Official Journal
of the European Union
EN
C series
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Official Journal |
EN C series |
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C/2024/7468 |
30.12.2024 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2024 to 30 November 2024
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2) )
(C/2024/7468)
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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13.11.2024 |
Afqlir |
aflibercept |
|
EU/1/24/1867 |
Solution for injection |
S01LA05 |
14.11.2024 |
||
|
13.11.2024 |
Opuviz |
Aflibercept |
|
EU/1/24/1865 |
Solution for injection |
S01LA05 |
18.11.2024 |
||
|
14.11.2024 |
ELAHERE |
mirvetuximab soravtansine |
|
EU/1/24/1866 |
Concentrate for solution for infusion |
L01FX26 |
15.11.2024 |
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|
14.11.2024 |
Penbraya |
Meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed) |
|
EU/1/24/1871 |
Powder and suspension for suspension for injection |
J07AH11 |
15.11.2024 |
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|
14.11.2024 |
Pomalidomide Teva |
pomalidomide |
|
EU/1/24/1868 |
Capsule, hard |
L04AX06 |
15.11.2024 |
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|
15.11.2024 |
Fluad |
influenza vaccine (surface antigen, inactivated, adjuvanted) |
Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |
EU/1/24/1878 |
Suspension for injection |
J07BB02 |
19.11.2024 |
||
|
15.11.2024 |
Flucelvax |
influenza vaccine (surface antigen, inactivated, prepared in cell cultures) |
|
EU/1/24/1879 |
Suspension for injection |
J07BB02 |
26.11.2024 |
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|
18.11.2024 |
Hympavzi |
Marstacimab |
|
EU/1/24/1874 |
Solution for injection |
B02BX11 |
19.11.2024 |
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|
22.11.2024 |
Theralugand |
lutetium (177Lu) chloride |
|
EU/1/24/1852 |
Radiopharmaceutical precursor, solution |
V10X |
27.11.2024 |
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
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4.11.2024 |
Dupixent |
|
EU/1/17/1229 |
5.11.2024 |
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4.11.2024 |
Farydak |
|
EU/1/15/1023 |
5.11.2024 |
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4.11.2024 |
Hulio |
|
EU/1/18/1319 |
6.11.2024 |
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4.11.2024 |
Inaqovi |
|
EU/1/23/1756 |
6.11.2024 |
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4.11.2024 |
Remicade |
|
EU/1/99/116 |
5.11.2024 |
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4.11.2024 |
Synjardy |
|
EU/1/15/1003 |
5.11.2024 |
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4.11.2024 |
Vipdomet |
|
EU/1/13/843 |
5.11.2024 |
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|
13.11.2024 |
Abevmy |
|
EU/1/20/1515 |
20.11.2024 |
||
|
13.11.2024 |
Eladynos |
|
EU/1/22/1706 |
14.11.2024 |
||
|
13.11.2024 |
ELREXFIO |
|
EU/1/23/1770 |
15.11.2024 |
||
|
13.11.2024 |
MenQuadfi |
|
EU/1/20/1483 |
14.11.2024 |
||
|
13.11.2024 |
Ruxience |
|
EU/1/20/1431 |
15.11.2024 |
||
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13.11.2024 |
TAVLESSE |
|
EU/1/19/1405 |
18.11.2024 |
||
|
13.11.2024 |
Vaxelis |
|
EU/1/15/1079 |
14.11.2024 |
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13.11.2024 |
Zynlonta |
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EU/1/22/1695 |
14.11.2024 |
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14.11.2024 |
Fingolimod Mylan |
|
EU/1/21/1573 |
15.11.2024 |
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14.11.2024 |
Fulphila |
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EU/1/18/1329 |
27.11.2024 |
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14.11.2024 |
Givlaari |
|
EU/1/20/1428 |
19.11.2024 |
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14.11.2024 |
Incruse Ellipta |
|
EU/1/14/922 |
15.11.2024 |
||
|
14.11.2024 |
KIMMTRAK |
|
EU/1/22/1630 |
18.11.2024 |
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|
14.11.2024 |
Laventair Ellipta |
|
EU/1/14/899 |
15.11.2024 |
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14.11.2024 |
Lenalidomide Mylan |
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EU/1/20/1490 |
15.11.2024 |
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14.11.2024 |
Lumeblue |
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EU/1/20/1470 |
15.11.2024 |
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14.11.2024 |
Lumykras |
