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Document 52025XC03366

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2025 to 31 May 2025 (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/2025/643

OJ C, C/2025/3366, 30.6.2025, ELI: http://data.europa.eu/eli/C/2025/3366/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)

ELI: http://data.europa.eu/eli/C/2025/3366/oj

European flag

Official Journal
of the European Union

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C/2025/3366

30.6.2025

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2025 to 31 May 2025

(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/2025/3366)

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

2.5.2025

Deqsiga

human normal immunoglobulin

Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich

EU/1/25/1919

Solution for infusion

J06BA02

5.5.2025

8.5.2025

Columvi

glofitamab

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/23/1742

Concentrate for solution for infusion

L01FX28

12.5.2025

8.5.2025

Lorviqua

lorlatinib

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/19/1355

Film-coated tablet

L01ED05

12.5.2025

26.5.2025

Jubereq

denosumab

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/25/1921

Solution for injection

M05BX04

27.5.2025

26.5.2025

Osvyrti

denosumab

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/25/1922

Solution for injection

M05BX04

27.5.2025

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

2.5.2025

Kizfizo

ORPHELIA Pharma

85 Boulevard Saint-Michel, 75005 Paris, France

-

5.5.2025

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

2.5.2025

Bylvay

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/21/1566

6.5.2025

2.5.2025

Calquence

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

5.5.2025

2.5.2025

Calquence

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

5.5.2025

2.5.2025

Clopidogrel Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/09/568

5.5.2025

2.5.2025

ELREXFIO

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/23/1770

5.5.2025

2.5.2025

Entresto

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/15/1058

6.5.2025

2.5.2025

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1025

6.5.2025

2.5.2025

Fingolimod Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/20/1450

13.5.2025

2.5.2025

Ongentys

Bial – Portela & Ca, SA

À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

EU/1/15/1066

5.5.2025

2.5.2025

Paxlovid

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgi

EU/1/22/1625

5.5.2025

2.5.2025

Praluent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/15/1031

5.5.2025

2.5.2025

Spexotras

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, IrelandS

EU/1/23/1781

6.5.2025

2.5.2025

TachoSil

Corza Medical GmbH

Speditionstraße 21, 40221 Düsseldorf, Deutschland

EU/1/04/277

6.5.2025

2.5.2025

Tevimbra

BeiGene Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/23/1758

5.5.2025

2.5.2025

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

5.5.2025

2.5.2025

Xydalba

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/986

5.5.2025

8.5.2025

Cystagon

Recordati Rare Diseases

Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France

EU/1/97/039

12.5.2025

8.5.2025

Esbriet

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/11/667

12.5.2025

8.5.2025

Glyxambi

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/16/1146

15.5.2025

8.5.2025

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

12.5.2025

8.5.2025

Pirfenidone axunio

axunio Pharma GmbH

Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland

EU/1/22/1655

14.5.2025

8.5.2025

Prevenar 13

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/09/590

12.5.2025

8.5.2025

RoActemra

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/08/492

12.5.2025

15.5.2025

BEQVEZ

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/24/1838

16.5.2025

15.5.2025

Korjuny

Atnahs Pharma Netherlands B. V.

Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark

EU/1/24/1826

21.5.2025

15.5.2025

Mabthera

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/98/067

16.5.2025

15.5.2025

Onpattro

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/18/1320

20.5.2025

15.5.2025

OPDIVO

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

20.5.2025

15.5.2025

Sorafenib Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/22/1696

19.5.2025

15.5.2025

Tysabri

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/06/346

16.5.2025

15.5.2025

Zilbrysq

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/23/1764

20.5.2025

16.5.2025

IXCHIQ

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/24/1828

20.5.2025

22.5.2025

Breyanzi

Bristol Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/22/1631

23.5.2025

22.5.2025

Kaftrio

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland

EU/1/20/1468

25.5.2025

22.5.2025

Kymriah

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/18/1297

23.5.2025

22.5.2025

Lumeblue

Cosmo Technologies Ltd

Riverside II, Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/20/1470

27.5.2025

22.5.2025

Mysimba

Orexigen Therapeutics Ireland Limited

9-10 Fenian Street, Dublin 2, D02 RX24, Ireland

EU/1/14/988

23.5.2025

22.5.2025

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

23.5.2025

22.5.2025

Xromi

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/19/1366

26.5.2025

26.5.2025

OPDIVO

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

28.5.2025

26.5.2025

Xofluza

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/20/1500

27.5.2025

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

2.5.2025

Pemetrexed Baxter

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1705

5.5.2025

15.5.2025

BEQVEZ

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/24/1838

16.5.2025

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

15.5.2025

DIVENCE IBR Marker Live

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/24/318

19.5.2025

15.5.2025

Felpreva

Vetoquinol S.A.

Magny-Vernois, 70200 Lure, France

EU/2/21/277

16.5.2025

22.5.2025

Newflend ND H9

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/23/296

23.5.2025

22.5.2025

Zycortal

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/15/189

5.6.2025

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


(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/2025/3366/oj

ISSN 1977-091X (electronic edition)


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