Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2025 to 30 November 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)
Date: 2025-12-19
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_202506746EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/6746


19.12.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2025 to 30 November 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/2025/6746)

—   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




17.11.2025


Acvybra


Denosumab







Reddy Holding GmbH




Kobelweg 95, Augsburg 86156, Deutschland






EU/1/25/1983


Solution for injection


M05BX04


18.11.2025




17.11.2025


Degevma


denosumab







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/25/1985


Solution for injection


M05BX04


18.11.2025




17.11.2025


Denosumab Intas


denosumab







Intas Third Party Sales 2005, S.L.




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






EU/1/25/1993


Solution for injection


M05BX04


20.11.2025




17.11.2025


GOBIVAZ


golimumab







Advanz Pharma Limited




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






EU/1/25/1988


Solution for injection


L04AB06


19.11.2025




17.11.2025


Kefdensis


denosumab







STADA Arzneimittel AG




Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland






EU/1/25/1980


Solution for injection in a pre-filled syringe


M05BX04


18.11.2025




17.11.2025


Lynkuet


elinzanetant







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/25/1991


Capsule, soft


G02CX07


18.11.2025




17.11.2025


Ponlimsi


denosumab







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/25/1986


Solution for injection


M05BX04


18.11.2025




17.11.2025


Usgena


ustekinumab







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/25/1987


Solution for injection


L04AC05


18.11.2025




17.11.2025


Xbonzy


denosumab







Reddy Holding GmbH




Kobelweg 95, Augsburg 86156, Deutschland






EU/1/25/1982


Solution for injection


M05BX04


19.11.2025




17.11.2025


Zvogra


denosumab







STADA Arzneimittel AG




Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland






EU/1/25/1981


Solution for injection


M05BX04


18.11.2025




18.11.2025


Brinsupri


brensocatib







Insmed Netherlands B.V.




Stadsplateau 7, 3521 AZ Utrecht, Nederland






EU/1/25/1995


Film-coated tablet


Pending


19.11.2025




21.11.2025


Rivaroxaban Koanaa


Rivaroxaban







Koanaa Healthcare Spain, S.L.




Carretera Nacional 340, number 122, 4° 4a, 08960 Sant Just Desvern (Barcelona), España






EU/1/25/1994


Orodispersible film


B01AF01


25.11.2025




24.11.2025


Kyinsu


insulin icodec / semaglutide







Novo Nordisk A/S




Novo Alle 1, 2880 Bagsvaerd, Danmark






EU/1/25/1992


Solution for injection


A10AE57


27.11.2025




28.11.2025


Imaavy


nipocalimab







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/25/1989


Concentrate for solution for infusion


L04AL03


1.12.2025




—   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




21.11.2025


Atropine sulfate FGK







FGK Representative Service GmbH




Heimeranstraße 35, 80339 München, Deutschland






-


24.11.2025




—   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




3.11.2025


EU/3/23/2886







Kedrion S.p.A.




Castelvecchio Pascoli, Localita Ai Conti Snc, 55051 Barga, LU, Italia






EU/3/23/2886


5.11.2025




3.11.2025


Lutathera







Advanced Accelerator Applications




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






EU/1/17/1226


4.11.2025




3.11.2025


Norvir







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/96/016


4.11.2025




3.11.2025


Polivy







Roche Registration GmbH




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






EU/1/19/1388


4.11.2025




3.11.2025


RAYVOW







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/21/1587


20.11.2025




6.11.2025


Bildyos







SciencePharma Sp. z o.o.




Chełmska 30/34, 00-725 Warszawa, Polska






EU/1/25/1978


7.11.2025




6.11.2025


Bilprevda







SciencePharma Sp. z o.o.




Chełmska 30/34, 00-725 Warszawa, Polska






EU/1/25/1979


7.11.2025




6.11.2025


Dupixent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1229


7.11.2025




6.11.2025


Tryngolza







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/25/1969


7.11.2025




10.11.2025


AJOVY







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/19/1358


11.11.2025




10.11.2025


Bydureon







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/11/696


11.11.2025




10.11.2025


Constella







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/12/801


12.11.2025




10.11.2025


Eribulin Baxter







Baxter Holding B.V.




