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Document C:2023:350:FULL
Official Journal of the European Union, C 350, 29 September 2023
Official Journal of the European Union, C 350, 29 September 2023
Official Journal of the European Union, C 350, 29 September 2023
ISSN 1977-091X |
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Official Journal of the European Union |
C 350 |
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English edition |
Information and Notices |
Volume 66 |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2023/C 350/01 |
EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
29.9.2023 |
EN |
Official Journal of the European Union |
C 350/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2023 to 31 August 2023
(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))
(2023/C 350/01)
— 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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11.8.2023 |
AQUIPTA |
atogepant |
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EU/1/23/1750 |
Tablet |
N02CD07 |
14.8.2023 |
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21.8.2023 |
TALVEY |
talquetamab |
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EU/1/23/1748 |
Solution for injection |
L01FX |
22.8.2023 |
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23.8.2023 |
Abrysvo |
Respiratory syncytial virus vaccine (bivalent, recombinant) |
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EU/1/23/1752 |
Powder and solvent for solution for injection |
J07BX05 |
24.8.2023 |
— 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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3.8.2023 |
Eladynos |
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EU/1/22/1706 |
4.8.2023 |
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3.8.2023 |
Hulio |
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EU/1/18/1319 |
4.8.2023 |
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3.8.2023 |
Palforzia |
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EU/1/20/1495 |
8.8.2023 |
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4.8.2023 |
Actelsar HCT |
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EU/1/13/817 |
7.8.2023 |
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4.8.2023 |
Clopidogrel Viatris |
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EU/1/09/568 |
8.8.2023 |
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4.8.2023 |
Hetlioz |
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EU/1/15/1008 |
9.8.2023 |
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4.8.2023 |
IMJUDO |
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EU/1/22/1713 |
7.8.2023 |
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4.8.2023 |
Lacosamide Accord |
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EU/1/17/1230 |
7.8.2023 |
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4.8.2023 |
Ogivri |
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EU/1/18/1341 |
8.8.2023 |
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4.8.2023 |
Pemetrexed Pfizer |
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EU/1/15/1057 |
7.8.2023 |
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4.8.2023 |
Refixia |
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EU/1/17/1193 |
8.8.2023 |
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4.8.2023 |
RotaTeq |
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EU/1/06/348 |
8.8.2023 |
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4.8.2023 |
Rukobia |
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EU/1/20/1518 |
8.8.2023 |
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4.8.2023 |
Tenofovir disoproxil Zentiva |
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EU/1/16/1127 |
8.8.2023 |
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4.8.2023 |
Topotecan Hospira |
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EU/1/10/633 |
7.8.2023 |
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4.8.2023 |
Viramune |
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EU/1/97/055 |
8.8.2023 |
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4.8.2023 |
Ziagen |
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EU/1/99/112 |
7.8.2023 |
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8.8.2023 |
Comirnaty |
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EU/1/20/1528 |
9.8.2023 |
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9.8.2023 |
Lenalidomide Accord |
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EU/1/18/1316 |
11.8.2023 |
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9.8.2023 |
Namuscla |
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EU/1/18/1325 |
11.8.2023 |
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9.8.2023 |
Pemetrexed Fresenius Kabi |
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EU/1/16/1115 |
14.8.2023 |
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9.8.2023 |
Roteas |
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EU/1/16/1152 |
10.8.2023 |
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11.8.2023 |
Armisarte |
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EU/1/15/1063 |
14.8.2023 |
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11.8.2023 |
Dengvaxia |
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EU/1/18/1338 |
30.8.2023 |
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11.8.2023 |
Imnovid |
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EU/1/13/850 |
14.8.2023 |
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11.8.2023 |
Invirase |
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EU/1/96/026 |
14.8.2023 |
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11.8.2023 |
Rivaroxaban Viatris |
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EU/1/21/1588 |
14.8.2023 |
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11.8.2023 |
Spikevax |
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EU/1/20/1507 |
21.8.2023 |
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11.8.2023 |
TAKHZYRO |
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EU/1/18/1340 |
18.8.2023 |
