This document is an excerpt from the EUR-Lex website
Document 52024XC02197
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 2024 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 2024 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 2024 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
PUB/2024/239
OJ C, C/2024/2197, 27.3.2024, ELI: http://data.europa.eu/eli/C/2024/2197/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)
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Official Journal |
EN Series C |
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C/2024/2197 |
27.3.2024 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 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/2024/2197)
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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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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9.2.2024 |
Casgevy |
exagamglogene autotemcel |
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EU/1/23/1787 |
Dispersion for infusion |
B06AX |
12.2.2024 |
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9.2.2024 |
Mevlyq |
eribulin |
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EU/1/23/1789 |
Solution for injection |
L01XX41 |
13.2.2024 |
||
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9.2.2024 |
Skyclarys |
omaveloxolone |
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EU/1/23/1786 |
Capsule, hard |
Pending |
12.2.2024 |
||
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16.2.2024 |
Ibuprofen Gen.Orph |
ibuprofen |
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EU/1/23/1791 |
Solution for injection |
C01EB16 |
21.2.2024 |
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16.2.2024 |
Pomalidomide Viatris |
pomalidomide |
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EU/1/23/1785 |
Capsule, hard |
L04AX06 |
19.2.2024 |
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16.2.2024 |
Velsipity |
etrasimod |
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EU/1/23/1790 |
Film-coated tablet |
L04AE05 |
19.2.2024 |
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19.2.2024 |
Dabigatran etexilate Leon Farma |
dabigatran etexilate |
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EU/1/23/1769 |
Capsule, hard |
B01AE07 |
21.2.2024 |
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22.2.2024 |
Holoclar |
Ex vivo expanded autologous human corneal epithelial cells containing stem cells |
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EU/1/14/987 |
Living tissue equivalent |
S01XA19 |
23.2.2024 |
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 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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1.2.2024 |
Efavirenz Teva |
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EU/1/11/742 |
5.2.2024 |
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1.2.2024 |
Hexacima |
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EU/1/13/828 |
5.2.2024 |
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1.2.2024 |
Hexyon |
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EU/1/13/829 |
2.2.2024 |
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1.2.2024 |
Inrebic |
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EU/1/20/1514 |
3.2.2024 |
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1.2.2024 |
Mirvaso |
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EU/1/13/904 |
6.2.2024 |
||
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1.2.2024 |
Mycamine |
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EU/1/08/448 |
5.2.2024 |
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1.2.2024 |
Simponi |
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EU/1/09/546 |
6.2.2024 |
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1.2.2024 |
Tafinlar |
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EU/1/13/865 |
2.2.2024 |
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1.2.2024 |
Thiotepa Riemser |
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EU/1/21/1536 |
5.2.2024 |
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1.2.2024 |
Tybost |
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EU/1/13/872 |
5.2.2024 |
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6.2.2024 |
Abecma |
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EU/1/21/1539 |
7.2.2024 |
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6.2.2024 |
Cegfila |
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EU/1/19/1409 |
7.2.2024 |
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6.2.2024 |
Intuniv |
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EU/1/15/1040 |
8.2.2024 |
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6.2.2024 |
Keppra |
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EU/1/00/146 |
7.2.2024 |
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6.2.2024 |
Nyxoid |
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EU/1/17/1238 |
7.2.2024 |
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6.2.2024 |
Sixmo |
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EU/1/19/1369 |
7.2.2024 |
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6.2.2024 |
SomaKit TOC |
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EU/1/16/1141 |
8.2.2024 |
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8.2.2024 |
Clopidogrel Teva |
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EU/1/09/540 |
9.2.2024 |
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8.2.2024 |
Coagadex |
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EU/1/16/1087 |
12.2.2024 |
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8.2.2024 |
Dynastat |
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EU/1/02/209 |
9.2.2024 |
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8.2.2024 |
QINLOCK |
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EU/1/21/1569 |
12.2.2024 |
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8.2.2024 |
Scintimun |
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EU/1/09/602 |
9.2.2024 |
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8.2.2024 |
Vaxzevria |
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EU/1/21/1529 |
9.2.2024 |
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8.2.2024 |
VidPrevtyn Beta |
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EU/1/21/1580 |
9.2.2024 |
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8.2.2024 |
Zypadhera |
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EU/1/08/479 |
9.2.2024 |
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8.2.2024 |
Zyprexa |
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EU/1/96/022 |
9.2.2024 |
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8.2.2024 |
Zyprexa Velotab |
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EU/1/99/125 |
9.2.2024 |
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9.2.2024 |
Clopidogrel Krka d.d. |
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EU/1/09/562 |
12.2.2024 |
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9.2.2024 |
Doptelet |
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EU/1/19/1373 |
14.2.2024 |
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9.2.2024 |
DuoPlavin |
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EU/1/10/619 |
12.2.2024 |
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9.2.2024 |
Esperoct |
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EU/1/19/1374 |
12.2.2024 |
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9.2.2024 |
Protopic |
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EU/1/02/201 |
13.2.2024 |
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9.2.2024 |
Rasilez |
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EU/1/07/405 |
12.2.2024 |
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9.2.2024 |
Translarna |
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EU/1/13/902 |
12.2.2024 |
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9.2.2024 |
Viagra |
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EU/1/98/077 |
