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)
Date: 2025-06-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_202503366EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













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)