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Official Journal
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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)