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EU/1/21/1603 |
15.11.2024 |
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14.11.2024 |
Rolufta Ellipta |
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EU/1/17/1174 |
15.11.2024 |
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|
14.11.2024 |
Spevigo |
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EU/1/22/1688 |
15.11.2024 |
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|
14.11.2024 |
Sugammadex Mylan |
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EU/1/21/1583 |
15.11.2024 |
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14.11.2024 |
Tarceva |
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EU/1/05/311 |
20.11.2024 |
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14.11.2024 |
Tecovirimat SIGA |
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EU/1/21/1600 |
19.11.2024 |
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14.11.2024 |
Uptravi |
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EU/1/15/1083 |
15.11.2024 |
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14.11.2024 |
Yescarta |
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EU/1/18/1299 |
15.11.2024 |
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18.11.2024 |
Akynzeo |
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EU/1/15/1001 |
19.11.2024 |
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18.11.2024 |
Apixaban Accord |
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EU/1/20/1458 |
19.11.2024 |
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18.11.2024 |
Cosentyx |
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EU/1/14/980 |
19.11.2024 |
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18.11.2024 |
Erleada |
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EU/1/18/1342 |
19.11.2024 |
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18.11.2024 |
Isturisa |
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EU/1/19/1407 |
19.11.2024 |
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18.11.2024 |
Krazati |
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EU/1/23/1744 |
19.11.2024 |
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18.11.2024 |
Lupkynis |
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EU/1/22/1678 |
19.11.2024 |
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18.11.2024 |
Nevanac |
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EU/1/07/433 |
19.11.2024 |
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18.11.2024 |
Nilemdo |
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EU/1/20/1425 |
27.11.2024 |
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18.11.2024 |
Nustendi |
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EU/1/20/1424 |
27.11.2024 |
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18.11.2024 |
Orgovyx |
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EU/1/22/1642 |
19.11.2024 |
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18.11.2024 |
Ozawade |
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EU/1/21/1546 |
19.11.2024 |
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18.11.2024 |
Praluent |
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EU/1/15/1031 |
19.11.2024 |
||
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18.11.2024 |
Pylclari |
|
EU/1/23/1746 |
21.11.2024 |
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18.11.2024 |
Simulect |
|
EU/1/98/084 |
19.11.2024 |
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18.11.2024 |
Xolair |
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EU/1/05/319 |
19.11.2024 |
||
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19.11.2024 |
Victoza |
|
EU/1/09/529 |
26.11.2024 |
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22.11.2024 |
Anoro Ellipta |
|
EU/1/14/898 |
25.11.2024 |
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22.11.2024 |
Beovu |
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EU/1/19/1417 |
25.11.2024 |
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22.11.2024 |
Briviact |
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EU/1/15/1073 |
26.11.2024 |
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22.11.2024 |
Bylvay |
|
EU/1/21/1566 |
29.11.2024 |
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22.11.2024 |
Cablivi |
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EU/1/18/1305 |
25.11.2024 |
||
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22.11.2024 |
Ebymect |
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EU/1/15/1051 |
