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Document 52023XC0531(07)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2023 to 30 April 2023 (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 April 2023 to 30 April 2023 (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 April 2023 to 30 April 2023 (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/2023/635
OJ C 192, 31.5.2023, p. 1–7
(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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31.5.2023 |
EN |
Official Journal of the European Union |
C 192/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2023 to 30 April 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 192/01)
— 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 |
||
|
19.4.2023 |
AKEEGA |
niraparib / abiraterone acetate |
|
EU/1/23/1722 |
Film-coated tablet |
L01XK |
20.4.2023 |
||
|
19.4.2023 |
BEKEMV |
eculizumab |
|
EU/1/23/1727 |
Concentrate for solution for infusion |
L04AA25 |
20.4.2023 |
||
|
19.4.2023 |
Opzelura |
ruxolitinib |
|
EU/1/23/1726 |
Cream |
D11AH09 |
20.4.2023 |
||
|
24.4.2023 |
Vafseo |
vadadustat |
|
EU/1/23/1725 |
Film-coated tablet |
B03XA08 |
25.4.2023 |
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
|
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 |
||
|
12.4.2023 |
OMBLASTYS |
|
— |
14.4.2023 |
— 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 |
||
|
4.4.2023 |
Artesunate Amivas |
|
EU/1/21/1582 |
5.4.2023 |
||
|
4.4.2023 |
Capecitabine medac |
|
EU/1/12/802 |
5.4.2023 |
||
|
4.4.2023 |
Deferasirox Accord |
|
EU/1/19/1412 |
6.4.2023 |
||
|
4.4.2023 |
Lorviqua |
|
EU/1/19/1355 |
5.4.2023 |
||
|
4.4.2023 |
Nuvaxovid |
|
EU/1/21/1618 |
5.4.2023 |
||
|
4.4.2023 |
Onpattro |
|
EU/1/18/1320 |
11.4.2023 |
||
|
4.4.2023 |
Rybelsus |
|
EU/1/20/1430 |
11.4.2023 |
||
|
4.4.2023 |
Siklos |
|
EU/1/07/397 |
13.4.2023 |
||
|
12.4.2023 |
Fintepla |
|
EU/1/20/1491 |
14.4.2023 |
||
|
12.4.2023 |
Rinvoq |
|
EU/1/19/1404 |
13.4.2023 |
||
|
12.4.2023 |
Xerava |
|
EU/1/18/1312 |
13.4.2023 |
||
|
17.4.2023 |
Cablivi |
|
EU/1/18/1305 |
18.4.2023 |
||
|
17.4.2023 |
Kisplyx |
|
EU/1/16/1128 |
18.4.2023 |
||
|
19.4.2023 |
Lonquex |
|
EU/1/13/856 |
24.4.2023 |
||
|
19.4.2023 |
Lunsumio |
|
EU/1/22/1649 |
20.4.2023 |
||
|
19.4.2023 |
Tegsedi |
|
EU/1/18/1296 |
20.4.2023 |
||
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24.4.2023 |
Alimta |
|
EU/1/04/290 |
25.4.2023 |
||
|
24.4.2023 |
Axumin |
|
EU/1/17/1186 |
28.4.2023 |
||
|
24.4.2023 |
Erbitux |
|
EU/1/04/281 |
1.5.2023 |
||
|
24.4.2023 |
Farydak |
|
EU/1/15/1023 |
25.4.2023 |
||
|
24.4.2023 |
Givlaari |
|
EU/1/20/1428 |
25.4.2023 |
||
|
24.4.2023 |
Imfinzi |
|
EU/1/18/1322 |
25.4.2023 |
||
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24.4.2023 |
Imnovid |
|
EU/1/13/850 |
26.4.2023 |
||
|
24.4.2023 |
Kevzara |
|
EU/1/17/1196 |
3.5.2023 |
||
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24.4.2023 |
Ondexxya |
|
EU/1/18/1345 |
27.4.2023 |
||
|
24.4.2023 |
OPDIVO |
|
EU/1/15/1014 |
2.5.2023 |
||
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24.4.2023 |
Poteligeo |
