Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2024 to 31 December 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)
Date: 2025-02-28
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_202501267EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/1267


28.2.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2024 to 31 December 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/2025/1267)







—



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




12.1.2024


Sylvant







Recordati Netherlands B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/14/928


19.1.2024




25.1.2024


Praxbind







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/15/1056


13.2.2024




29.2.2024


Empliciti







Bristol-Myers Squibb Pharma EEIG




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






EU/1/16/1088


1.3.2024




25.4.2024


CoAprovel







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/98/086


26.4.2024




25.4.2024


Miglustat Gen.Orph







Gen.Orph




185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France






EU/1/17/1232


29.4.2024




28.6.2024


Remsima







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/13/853


16.7.2024




28.6.2024


Tandemact







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/06/366


21.8.2024




24.7.2024


DUAVIVE







Pfizer Europe MA EEIG




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






EU/1/14/960


25.7.2024




30.9.2024


Eporatio







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/09/573


2.10.2024




31.10.2024


INCRELEX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402


7.11.2024




31.10.2024


Ogivri







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1341


6.11.2024




31.10.2024


Vantobra







PARI Pharma GmbH




Moosstraße 3, 82319 Starnberg, Deutschland






EU/1/18/1350


11.11.2024




31.10.2024


Zegalogue







Novo Nordisk A/S




Novo Alle 1, 2880 Bagsvaerd, Danmark






EU/1/24/1829


6.11.2024




28.11.2024


Vizamyl







GE Healthcare AS




Nycoveien 1, 0485, Oslo, Norge






EU/1/14/941


18.12.2024




12.12.2024


Tolura







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/10/632


16.1.2025




19.12.2024


Brinavess







Advanz Pharma Limited




Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Co. Dublin, Ireland






EU/1/10/645


15.1.2025




19.12.2024


Olanzapine Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/08/475


10.1.2025




19.12.2024


Teriflunomide Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/22/1698


14.1.2025




19.12.2024


Yellox







BAUSCH + LOMB IRELAND LIMITED




3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3, Ireland






EU/1/11/692


14.1.2025




19.12.2024


Zinforo







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/12/785


20.12.2024














—



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




22.2.2024


Zoledronic acid Hospira







Pfizer Europe MA EEIG




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






EU/1/12/800


23.2.2024














—



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




30.8.2024


Ocaliva







ADVANZ PHARMA Limited




Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland






EU/1/16/1139


5.9.2024














—



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










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




5.1.2024


Credelio







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/206


8.1.2024




28.10.2024


Felpreva







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/21/277


29.10.2024




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/2025/1267/oj
ISSN 1977-091X (electronic edition)