Kobaltweg 49, 3542 CE Utrecht, Nederland






EU/1/24/1819


14.11.2025




10.11.2025


Hirobriz Breezhaler







Novartis Europharm Limited




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






EU/1/09/594


12.11.2025




10.11.2025


Hulio







Biosimilar Collaborations Ireland Limited




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






EU/1/18/1319


12.11.2025




10.11.2025


Lumykras







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1603


11.11.2025




10.11.2025


Mepsevii







Ultragenyx Germany GmbH




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






EU/1/18/1301


11.11.2025




10.11.2025


Omlyclo







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1817


11.11.2025




10.11.2025


Pylclari







CURIUM PET France




Biopole Clermont-Limagne, 3 rue Marie Curie, 63360 Saint-Beauzire, France






EU/1/23/1746


12.11.2025




10.11.2025


QUVIVIQ







Idorsia Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland






EU/1/22/1638


17.11.2025




10.11.2025


Revolade







Novartis Europharm Limited




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






EU/1/10/612


11.11.2025




10.11.2025


Sapropterin Dipharma







Dipharma Arzneimittel GmbH




Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland






EU/1/21/1620


12.11.2025




10.11.2025


Tasigna







Novartis Europharm Limited




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






EU/1/07/422


11.11.2025




10.11.2025


Uplizna







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1602


11.11.2025




10.11.2025


Xofigo







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/873


11.11.2025




10.11.2025


Xultophy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/14/947


12.11.2025




10.11.2025


Zoledronic acid Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/771


13.11.2025




17.11.2025


Apretude







ViiV Healthcare BV




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






EU/1/23/1760


19.11.2025




17.11.2025


Byfavo







PAION Pharma GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/20/1505


18.11.2025




17.11.2025


CANCIDAS







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/01/196


18.11.2025




17.11.2025


Celldemic







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1806


18.11.2025




17.11.2025


EU/3/24/2973







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/3/24/2973


18.11.2025




17.11.2025


Fintepla







UCB Pharma S.A.




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






EU/1/20/1491


19.11.2025




17.11.2025


Heplisav B







Dynavax GmbH




Eichsfelder Strasse 11, D-40595 Düsseldorf, Deutschland






EU/1/20/1503


24.11.2025




17.11.2025


Jaypirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1738


18.11.2025




17.11.2025


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


18.11.2025




17.11.2025


Krazati







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1744


18.11.2025




17.11.2025


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27, Ireland






EU/1/19/1376


18.11.2025




17.11.2025


Lumigan







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/02/205


18.11.2025




17.11.2025


Lunsumio







Roche Registration GmbH




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






EU/1/22/1649


18.11.2025




17.11.2025


Lupkynis







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/22/1678


19.11.2025




17.11.2025


Lutetium (177Lu) chloride Billev







Billev Pharma ApS




Slotsmarken 10, 2970 Hørsholm, Danmark






EU/1/22/1680


24.11.2025




17.11.2025


Luxturna







Novartis Europharm Limited




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






EU/1/18/1331


18.11.2025




17.11.2025


Ogivri







Biosimilar Collaborations Ireland Limited




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






EU/1/18/1341


25.11.2025




17.11.2025


Ontozry







Angelini Pharma S.p.A




Viale Amelia 70, 00181 Rome, Italia






EU/1/21/1530


18.11.2025




17.11.2025


Praxbind







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/15/1056


19.11.2025




17.11.2025


Remsima







Celltrion Healthcare Hungary Kft.




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






EU/1/13/853


19.11.2025




17.11.2025


Scemblix







Novartis Europharm Limited




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






EU/1/22/1670


18.11.2025




17.11.2025


Symkevi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/18/1306


18.11.2025




17.11.2025


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


19.11.2025




17.11.2025


Vabysmo







Roche Registration GmbH




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






EU/1/22/1683


18.11.2025




17.11.2025


Xofluza







Roche Registration GmbH




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






EU/1/20/1500


18.11.2025




17.11.2025


Zejula







GlaxoSmithKline Trading Services Limited




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






EU/1/17/1235


18.11.2025




21.11.2025


Breyanzi







Bristol Myers Squibb Pharma EEIG




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






EU/1/22/1631


24.11.2025




21.11.2025


Cejemly







CStone Pharmaceuticals Ireland Limited




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






EU/1/24/1833


24.11.2025




21.11.2025


Cetrotide







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/99/100


24.11.2025




21.11.2025


Coagadex







Kedrion S.p.A.




Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca), Italia






EU/1/16/1087


24.11.2025




21.11.2025


CRYSVITA







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/17/1262


17.12.2025




21.11.2025


Delstrigo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1333


24.11.2025




21.11.2025


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


25.11.2025




21.11.2025


Enzalutamide Viatris







Viatris Limited




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






EU/1/24/1842


24.11.2025




21.11.2025


Erleada







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/18/1342


24.11.2025




21.11.2025


Fymskina







Formycon AG




Fraunhoferstraße 15, 82152 Martinsried/Planegg, Deutschland






EU/1/24/1862


25.11.2025




21.11.2025


Hyrimoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1286


24.11.2025




21.11.2025


Inbrija







Merz Therapeutics GmbH




Eckenheimer Landstraße 100, 60318 Frankfurt Am Main, Deutschland






EU/1/19/1390


24.11.2025




21.11.2025


Libmeldy







Orchard Therapeutics (Netherlands) B.V.