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11.8.2023 |
Venclyxto |
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EU/1/16/1138 |
14.8.2023 |
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16.8.2023 |
Calquence |
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EU/1/20/1479 |
17.8.2023 |
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16.8.2023 |
Ervebo |
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EU/1/19/1392 |
17.8.2023 |
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16.8.2023 |
Evrysdi |
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EU/1/21/1531 |
17.8.2023 |
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16.8.2023 |
EVUSHELD |
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EU/1/22/1651 |
17.8.2023 |
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16.8.2023 |
Foclivia |
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EU/1/09/577 |
17.8.2023 |
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16.8.2023 |
Mabthera |
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EU/1/98/067 |
17.8.2023 |
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16.8.2023 |
Ovaleap |
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EU/1/13/871 |
17.8.2023 |
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16.8.2023 |
Retsevmo |
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EU/1/20/1527 |
17.8.2023 |
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16.8.2023 |
Riximyo |
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EU/1/17/1184 |
17.8.2023 |
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16.8.2023 |
TECVAYLI |
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EU/1/22/1675 |
17.8.2023 |
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16.8.2023 |
Truxima |
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EU/1/16/1167 |
22.8.2023 |
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16.8.2023 |
VITRAKVI |
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EU/1/19/1385 |
17.8.2023 |
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21.8.2023 |
Duloxetine Zentiva |
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EU/1/15/1028 |
22.8.2023 |
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21.8.2023 |
OPDIVO |
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EU/1/15/1014 |
24.8.2023 |
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21.8.2023 |
Signifor |
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EU/1/12/753 |
23.8.2023 |
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23.8.2023 |
Blitzima |
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EU/1/17/1205 |
25.8.2023 |
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23.8.2023 |
Celdoxome pegylated liposomal |
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EU/1/22/1666 |
6.9.2023 |
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23.8.2023 |
Cholib |
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EU/1/13/866 |
24.8.2023 |
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23.8.2023 |
Efmody |
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EU/1/21/1549 |
29.8.2023 |
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23.8.2023 |
KEYTRUDA |
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EU/1/15/1024 |
28.8.2023 |
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23.8.2023 |
Mounjaro |
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EU/1/22/1685 |
25.8.2023 |
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23.8.2023 |
Neuraceq |
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EU/1/13/906 |
24.8.2023 |
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23.8.2023 |
PecFent |
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EU/1/10/644 |
4.9.2023 |
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23.8.2023 |
Rixathon |
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EU/1/17/1185 |
24.8.2023 |
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23.8.2023 |
Ruxience |
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EU/1/20/1431 |
24.8.2023 |
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23.8.2023 |
Symkevi |
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EU/1/18/1306 |
24.8.2023 |
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23.8.2023 |
Tadalafil Lilly |
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EU/1/17/1177 |
25.8.2023 |
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23.8.2023 |
Vargatef |
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EU/1/14/954 |
28.8.2023 |
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23.8.2023 |
ZOLSKETIL pegylated liposomal |
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EU/1/22/1629 |
24.8.2023 |
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25.8.2023 |
Caelyx pegylated liposomal |
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EU/1/96/011 |
29.8.2023 |
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25.8.2023 |
Cialis |
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EU/1/02/237 |
28.8.2023 |
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25.8.2023 |
Erleada |
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EU/1/18/1342 |
28.8.2023 |
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25.8.2023 |
Eurartesim |
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EU/1/11/716 |
28.8.2023 |
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25.8.2023 |
Fintepla |
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EU/1/20/1491 |
29.8.2023 |
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25.8.2023 |
Reyataz |
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EU/1/03/267 |
1.9.2023 |
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25.8.2023 |
Semglee |
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EU/1/18/1270 |
28.8.2023 |
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29.8.2023 |
Comirnaty |
|
EU/1/20/1528 |
30.8.2023 |
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29.8.2023 |
Spikevax |
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EU/1/20/1507 |
30.8.2023 |
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30.8.2023 |
Abevmy |