|
EU/1/18/1335 |
2.5.2023 |
||
|
24.4.2023 |
Repaglinide Accord |
|
EU/1/11/743 |
2.5.2023 |
||
|
24.4.2023 |
Tolucombi |
|
EU/1/13/821 |
25.4.2023 |
||
|
24.4.2023 |
YERVOY |
|
EU/1/11/698 |
2.5.2023 |
||
|
24.4.2023 |
Zutectra |
|
EU/1/09/600 |
25.4.2023 |
||
|
26.4.2023 |
Arsenic trioxide medac |
|
EU/1/20/1475 |
3.5.2023 |
||
|
26.4.2023 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
|
EU/1/17/1210 |
27.4.2023 |
||
|
26.4.2023 |
Kymriah |
|
EU/1/18/1297 |
27.4.2023 |
||
|
26.4.2023 |
Luxturna |
|
EU/1/18/1331 |
27.4.2023 |
||
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26.4.2023 |
Orkambi |
|
EU/1/15/1059 |
27.4.2023 |
||
|
26.4.2023 |
Padcev |
|
EU/1/21/1615 |
1.5.2023 |
||
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26.4.2023 |
Paxlovid |
|
EU/1/22/1625 |
27.4.2023 |
||
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26.4.2023 |
Vaxneuvance |
|
EU/1/21/1591 |
28.4.2023 |
||
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26.4.2023 |
Veklury |
|
EU/1/20/1459 |
27.4.2023 |
||
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26.4.2023 |
Zavicefta |
|
EU/1/16/1109 |
3.5.2023 |
||
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27.4.2023 |
AJOVY |
|
EU/1/19/1358 |
3.5.2023 |
||
|
27.4.2023 |
Fycompa |
|
EU/1/12/776 |
28.4.2023 |
||
|
28.4.2023 |
Breyanzi |
|
EU/1/22/1631 |
2.5.2023 |
||
|
28.4.2023 |
Cotellic |
|
EU/1/15/1048 |
2.5.2023 |
||
|
28.4.2023 |
Wegovy |
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EU/1/21/1608 |
2.5.2023 |
— 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 |
||
|
4.4.2023 |
Inpremzia |
|
EU/1/22/1644 |
5.4.2023 |
— 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 |
||
|
14.4.2023 |
Innovax-ILT-IBD |
avian infectious laryngotracheitis, infectious bursal disease and Marek’s disease vaccine (live recombinant) |
|
EU/2/23/292 |
Concentrate and solvent for suspension for injection |
QI01AD18 |
17.4.2023 |
||
|
24.4.2023 |
Prolevare |
oclacitinib maleate |
|
EU/2/23/295 |
Film-coated tablet |
QD11AH90 |
25.4.2023 |
— 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 |
||
|
5.4.2023 |
Lydaxx |
|
EU/2/20/253 |
11.4.2023 |
||
|
5.4.2023 |
MHYOSPHERE PCV ID |
|
EU/2/20/259 |
12.4.2023 |
||
|
5.4.2023 |
Purevax RCP |
|
EU/2/04/052 |
12.4.2023 |
||
|
5.4.2023 |
Simparica Trio |
|
EU/2/19/243 |
13.4.2023 |
||
|
5.4.2023 |
Versican Plus Pi/L4 |
|
EU/2/14/172 |
11.4.2023 |
||
|
14.4.2023 |
Simparica Trio |
|
EU/2/19/243 |
18.4.2023 |
||
|
14.4.2023 |
Suvaxyn Circo + MH RTU |
|
EU/2/15/190 |
19.4.2023 |
||
|
14.4.2023 |
Syvazul BTV |
|
EU/2/18/231 |
17.4.2023 |
||
|
14.4.2023 |
Vectormune FP ILT + AE |
|
EU/2/20/250 |
18.4.2023 |
||
|
14.4.2023 |
Zycortal |
|
EU/2/15/189 |
21.4.2023 |
||
|
28.4.2023 |
CircoMax Myco |
|
EU/2/20/264 |
2.5.2023 |
||
|
28.4.2023 |
Kriptazen |
|
EU/2/18/234 |
5.5.2023 |
||
|
28.4.2023 |
Leucofeligen FeLV/RCP |
|
EU/2/09/097 |
4.5.2023 |
||
|
28.4.2023 |
Librela |
|
EU/2/20/261 |
2.5.2023 |
||
|
28.4.2023 |
Masivet |
|
EU/2/08/087 |
2.5.2023 |
||
|
28.4.2023 |
Suprelorin |
|
EU/2/07/072 |
4.5.2023 |
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 |