Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2025 to 31 March 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/2025/1955)

— 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

6.3.2025

Wainzua

eplontersen

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/24/1875

Solution for injection in pre-filled pen

N07XX21

7.3.2025

Rytelo

imetelstat

Geron Netherlands B.V.

Naritaweg 165, Noord-Holland, 1043 BW Amsterdam, Nederland

EU/1/24/1894

Powder and solvent for concentrate for solution for infusion

L01XX80

11.3.2025

24.3.2025

CAPVAXIVE

Pneumococcal polysaccharide conjugate vaccine (21-valent)

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/25/1913

Solution for injection

J07AL02

25.3.2025

28.3.2025

Dyrupeg

Pegfilgrastim

CuraTeQ Biologics s.r.o

Trtinova 260/1, Cakovice, 19600 Prague 9, Česká republika

EU/1/25/1914

Solution for injection

L03AA13

31.3.2025

28.3.2025

Eltrombopag Accord

eltrombopag

Accord Healthcare S.L.U.

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

EU/1/24/1903

Film-coated tablet

B02BX05

1.4.2025

28.3.2025

Tivdak

Tisotumab vedotin

Pfizer Europe MA EEIG

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

EU/1/25/1911

Powder for concentrate for solution for infusion

L01FX23

31.3.2025

— 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

6.3.2025

LIVTENCITY

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/22/1672

7.3.2025

Gencebok

Gennisium Pharma

Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France

EU/1/20/1465

12.3.2025

7.3.2025

Incellipan

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/24/1807

10.3.2025

7.3.2025

RXULTI

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/18/1294

10.3.2025

7.3.2025

Uplizna

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/1602

10.3.2025

Cejemly

CStone Pharmaceuticals Ireland Limited

117-126 Sheriff Street Upper Dublin 1, D01 YC43, Ireland

EU/1/24/1833

11.3.2025

12.3.2025

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

13.3.2025

12.3.2025

Breyanzi

Bristol Myers Squibb Pharma EEIG

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

EU/1/22/1631

14.3.2025

12.3.2025

Daxas

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/636

13.3.2025

12.3.2025

Enjaymo

Recordati Rare Diseases

Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France

EU/1/22/1687

14.3.2025

12.3.2025

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

14.3.2025

12.3.2025

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/03/269

13.3.2025

12.3.2025

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

13.3.2025

12.3.2025

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051

13.3.2025

12.3.2025

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

13.3.2025

12.3.2025

Relvar Ellipta

GlaxoSmithKline Trading Services Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

EU/1/13/886

17.3.2025

12.3.2025

Revinty Ellipta

GlaxoSmithKline Trading Services Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

EU/1/14/929

17.3.2025

12.3.2025

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

17.3.2025

BYANNLI

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1453

19.3.2025

17.3.2025

Scintimun

TELIX INNOVATIONS

Rue de Hermée 255, 4040 Herstal, Belgique

EU/1/09/602

20.3.2025

17.3.2025

Slenyto

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/18/1318

19.3.2025

Rystiggo

UCB Pharma S.A.

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

EU/1/23/1780

1.4.2025

20.3.2025

Lorviqua

Pfizer Europe MA EEIG

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

EU/1/19/1355

21.3.2025

20.3.2025

Nexviadyme

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1579

24.3.2025

20.3.2025

Ximluci

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/22/1691

21.3.2025

24.3.2025

Azacitidine Mylan

Mylan Pharmaceuticals Limited

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

EU/1/20/1426

27.3.2025

24.3.2025

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

26.3.2025

24.3.2025

Fintepla

UCB Pharma S.A.

