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Document 52025XC02785

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2025 to 30 April 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/2025/519

OJ C, C/2025/2785, 28.5.2025, ELI: http://data.europa.eu/eli/C/2025/2785/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/2025/2785/oj

European flag

Official Journal
of the European Union

EN

C series

C/2025/2785

28.5.2025

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2025 to 30 April 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/2025/2785)

—   

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

4.4.2025

Datroway

Datopotamab deruxtecan

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/25/1915

Powder for concentrate for solution for infusion

L01FX35

8.4.2025

4.4.2025

PAVBLU

Aflibercept

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, A96 F2A8, Ireland

EU/1/25/1909

Solution for injection in a pre-filled syringe

Solution for injection in a vial

S01LA05

7.4.2025

15.4.2025

LEQEMBI

Lecanemab

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/24/1891

Concentrate for solution for infusion

N06DX04

15.4.2025

23.4.2025

Filspari

Sparsentan

Vifor France

100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

EU/1/23/1788

Film-coated tablet

C09XX01

25.4.2025

23.4.2025

LYNOZYFIC

linvoseltamab

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27, Ireland

EU/1/25/1917

Concentrate for solution for infusion

L01FX

25.4.2025

23.4.2025

Vyjuvek

Beremagene geperpavec

Krystal Biotech Netherlands B.V.

Atrium Gebouw, Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland

EU/1/25/1918

Suspension and gel for gel

D03AX16

24.4.2025

25.4.2025

Trabectedin Accord

trabectedin

Accord Healthcare S.L.U.

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

EU/1/24/1902

Powder for concentrate for solution for infusion

L01CX01

29.4.2025

—   

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

3.4.2025

Ketoconazole Esteve

Esteve Pharmaceuticals S.A.

Passeig de La Zona Franca 109 Planta 4, 08038 Barcelona, España

EU/1/14/965

4.4.2025

4.4.2025

Briumvi

Neuraxpharm Pharmaceuticals, S.L.

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

EU/1/23/1730

8.4.2025

4.4.2025

Capecitabine Accord

Accord Healthcare S.L.U.

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

EU/1/12/762

7.4.2025

4.4.2025

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

7.4.2025

4.4.2025

Ebvallo

Pierre Fabre Medicament

Les Cauquillous, 81500 Lavaur, France

EU/1/22/1700

7.4.2025

4.4.2025

Ecansya

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

7.4.2025

4.4.2025

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

7.4.2025

4.4.2025

Finlee

Novartis Europharm Limited

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

EU/1/23/1767

7.4.2025

4.4.2025

Kaftrio

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/20/1468

7.4.2025

4.4.2025

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/12/782

7.4.2025

4.4.2025

Ketoconazole Esteve

Esteve Pharmaceuticals S.A.

Passeig de La Zona Franca 109 Planta 4, 08038 Barcelona, España

EU/1/14/965

8.4.2025

4.4.2025

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

7.4.2025

4.4.2025

Lenvima

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/15/1002

7.4.2025

4.4.2025

Lysodren

Esteve Pharmaceuticals S.A.

Torre Esteve Passeig Zona Franca 109, 4o 08038 Barcelona, España

EU/1/04/273

8.4.2025

4.4.2025

Ondexxya

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1345

7.4.2025

4.4.2025

RINVOQ

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

7.4.2025

4.4.2025

Rybrevant

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/21/1594

8.4.2025

4.4.2025

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

7.4.2025

4.4.2025

Waylivra

Akcea Therapeutics Ireland Ltd

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

EU/1/19/1360

7.4.2025

4.4.2025

Xenleta

Venipharm

4 Bureaux De La Colline, 92210 Saint-Cloud, France

EU/1/20/1457

7.4.2025

4.4.2025

Zercepac

Accord Healthcare S.L.U.

