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Document 52025XC00476

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 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)

PUB/2025/58

OJ C, C/2025/476, 31.1.2025, ELI: http://data.europa.eu/eli/C/2025/476/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/2025/476/oj

European flag

Official Journal
of the European Union

EN

C series

C/2025/476

31.1.2025

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 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/2025/476)

—   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

12.12.2024

ABSIMKY

Ustekinumab

Accord Healthcare S.L.U.

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

EU/1/24/1880

Concentrate for solution for infusion

Solution for injection in a pre-filled syringe

L04AC05

13.12.2024

12.12.2024

Eltrombopag Viatris

eltrombopag

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/24/1869

Film-coated tablet

B02BX05

13.12.2024

12.12.2024

IMULDOSA

ustekinumab

Accord Healthcare S.L.U.

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

EU/1/24/1872

Concentrate for solution for infusion

Solution for injection

L04AC05

16.12.2024

13.12.2024

Alhemo

concizumab

Novo Nordisk A/S

Novo Alle 1, 2880 Bagsvaerd, Danmark

EU/1/24/1881

Solution for injection

B02BX10

16.12.2024

19.12.2024

Buprenorphine Neuraxpharm

buprenorphine

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España

EU/1/24/1809

Sublingual film

N07BC01

20.12.2024

—   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

16.12.2024

Syfovre

Apellis Europe B.V.

Piet Heinkade 55, Amsterdam, Noord-Holland 1019 GM, Nederland

-

19.12.2024

19.12.2024

Masitinib AB Science

AB Science

3 avenue George V, 75008 Paris, France

-

10.1.2025

—   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

4.12.2024

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

5.12.2024

4.12.2024

Hemgenix

CSL Behring GmbH

D-35041 Marburg, Deutschland

EU/1/22/1715

10.12.2024

4.12.2024

Hexacima

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/13/828

5.12.2024

4.12.2024

Hexyon

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/13/829

5.12.2024

4.12.2024

Hyftor

Plusultra pharma GmbH

Fritz-Vomfelde-Str. 36, 40547 Düsseldorf, Deutschland

EU/1/23/1723

12.12.2024

4.12.2024

Vevizye

Laboratoires Thea

12 Rue Louis Bleriot, 63100 Clermont-Ferrand, France

EU/1/24/1857

5.12.2024

4.12.2024

Xeljanz

Pfizer Europe MA EEIG

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

EU/1/17/1178

6.12.2024

6.12.2024

Cerdelga

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/974

10.12.2024

9.12.2024

Apretude

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/23/1760

10.12.2024

9.12.2024

Feraccru

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/15/1075

13.12.2024

9.12.2024

Olanzapine Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/08/475

11.12.2024

9.12.2024

Tegsedi

Akcea Therapeutics Ireland Ltd

St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland

EU/1/18/1296

10.12.2024

11.12.2024

Rivastigmine Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/09/599

13.12.2024

12.12.2024

Abiraterone Mylan

Mylan Pharmaceuticals Limited

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

EU/1/21/1571

16.12.2024

12.12.2024

Alimta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/290

17.12.2024

12.12.2024

Armisarte

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/15/1063

16.12.2024

12.12.2024

BIMERVAX

Hipra Human Health, S.L.U.

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

EU/1/22/1709

13.12.2024

12.12.2024

Bridion

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

13.12.2024

12.12.2024

Cinacalcet Accordpharma

Accord Healthcare S.L.U.

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

EU/1/20/1429

13.12.2024

12.12.2024

Dengvaxia

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/18/1338

16.12.2024

12.12.2024

Hukyndra

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/21/1589

13.12.2024

12.12.2024

Imlygic

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

13.12.2024

12.12.2024

Keppra

UCB Pharma S.A.

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

EU/1/00/146

16.12.2024

12.12.2024

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

13.12.2024

12.12.2024

Nintedanib Accord

Accord Healthcare S.L.U.

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

EU/1/24/1803

13.12.2024

12.12.2024

Opdualag

Bristol Myers Squibb Pharma EEIG

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

EU/1/22/1679

16.12.2024

12.12.2024

Pemetrexed Accord

Accord Healthcare S.L.U.