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

EU/1/20/1491

27.3.2025

24.3.2025

Rozlytrek

Roche Registration GmbH

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

EU/1/20/1460

25.3.2025

24.3.2025

Xromi

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

EU/1/19/1366

25.3.2025

24.3.2025

Zeposia

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1442

27.3.2025

28.3.2025

Abrysvo

Pfizer Europe MA EEIG

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

EU/1/23/1752

31.3.2025

28.3.2025

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

31.3.2025

28.3.2025

Daurismo

Pfizer Europe MA EEIG

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

EU/1/20/1451

31.3.2025

28.3.2025

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

1.4.2025

28.3.2025

Entyvio

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/14/923

31.3.2025

28.3.2025

Evrenzo

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/21/1574

2.4.2025

28.3.2025

Fluenz

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/24/1816

1.4.2025

28.3.2025

IXCHIQ

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/24/1828

31.3.2025

28.3.2025

Jaypirca

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/23/1738

31.3.2025

28.3.2025

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/15/1000

4.4.2025

28.3.2025

LOQTORZI

Topalliance Biosciences Europe Limited

Ground Floor, Two Dockland Central, Guild Street, I.f.s.c., Dublin 1, Co. Dublin, D01 K2C5, Ireland

EU/1/24/1853

31.3.2025

28.3.2025

Mvabea

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1445

31.3.2025

28.3.2025

Nivestim

Pfizer Europe MA EEIG

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

EU/1/10/631

1.4.2025

28.3.2025

PHELINUN

ADIENNE S.r.l.S.U.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/20/1487

2.4.2025

28.3.2025

Raxone

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/15/1020

2.4.2025

28.3.2025

Revlimid

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/391

1.4.2025

28.3.2025

Roclanda

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/20/1502

4.4.2025

28.3.2025

Supemtek Tetra

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1484

4.4.2025

28.3.2025

Taltz

Eli Lilly and Company (Ireland) Limited

Dunderrow, Kinsale, Co. Cork, Ireland

EU/1/15/1085

1.4.2025

28.3.2025

Talzenna

Pfizer Europe MA EEIG

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

EU/1/19/1377

31.3.2025

28.3.2025

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

31.3.2025

28.3.2025

Tevimbra

BeiGene Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/23/1758

2.4.2025

28.3.2025

Translarna

PTC Therapeutics International Limited

Unit 1, 52-55 Sir John Rogerson's Quay, Dublin 2, D02 NA07, Ireland

EU/1/13/902

31.3.2025

28.3.2025

Vyvgart

argenx BV

Industriepark-Zwijnaarde 7, 9052 Gent, België

EU/1/22/1674

31.3.2025

28.3.2025

Xeloda

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/163

1.4.2025

28.3.2025

Zabdeno

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1444

1.4.2025

28.3.2025

Zolgensma

Novartis Europharm Limited

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

EU/1/20/1443

1.4.2025

31.3.2025

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

3.4.2025

31.3.2025

FABHALTA

Novartis Europharm Limited

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

EU/1/24/1802

1.4.2025

31.3.2025

Fampridine Accord

Accord Healthcare S.L.U.

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

EU/1/20/1477

1.4.2025

31.3.2025

HETRONIFLY

Accord Healthcare S.L.U.

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

EU/1/24/1870

1.4.2025

31.3.2025

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

1.4.2025

31.3.2025

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

1.4.2025

31.3.2025

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

1.4.2025

31.3.2025

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

4.4.2025

— 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

6.3.2025

Riarify

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

7.3.2025

— 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

28.3.2025

Elmaro

Maropitant citrate monohydrate

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/25/337

Solution for injection

QA04AD90

1.4.2025

28.3.2025

Vectormune HVT-AIV

Avian influenza vaccine (live, recombinant)

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/25/335

Concentrate and solvent for suspension for injection

QI01AD

1.4.2025

— 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

28.3.2025

FORTEKOR PLUS

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/15/185

31.3.2025

28.3.2025

Increxxa

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/20/258

31.3.2025

28.3.2025

ProZinc

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

1.4.2025

28.3.2025

ReproCyc ParvoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/237

31.3.2025

28.3.2025

Sedadex

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/16/198

1.4.2025

28.3.2025

Sileo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

31.3.2025

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.