25.11.2024 |
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22.11.2024 |
Rybelsus |
|
EU/1/20/1430 |
26.11.2024 |
||
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22.11.2024 |
SANCUSO |
|
EU/1/12/766 |
28.11.2024 |
||
|
22.11.2024 |
Saxenda |
|
EU/1/15/992 |
26.11.2024 |
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22.11.2024 |
Scintimun |
|
EU/1/09/602 |
27.11.2024 |
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|
22.11.2024 |
Vaxneuvance |
|
EU/1/21/1591 |
26.11.2024 |
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22.11.2024 |
Yselty |
|
EU/1/21/1606 |
25.11.2024 |
||
|
25.11.2024 |
Hepcludex |
|
EU/1/20/1446 |
26.11.2024 |
||
|
25.11.2024 |
Kevzara |
|
EU/1/17/1196 |
26.11.2024 |
||
|
25.11.2024 |
Kisqali |
|
EU/1/17/1221 |
26.11.2024 |
||
|
25.11.2024 |
Menveo |
|
EU/1/10/614 |
26.11.2024 |
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|
25.11.2024 |
Orgalutran |
|
EU/1/00/130 |
27.11.2024 |
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25.11.2024 |
Supemtek |
|
EU/1/20/1484 |
28.11.2024 |
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25.11.2024 |
Tevimbra |
|
EU/1/23/1758 |
26.11.2024 |
||
|
25.11.2024 |
Tigecycline Accord |
|
EU/1/19/1394 |
26.11.2024 |
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|
28.11.2024 |
Azacitidine Betapharm |
|
EU/1/19/1416 |
4.12.2024 |
||
|
28.11.2024 |
Besponsa |
|
EU/1/17/1200 |
29.11.2024 |
||
|
28.11.2024 |
Deferasirox Accord |
|
EU/1/19/1412 |
29.11.2024 |
||
|
28.11.2024 |
QUVIVIQ |
|
EU/1/22/1638 |
3.12.2024 |
||
|
28.11.2024 |
Xigduo |
|
EU/1/13/900 |
29.11.2024 |
||
|
29.11.2024 |
Ameluz |
|
EU/1/11/740 |
4.12.2024 |
||
|
29.11.2024 |
Azacitidine Mylan |
|
EU/1/20/1426 |
2.12.2024 |
||
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29.11.2024 |
Mircera |
|
EU/1/07/400 |
3.12.2024 |
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|
29.11.2024 |
Tasigna |
|
EU/1/07/422 |
2.12.2024 |
— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
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25.11.2024 |
Extavia |
|
EU/1/08/454 |
26.11.2024 |
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25.11.2024 |
PreHevbri |
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EU/1/22/1641 |
27.11.2024 |
— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
|
22.11.2024 |
BRAVECTO TriUNO |
fluralaner / moxidectin / pyrantel |
|
EU/2/24/325 |
Chewable tablet |
QP54AB52 |
28.11.2024 |
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|
22.11.2024 |
DuOtic |
Betamethasone acetate / Terbinafine |
|
EU/2/24/327 |
Ear gel |
QS02CA90 |
25.11.2024 |
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22.11.2024 |
VAXXON ND CLONE |
Newcastle disease vaccine live |
|
EU/2/24/326 |
lyophilisate and solvent for oculonasal suspension for chickens |
QI01AD06 |
27.11.2024 |
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
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22.11.2024 |
Bovilis Nasalgen-C |
|
EU/2/23/294 |
25.11.2024 |
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22.11.2024 |
Inflacam |
|
EU/2/11/134 |
26.11.2024 |
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22.11.2024 |
Poulvac Procerta HVT-IBD |
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EU/2/23/300 |
26.11.2024 |
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25.11.2024 |
Eluracat |
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EU/2/23/297 |
26.11.2024 |
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25.11.2024 |
Enteroporc Coli AC |
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EU/2/20/262 |
26.11.2024 |
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25.11.2024 |
Mometamax Ultra |
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EU/2/22/289 |
3.12.2024 |
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25.11.2024 |
Rheumocam |
|
EU/2/07/078 |
28.11.2024 |
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28.11.2024 |
CLYNAV |
|
EU/2/16/197 |
29.11.2024 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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European Medicines Agency |
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Domenico Scarlattilaan 6 |
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1083 HS Amsterdam |
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NETHERLANDS |
(1) OJ L 136, 30.4.2004, p. 1, ELI: https://data.europa.eu/eli/reg/2004/726/oj.
(2) OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.
ELI: http://data.europa.eu/eli/C/2024/7468/oj
ISSN 1977-091X (electronic edition)