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

EU/1/15/1071

16.12.2024

12.12.2024

Prometax

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/98/092

18.12.2024

12.12.2024

Refixia

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1193

16.12.2024

12.12.2024

Rivastigmine HEXAL

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/09/589

13.12.2024

12.12.2024

Sevelamer carbonate Winthrop

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/14/952

16.12.2024

12.12.2024

Skytrofa

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

13.12.2024

12.12.2024

Spravato

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

16.12.2024

12.12.2024

Tepkinly

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/23/1759

16.12.2024

12.12.2024

Tibsovo

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/23/1728

13.12.2024

12.12.2024

Toujeo

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

16.12.2024

12.12.2024

Valdoxan

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/08/499

16.12.2024

12.12.2024

Vocabria

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/20/1481

16.12.2024

12.12.2024

Vueway

Bracco Imaging SPA

Via Egidio Folli, 50 20134 Milano, Italia

EU/1/23/1773

13.12.2024

12.12.2024

Zykadia

Novartis Europharm Limited

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

EU/1/15/999

17.12.2024

13.12.2024

CellCept

Roche Registration GmbH

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

EU/1/96/005

16.12.2024

13.12.2024

Evkeeza

Ultragenyx Germany GmbH

Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland

EU/1/21/1551

16.12.2024

13.12.2024

Teriflunomide Viatris

Mylan Pharmaceuticals Limited

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

EU/1/22/1698

16.12.2024

13.12.2024

Trepulmix

SciPharm Sàrl

7, Fausermillen, 6689 Mertert, Luxembourg

EU/1/19/1419

17.12.2024

16.12.2024

Gilenya

Novartis Europharm Limited

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

EU/1/11/677

17.12.2024

19.12.2024

Azacitidine Accord

Accord Healthcare S.L.U.

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

EU/1/19/1413

20.12.2024

19.12.2024

Cinacalcet Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/15/1054

20.12.2024

19.12.2024

Erbitux

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/04/281

20.12.2024

19.12.2024

Erelzi

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

7.1.2025

19.12.2024

Exelon

Novartis Europharm Limited

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

EU/1/98/066

7.1.2025

19.12.2024

Fluad Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/20/1433

20.12.2024

19.12.2024

Libmyris

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/21/1590

20.12.2024

19.12.2024

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27, Ireland

EU/1/19/1376

20.12.2024

19.12.2024

Litak

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/04/275

20.12.2024

19.12.2024

Lyrica

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/04/279

7.1.2025

19.12.2024

Omvoh

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/23/1736

20.12.2024

19.12.2024

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

20.12.2024

19.12.2024

Palforzia

STALLERGENES

6 rue Alexis de Tocqueville, 92160 Antony, France

EU/1/20/1495

20.12.2024

19.12.2024

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/16/1115

20.12.2024

19.12.2024

Relistor

Bausch Health Ireland Limited

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

EU/1/08/463

7.1.2025

19.12.2024

Renvela

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/09/521

20.12.2024

19.12.2024

Rivaroxaban Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/21/1588

20.12.2024

19.12.2024

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Industriestraße 18, 83607 Holzkirchen, Deutschland

EU/1/09/585

23.12.2024

19.12.2024

Rybrevant

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/21/1594

20.12.2024

19.12.2024

Sitagliptin/Metformin hydrochloride Mylan

Mylan Pharmaceuticals Limited

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

EU/1/21/1619

20.12.2024

19.12.2024

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

20.12.2024

19.12.2024

Trazimera

Pfizer Europe MA EEIG

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

EU/1/18/1295

20.12.2024

19.12.2024

Vabysmo

Roche Registration GmbH

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

EU/1/22/1683

20.12.2024

19.12.2024

Vidaza

Bristol Myers Squibb Pharma EEIG

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

EU/1/08/488

20.12.2024

19.12.2024

YERVOY

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

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

13.12.2024

Alofisel

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/17/1261

13.12.2024

—   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

19.12.2024

Carprofen Orion

carprofen

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/24/328

Chewable tablet

Solution for injection

QM01AE91

20.12.2024

—   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

19.12.2024

Daxocox

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/21/270

28.12.2024

19.12.2024

Equisolon

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/14/161

23.12.2024

19.12.2024

Locatim

MELCHIOR SANTE ANIMALE

5 Rue Victor Hugo, 69002 Lyon, France

EU/2/99/011

20.12.2024

19.12.2024

Simparica Trio

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/19/243

20.12.2024

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/2025/476/oj

ISSN 1977-091X (electronic edition)

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