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

EU/1/20/1456

7.4.2025

10.4.2025

Columvi

Roche Registration GmbH

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

EU/1/23/1742

11.4.2025

10.4.2025

Flucelvax

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/24/1879

11.4.2025

14.4.2025

Arsenic trioxide Mylan

Mylan Ireland Limited

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

EU/1/20/1427

15.4.2025

14.4.2025

Livogiva

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/20/1462

15.4.2025

14.4.2025

Lunsumio

Roche Registration GmbH

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

EU/1/22/1649

15.4.2025

14.4.2025

Oyavas

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/20/1510

16.4.2025

14.4.2025

Xenleta

Venipharm

4 Bureaux De La Colline, 92210 Saint-Cloud, France

EU/1/20/1457

17.4.2025

16.4.2025

Ovaleap

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/13/871

22.4.2025

16.4.2025

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

22.4.2025

16.4.2025

Targretin

H.A.C. Pharma

Pericentre 2, 43 Avenue De La Cote De Nacre, Caen, 14000, France

EU/1/01/178

22.4.2025

16.4.2025

Vafseo

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, 58638 Iserlohn, Deutschland

EU/1/23/1725

23.4.2025

17.4.2025

Alymsys

Mabxience Research SL

C/ Manuel Pombo Angulo 28, 28050 Madrid, España

EU/1/20/1509

22.4.2025

17.4.2025

Enbrel

Pfizer Europe MA EEIG

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

EU/1/99/126

23.4.2025

17.4.2025

Glivec

Novartis Europharm Limited

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

EU/1/01/198

24.4.2025

23.4.2025

Ahzantive

Formycon AG

82152 Martinsried/Planegg, Deutschland

EU/1/24/1888

24.4.2025

23.4.2025

Apixaban Accord

Accord Healthcare S.L.U.

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

EU/1/20/1458

24.4.2025

23.4.2025

AQUMELDI

Proveca Pharma Limited

2 Dublin Landings, North Wall Quay, Dublin 1, Ireland

EU/1/23/1717

24.4.2025

23.4.2025

Insulin aspart Sanofi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1447

28.4.2025

23.4.2025

Lutathera

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France

EU/1/17/1226

28.4.2025

23.4.2025

Lyrica

Upjohn EESV

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

EU/1/04/279

25.4.2025

23.4.2025

MAVENCLAD

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

24.4.2025

23.4.2025

Neparvis

Novartis Europharm Limited

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

EU/1/16/1103

28.4.2025

23.4.2025

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

24.4.2025

23.4.2025

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

25.4.2025

23.4.2025

Spikevax

MODERNA BIOTECH SPAIN, S.L.

C/ Julián Camarillo no 31, 28037 Madrid, España

EU/1/20/1507

25.4.2025

23.4.2025

TOBI Podhaler

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/10/652

25.4.2025

23.4.2025

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

24.4.2025

23.4.2025

Upstaza

PTC Therapeutics International Limited

70 Sir John Rogerson's Quay, Dublin 2, Ireland

EU/1/22/1653

28.4.2025

25.4.2025

Axumin

Blue Earth Diagnostics Ireland Ltd

6th Floor, 2 Grand Canal Square, Dublin 2, Ireland

EU/1/17/1186

29.4.2025

25.4.2025

Cufence

Univar Solutions B.V.

Schouwburgplein 30, Rotterdam, 3012 CL, Nederland

EU/1/19/1365

30.4.2025

25.4.2025

Cuprior

Orphalan

226 Boulevard Voltaire, 75011 Paris, France

EU/1/17/1199

28.4.2025

25.4.2025

DaTSCAN

GE Healthcare B.V.