Bargelaan 200, 2333 CW Leiden, Nederland






EU/1/20/1493


24.11.2025




21.11.2025


Mevlyq







YES Pharmaceutical Development Services GmbH




Basler Strasse 7, 61352 Bad Homburg, Deutschland






EU/1/23/1789


24.11.2025




21.11.2025


Nevanac







Novartis Europharm Limited




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






EU/1/07/433


24.11.2025




21.11.2025


OXERVATE







Dompé farmaceutici S.p.A.




Via San Martino 12, 20122 Milano, Italia.






EU/1/17/1197


26.11.2025




21.11.2025


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


24.11.2025




21.11.2025


Sogroya







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1501


24.11.2025




21.11.2025


Ulunar Breezhaler







Novartis Europharm Limited




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






EU/1/14/917


24.11.2025




21.11.2025


Vizimpro







Pfizer Europe MA EEIG




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






EU/1/19/1354


24.11.2025




21.11.2025


Xoterna Breezhaler







Novartis Europharm Limited




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






EU/1/13/863


24.11.2025




26.11.2025


Braftovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1314


28.11.2025




26.11.2025


Byetta







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/06/362


27.11.2025




26.11.2025


Cosentyx







Novartis Europharm Limited




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






EU/1/14/980


27.11.2025




26.11.2025


Erbitux







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/04/281


27.11.2025




26.11.2025


EU/3/07/471







Kedrion S.p.A.




Castelvecchio Pascoli, Localita Ai Conti Snc, 55051 Barga, LU, Italia






EU/3/07/471


27.11.2025




26.11.2025


Eurartesim







Alfasigma S.p.A.




Via Ragazzi del '99, n.5, 40133 Bologna, Italia






EU/1/11/716


28.11.2025




26.11.2025


Galafold







Amicus Therapeutics Europe Limited




Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland






EU/1/15/1082


27.11.2025




26.11.2025


Granupas







Eurocept International B.V.




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/13/896


27.11.2025




26.11.2025


Kineret







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/02/203


28.11.2025




26.11.2025


Lucentis







Novartis Europharm Limited




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






EU/1/06/374


27.11.2025




26.11.2025


Mektovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1315


28.11.2025




26.11.2025


Mepact







Esteve Pharmaceuticals S.A.




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






EU/1/08/502


2.12.2025




26.11.2025


Mycamine







Sandoz Pharmaceuticals d.d.




Verovškova ulica 57, 1000 Ljubljana, Slovenija






EU/1/08/448


28.11.2025




26.11.2025


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


27.11.2025




26.11.2025


Posaconazole Accord







Accord Healthcare S.L.U.




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






EU/1/19/1379


27.11.2025




26.11.2025


Remicade







Janssen-Cilag International N.V.




Turnhoutseweg 30, 2340 Beerse, Antwerp, Belgie






EU/1/99/116


27.11.2025




26.11.2025


Sunitinib Accord







Accord Healthcare S.L.U.




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






EU/1/20/1511


27.11.2025




26.11.2025


Teriflunomide Accord







Accord Healthcare S.L.U.




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






EU/1/22/1693


27.11.2025




26.11.2025


Travatan







Novartis Europharm Limited




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






EU/1/01/199


27.11.2025




26.11.2025


Votubia







Novartis Europharm Limited




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






EU/1/11/710


27.11.2025




—   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




10.11.2025


Omidria







Rayner Surgical (Ireland) Limited




The Mill Enterprise Hub, Newtown Link Road, Drogheda, A92 CD3D, Co. Louth, Ireland






EU/1/15/1018


11.11.2025




17.11.2025


Bydureon







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/11/696


18.11.2025




21.11.2025


Telzir







ViiV Healthcare BV




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






EU/1/04/282


24.11.2025




26.11.2025


Byetta







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/06/362


27.11.2025




—   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




19.11.2025


Vaxxitek HVT+IBD+H5


avian influenza vaccine (live recombinant)







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/25/354


Concentrate and solvent for suspension for injection


QI01AD


19.11.2025




21.11.2025


Lenivia


izenivetmab







Zoetis Belgium




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






EU/2/25/355


Solution for injection in a vial


QN02BG93


26.11.2025




—   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




10.11.2025


Evanovo







Laboratorios Hipra, S.A.




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






EU/2/22/284


11.11.2025




17.11.2025


VAXXON ND CLONE







IZO S.r.l.




Via San Zeno 99/a 25124 Brescia (BS) Italia






EU/2/24/326


19.11.2025




21.11.2025


Emdocam







Emdoka




John Lijsenstraat 16, 2321 Hoogstraten, België






EU/2/11/128


24.11.2025




26.11.2025


DIVENCE Tetra







Laboratorios Hipra, S.A.




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






EU/2/24/310


27.11.2025




26.11.2025


Porcilis Porcoli Diluvac Forte







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/96/001


27.11.2025




26.11.2025


Recocam







Bimeda Animal Health Limited




2, 3 & 4 Airton Close,Tallaght, Dublin 24, Ireland






EU/2/11/133


27.11.2025




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/2025/6746/oj
ISSN 1977-091X (electronic edition)