15.2.2024 |
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16.2.2024 |
Arixtra |
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EU/1/02/206 |
19.2.2024 |
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16.2.2024 |
Azopt |
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EU/1/00/129 |
19.2.2024 |
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16.2.2024 |
Baqsimi |
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EU/1/19/1406 |
20.2.2024 |
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16.2.2024 |
Briviact |
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EU/1/15/1073 |
19.2.2024 |
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16.2.2024 |
Bylvay |
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EU/1/21/1566 |
19.2.2024 |
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16.2.2024 |
Cayston |
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EU/1/09/543 |
19.2.2024 |
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16.2.2024 |
Entyvio |
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EU/1/14/923 |
19.2.2024 |
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16.2.2024 |
Evoltra |
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EU/1/06/334 |
19.2.2024 |
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16.2.2024 |
Fetcroja |
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EU/1/20/1434 |
19.2.2024 |
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16.2.2024 |
Hemlibra |
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EU/1/18/1271 |
20.2.2024 |
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16.2.2024 |
Herzuma |
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EU/1/17/1257 |
19.2.2024 |
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16.2.2024 |
Imfinzi |
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EU/1/18/1322 |
19.2.2024 |
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16.2.2024 |
IMJUDO |
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EU/1/22/1713 |
19.2.2024 |
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16.2.2024 |
Imraldi |
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EU/1/17/1216 |
21.2.2024 |
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16.2.2024 |
Jylamvo |
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EU/1/17/1172 |
27.2.2024 |
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16.2.2024 |
Kaftrio |
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EU/1/20/1468 |
19.2.2024 |
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16.2.2024 |
Lupkynis |
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EU/1/22/1678 |
20.2.2024 |
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16.2.2024 |
LysaKare |
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EU/1/19/1381 |
19.2.2024 |
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16.2.2024 |
Natpar |
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EU/1/15/1078 |
19.2.2024 |
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16.2.2024 |
Pemazyre |
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EU/1/21/1535 |
21.2.2024 |
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16.2.2024 |
Pregabalin Accord |
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EU/1/15/1027 |
19.2.2024 |
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16.2.2024 |
Sarclisa |
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EU/1/20/1435 |
19.2.2024 |
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16.2.2024 |
Senshio |
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EU/1/14/978 |
19.2.2024 |
||
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16.2.2024 |
Stayveer |
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EU/1/13/832 |
19.2.2024 |
||
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16.2.2024 |
Stocrin |
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EU/1/99/111 |
19.2.2024 |
||
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16.2.2024 |
Truvada |
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EU/1/04/305 |
19.2.2024 |
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16.2.2024 |
Viread |
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EU/1/01/200 |
19.2.2024 |
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16.2.2024 |
Vydura |
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EU/1/22/1645 |
19.2.2024 |
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16.2.2024 |
Xagrid |
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EU/1/04/295 |
19.2.2024 |
||
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22.2.2024 |
Deltyba |
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EU/1/13/875 |
27.2.2024 |
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22.2.2024 |
Docetaxel Accord |
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EU/1/12/769 |
26.2.2024 |
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22.2.2024 |
Ebvallo |
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EU/1/22/1700 |
26.2.2024 |
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22.2.2024 |
Pravafenix |
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EU/1/11/679 |
23.2.2024 |
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22.2.2024 |
Skytrofa |
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EU/1/21/1607 |
23.2.2024 |
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22.2.2024 |
Spectrila |
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EU/1/15/1072 |
26.2.2024 |
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22.2.2024 |
Strensiq |
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EU/1/15/1015 |
26.2.2024 |
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22.2.2024 |
Tecentriq |
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EU/1/17/1220 |
23.2.2024 |
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23.2.2024 |
BLENREP |
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EU/1/20/1474 |
29.2.2024 |
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26.2.2024 |
Deltyba |
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EU/1/13/875 |
28.2.2024 |
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29.2.2024 |
Capecitabine medac |
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EU/1/12/802 |
1.3.2024 |
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29.2.2024 |
Posaconazole AHCL |
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EU/1/19/1380 |
1.3.2024 |
||
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29.2.2024 |
Retsevmo |
|
EU/1/20/1527 |
1.3.2024 |
||
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29.2.2024 |
Tevagrastim |
|
EU/1/08/445 |
4.3.2024 |
||
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29.2.2024 |
VidPrevtyn Beta |
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EU/1/21/1580 |
1.3.2024 |
— 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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1.2.2024 |
Sustiva |
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EU/1/99/110 |
3.2.2024 |
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9.2.2024 |
Apealea |
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EU/1/18/1292 |
14.2.2024 |
— 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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1.2.2024 |
Solensia |
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EU/2/20/269 |
2.2.2024 |
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1.2.2024 |
Solensia |
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EU/2/20/269 |
2.2.2024 |
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1.2.2024 |
Zactran |
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EU/2/08/082 |
6.2.2024 |
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29.2.2024 |
Metacam |
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EU/2/97/004 |
1.3.2024 |
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29.2.2024 |
REXXOLIDE |
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EU/2/20/263 |
6.3.2024 |
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 |
ELI: http://data.europa.eu/eli/C/2024/2197/oj
ISSN 1977-091X (electronic edition)