De Rondom 8, 5612 AP, Eindhoven, Nederland

EU/1/00/135

28.4.2025

25.4.2025

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

30.4.2025

25.4.2025

Fabrazyme

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/01/188

29.4.2025

25.4.2025

IBRANCE

Pfizer Europe MA EEIG

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

EU/1/16/1147

28.4.2025

25.4.2025

Intuniv

Takeda Pharmaceuticals International AG Ireland Branch

Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

EU/1/15/1040

28.4.2025

25.4.2025

Koselugo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1552

28.4.2025

25.4.2025

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

29.4.2025

25.4.2025

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/15/1059

28.4.2025

25.4.2025

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

29.4.2025

25.4.2025

Ryzneuta

Evive Biotechnology Ireland LTD

20 Kildare Street, Dublin 2, D02 T3V7, Ireland

EU/1/24/1793

2.5.2025

25.4.2025

SCENESSE

Clinuvel Europe Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/14/969

30.4.2025

25.4.2025

SOTYKTU

Bristol Myers Squibb Pharma EEIG

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

EU/1/23/1718

30.4.2025

25.4.2025

VANFLYTA

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/23/1768

29.4.2025

—   

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

10.4.2025

Zostavax

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/341

11.4.2025

14.4.2025

Arsenic trioxide Mylan

Mylan Ireland Limited

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

EU/1/20/1427

15.4.2025

14.4.2025

Regkirona

Celltrion Healthcare Hungary Kft.

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

EU/1/21/1597

16.4.2025

—   

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

2.4.2025

Omeprazole TriviumVet

omeprazole

TriviumVet DAC

Unit 1N, Block 1A, Cleaboy Business Park, Old Kilmeaden Road, Waterford, X91 DEC4, Ireland

EU/2/25/336

Gastro-resistant capsule, hard

QA02BC01

3.4.2025

23.4.2025

HEPIZOVAC

Epizootic haemorrhagic disease vaccine (inactivated)

CZ Vaccines S.A.U.

A Relva s/n – Torneiros 36410 O Porriño Pontevedra, España

EU/2/25/341

Suspension for injection

QI02AA

25.4.2025

23.4.2025

PRAZIVETIN

Praziquantel

VETHELLAS S.A.

51, 31rst AUGOUSTOU STREET, 412 21 LARISSA, Ελλάδα

EU/2/25/340

Premix for medicated feeding stuff

QP52AA01

28.4.2025

23.4.2025

Prevestrus vet

finrozole

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/25/338

Film-coated tablet

QG03XX90

25.4.2025

25.4.2025

Nobilis Multriva IBm+ND+EDS

Infectious Bronchitis, Newcastle disease and Egg Drop Syndrome virus vaccine (inactivated)

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/25/339

Emulsion for injection

QI01AA13

28.4.2025

—   

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

2.4.2025

Cardalis

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/12/142

7.4.2025

2.4.2025

Clevor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/17/222

4.4.2025

2.4.2025

Coxatab

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/22/286

4.4.2025

2.4.2025

Hydrocortisone aceponate Ecuphar

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/18/230

7.4.2025

2.4.2025

Porcilis ColiClos

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/141

3.4.2025

2.4.2025

PREVEXXION RN+HVT+IBD

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/255

3.4.2025

2.4.2025

Simparica Trio

Zoetis Belgium

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

EU/2/19/243

3.4.2025

10.4.2025

Innovax-ND-H5

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/24/315

11.4.2025

14.4.2025

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

16.4.2025

23.4.2025

Eluracat

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/23/297

25.4.2025

23.4.2025

Osurnia

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/14/170

29.4.2025

23.4.2025

Quadrisol

GROVET B.V.

Centurionbaan 140, 3769 AV Soesterberg,Nederland

EU/2/97/005

28.4.2025

23.4.2025

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

25.4.2025

23.4.2025

Suvaxyn PRRS MLV

Zoetis Belgium

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

EU/2/17/215

28.4.2025

23.4.2025

Veraflox

Elanco Animal Health GmbH

Alfred-Nobel-Str. 50, 40789 Monheim, Deutschland

EU/2/10/107

25.4.2025

—   

Withdrawal 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)

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

10.4.2025

Pirsue

Zoetis Belgium

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

EU/2/00/027

14.4.2025

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/2025/2785/oj

ISSN 1977-091X (electronic edition)

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