstein |
13.12.2024 |
|
EU/1/17/1261 |
Alofisel |
Norway |
18.12.2024 |
|
EU/1/09/559 |
Clopidogrel Taw Pharma |
Iceland |
11.11.2024 |
|
EU/1/09/559 |
Clopidogrel Taw Pharma |
Liechtenstein |
24.10.2024 |
|
EU/1/09/559 |
Clopidogrel Taw Pharma |
Norway |
24.10.2024 |
|
EU/1/12/750 |
Esmya |
Iceland |
27.8.2024 |
|
EU/1/12/750 |
Esmya |
Liechtenstein |
18.7.2024 |
|
EU/1/12/750 |
Esmya |
Norway |
13.8.2024 |
|
EU/1/08/473 |
Evicel |
Iceland |
21.8.2024 |
|
EU/1/08/473 |
Evicel |
Liechtenstein |
5.7.2024 |
|
EU/1/08/473 |
Evicel |
Norway |
13.8.2024 |
|
EU/1/08/454 |
Extavia |
Liechtenstein |
25.11.2024 |
|
EU/1/08/454 |
Extavia |
Norway |
25.11.2024 |
|
EU/1/14/983 |
Exviera |
Iceland |
16.10.2024 |
|
EU/1/14/983 |
Exviera |
Liechtenstein |
25.9.2024 |
|
EU/1/14/983 |
Exviera |
Norway |
16.10.2024 |
|
EU/2/96/002 |
Fevaxyn Pentofel |
Iceland |
11.11.2024 |
|
EU/2/96/002 |
Fevaxyn Pentofel |
Liechtenstein |
4.10.2024 |
|
EU/2/96/002 |
Fevaxyn Pentofel |
Norway |
13.11.2024 |
|
EU/1/21/1555 |
GAVRETO |
Liechtenstein |
24.10.2024 |
|
EU/1/21/1555 |
GAVRETO |
Norway |
27.11.2024 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Iceland |
16.10.2024 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Liechtenstein |
27.9.2024 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Norway |
17.10.2024 |
|
EU/1/20/1525 |
JCOVDEN |
Iceland |
28.8.2024 |
|
EU/1/20/1525 |
JCOVDEN |
Liechtenstein |
26.7.2024 |
|
EU/1/20/1525 |
JCOVDEN |
Norway |
7.8.2024 |
|
EU/1/14/955 |
Lymphoseek |
Iceland |
21.8.2024 |
|
EU/1/14/955 |
Lymphoseek |
Liechtenstein |
30.6.2024 (1) |
|
EU/1/14/955 |
Lymphoseek |
Norway |
12.8.2024 |
|
EU/1/18/1283 |
Pemetrexed Krka |
Iceland |
21.8.2024 |
|
EU/1/18/1283 |
Pemetrexed Krka |
Norway |
12.8.2024 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Iceland |
11.11.2024 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Liechtenstein |
9.10.2024 |
|
EU/1/15/1037 |
Pemetrexed Sandoz |
Norway |
13.11.2024 |
|
EU/1/22/1641 |
PreHevbri |
Liechtenstein |
25.11.2024 |
|
EU/1/22/1641 |
PreHevbri |
Norway |
6.12.2024 |
|
EU/1/13/826 |
Memantine LEK |
Iceland |
23.9.2024 |
|
EU/1/13/826 |
Memantine LEK |
Liechtenstein |
6.9.2024 |
|
EU/1/13/826 |
Memantine LEK |
Norway |
6.9.2024 |
|
EU/1/18/1290 |
Nityr |
Iceland |
21.8.2024 |
|
EU/1/18/1290 |
Nityr |
Norway |
12.8.2024 |
|
EU/1/20/1485 |
NYXTHRACIS |
Iceland |
28.8.2024 |
|
EU/1/20/1485 |
NYXTHRACIS |
Liechtenstein |
2.8.2024 |
|
EU/1/20/1485 |
NYXTHRACIS |
Norway |
8.8.2024 |
|
EU/2/98/009 |
Suvaxyn Aujeszky 783 + O/W |
Iceland |
11.11.2024 |
|
EU/2/98/009 |
Suvaxyn Aujeszky 783 + O/W |
Liechtenstein |
4.10.2024 |
|
EU/2/98/009 |
Suvaxyn Aujeszky 783 + O/W |
Norway |
13.11.2024 |
|
EU/1/11/719 |
Telmisartan Teva Pharma |
Iceland |
19.7.2024 |
|
EU/1/24/1797 |
Tizveni |
Iceland |
21.8.2024 |
|
EU/1/24/1797 |
Tizveni |
Liechtenstein |
5.7.2024 |
|
EU/1/24/1797 |
Tizveni |
Norway |
13.8.2024 |
|
EU/1/14/982 |
Viekirax |
Iceland |
16.10.2024 |
|
EU/1/14/982 |
Viekirax |
Liechtenstein |
25.9.2024 |
|
EU/1/14/982 |
Viekirax |
Norway |
17.10.2024 |
|
EU/1/03/264 |
Zevalin |
Iceland |
2.9.2024 |
|
EU/1/03/264 |
Zevalin |
Liechtenstein |
31.01.2024 (2) |
|
EU/1/12/800 |
Zoledronic acid Hospira |
Norway |
1.8.2024 |
(1) Authorisation was unintentionally omitted from the list for the 1st half of 2024.
(2) Authorisation was unintentionally omitted from the list for the 1st half of 2024.
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 2024:
|
EU-Number |
Product |
Country |
Date of suspension |
|
EU/1/21/1622 |
Oxbryta |
Iceland |
17.10.2024 |
|
EU/1/21/1622 |
Oxbryta |
Norway |
9.10.2024 |
|
EU/2/12/145 |
Kexxtone |
Iceland |
19.7.2024 |
ELI: http://data.europa.eu/eli/C/2025/3652/oj
ISSN 1977-091X (electronic edition)