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EU/1/20/1515 |
4.9.2023 |
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30.8.2023 |
Glyxambi |
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EU/1/16/1146 |
1.9.2023 |
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30.8.2023 |
Hulio |
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EU/1/18/1319 |
4.9.2023 |
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30.8.2023 |
Kirsty |
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EU/1/20/1506 |
4.9.2023 |
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30.8.2023 |
Myclausen |
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EU/1/10/647 |
4.9.2023 |
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30.8.2023 |
Nepexto |
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EU/1/20/1436 |
4.9.2023 |
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30.8.2023 |
Ogivri |
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EU/1/18/1341 |
4.9.2023 |
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30.8.2023 |
Renvela |
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EU/1/09/521 |
31.8.2023 |
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30.8.2023 |
Synjardy |
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EU/1/15/1003 |
1.9.2023 |
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31.8.2023 |
Comirnaty |
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EU/1/20/1528 |
1.9.2023 |
— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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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16.8.2023 |
Invirase |
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EU/1/96/026 |
17.8.2023 |
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30.8.2023 |
Imatinib Koanaa |
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EU/1/21/1568 |
4.9.2023 |
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30.8.2023 |
JETREA |
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EU/1/13/819 |
31.8.2023 |
— Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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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3.8.2023 |
Adakveo |
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EU/1/20/1476 |
4.8.2023 |
— 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
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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4.8.2023 |
CYTOPOINT |
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EU/2/17/205 |
7.8.2023 |
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4.8.2023 |
MHYOSPHERE PCV ID |
|
EU/2/20/259 |
21.8.2023 |
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4.8.2023 |
NASYM |
|
EU/2/19/241 |
1.9.2023 |
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8.8.2023 |
Easotic |
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EU/2/08/085 |
10.8.2023 |
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8.8.2023 |
Versican Plus DHPPi |
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EU/2/14/169 |
29.8.2023 |
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8.8.2023 |
Versican Plus DHPPi/L4 |
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EU/2/14/164 |
29.8.2023 |
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11.8.2023 |
Felpreva |
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EU/2/21/277 |
21.8.2023 |
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11.8.2023 |
SevoFlo |
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EU/2/02/035 |
14.8.2023 |
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24.8.2023 |
Apoquel |
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EU/2/13/154 |
25.8.2023 |
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24.8.2023 |
Cimalgex |
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EU/2/10/119 |
25.8.2023 |
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24.8.2023 |
CircoMax Myco |
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EU/2/20/264 |
25.8.2023 |
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24.8.2023 |
Dexdomitor |
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EU/2/02/033 |
25.8.2023 |
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24.8.2023 |
NexGard Combo |
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EU/2/20/267 |
25.8.2023 |
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24.8.2023 |
Panacur AquaSol |
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EU/2/11/135 |
25.8.2023 |
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24.8.2023 |
RenuTend |
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EU/2/22/282 |
25.8.2023 |
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24.8.2023 |
Ypozane |
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EU/2/06/068 |
25.8.2023 |
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24.8.2023 |
Zactran |
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EU/2/08/082 |
25.8.2023 |
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24.8.2023 |
Zuprevo |
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EU/2/11/124 |
29.8.2023 |
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25.8.2023 |
Bonqat |
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EU/2/21/273 |
28.8.2023 |
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25.8.2023 |
Palladia |
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EU/2/09/100 |
1.9.2023 |
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30.8.2023 |
Porcilis PCV |
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EU/2/08/091 |
31.8.2023 |
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30.8.2023 |
Tessie |
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EU/2/21/276 |
31.8.2023 |
— Withdrawal 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)
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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24.8.2023 |
Nobivac Myxo-RHD |
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EU/2/11/132 |
28.8.2023 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
European Medicines Agency |
Domenico Scarlattilaan 6 |
1083 HS Amsterdam |
NETHERLANDS |