Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2025 to 31 July 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: 2025-08-19
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_202504668EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/4668


19.8.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2025 to 31 July 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/2025/4668)







—



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




17.7.2025


Attrogy


Diflunisal







Purpose Pharma International AB




Grev Turegatan 13b 114 46 Stockholm, Sverige






EU/1/25/1929


Film-coated tablet


NO2BA11O


18.7.2025




17.7.2025


Aucatzyl


obecabtagene autoleucel







Autolus GmbH




Im Schwarzenbach 4, 79576 Weil am Rhein, Deutchland






EU/1/25/1951


Dispersion for infusion


L01XL12


18.7.2025




17.7.2025


Bomyntra


denosumab







Fresenius Kabi Deutschland GmbH




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






EU/1/25/1953


Solution for injection in a pre-filled syringe


M05BX04


18.7.2025




17.7.2025


Ezmekly


mirdametinib







SpringWorks Therapeutics Ireland Limited




Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland






EU/1/25/1950


Capsule, hard
Dispersible tablet


L01EE05


18.7.2025




17.7.2025


Rolcya


denosumab







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/25/1958


Solution for injection in a pre-filled syringe


M05BX04


24.7.2025




18.7.2025


Conexxence


denosumab







Fresenius Kabi Deutschland GmbH




Else-Kroener-Strasse 1, 61352 Bad Homburg von der Hoehe, Deutschland






EU/1/25/1954


Solution for injection


M05BX04


22.7.2025




18.7.2025


Emtricitabine/Tenofovir alafenamide Viatris


emtricitabine / tenofovir alafenamide







Viatris Limited




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






EU/1/25/1952


Film-coated tablet


J05AR17


23.7.2025




18.7.2025


Itovebi


inavolisib







Roche Registration GmbH




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






EU/1/25/1942


Film-coated tablet


Pending


22.7.2025




23.7.2025


BLENREP


belantamab mafodotin







GlaxoSmithKline Trading Services Limited




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






EU/1/25/1948


Powder for concentrate for solution for infusion


L01FX15


24.7.2025




28.7.2025


Maapliv


amino acids







Recordati Rare Diseases




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






EU/1/25/1955


Solution for infusion


B05BA01


29.7.2025




28.7.2025


RIULVY


Tegomil fumarate







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/25/1947


Gastro-resistant capsule, hard


L04AX10


7.8.2025














—



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




2.7.2025


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


3.7.2025




2.7.2025


MenQuadfi







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1483


3.7.2025




2.7.2025


Pemazyre







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1535


3.7.2025




7.7.2025


CARVYKTI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1648


8.7.2025




7.7.2025


Humira







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/03/256


8.7.2025




7.7.2025


Ozurdex







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/10/638


8.7.2025




7.7.2025


Rydapt







Novartis Europharm Limited




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






EU/1/17/1218


9.7.2025




7.7.2025


Temozolomide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/606


8.7.2025




9.7.2025


AMGEVITA







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/16/1164


10.7.2025




9.7.2025


CAMZYOS







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1716


15.7.2025




9.7.2025


Dovato







ViiV Healthcare BV




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






EU/1/19/1370


30.7.2025




9.7.2025


Fluad







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1878


14.7.2025




9.7.2025


Flucelvax







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1879


14.7.2025




9.7.2025


Fluenz







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1816


10.7.2025




9.7.2025


HALAVEN







Eisai GmbH




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






EU/1/11/678


10.7.2025




9.7.2025


Lamivudine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/566


10.7.2025




9.7.2025


Leflunomide ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/10/654


10.7.2025




9.7.2025


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


10.7.2025




9.7.2025


Remsima







Celltrion Healthcare Hungary Kft.




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






EU/1/13/853


16.7.2025




9.7.2025


Reyataz







Bristol-Myers Squibb Pharma EEIG




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






EU/1/03/267


15.7.2025




9.7.2025


Scemblix







Novartis Europharm Limited




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






EU/1/22/1670


10.7.2025




9.7.2025


Sugammadex Fresenius Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/22/1663


10.7.2025




9.7.2025


Tasmar







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/97/044


10.7.2025




9.7.2025


Tevimbra







BeOne Medicines Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/23/1758


10.7.2025




9.7.2025


Xtandi







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/13/846


10.7.2025




10.7.2025


Inhixa







Techdow Pharma Netherlands B.V.




Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland






EU/1/16/1132


16.7.2025




14.7.2025


Lenalidomide Krka







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1519


25.7.2025




14.7.2025


Sunlenca







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/22/1671


15.7.2025




14.7.2025


Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1127


16.7.2025




17.7.2025


Arsenic trioxide medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/20/1475


25.7.2025




17.7.2025


ASPAVELI







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/21/1595


7.8.2025




17.7.2025


Cresemba







Basilea Pharmaceutica Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/15/1036


29.7.2025




17.7.2025


Ebglyss







Almirall S.A.




Ronda General Mitre 151, 08022 Barcelona, España






EU/1/23/1765


18.7.2025




17.7.2025


Efient







SUBSTIPHARM




24 rue Erlanger, 75016 Paris, France






EU/1/08/503


18.7.2025




17.7.2025


Emtricitabine/Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1148


18.7.2025




17.7.2025


Hizentra







CSL Behring GmbH




Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland






EU/1/11/687


7.8.2025




17.7.2025


Incruse Ellipta







GlaxoSmithKline Trading Services Limited




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






EU/1/14/922


18.7.2025




17.7.2025


Jubbonti







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/24/1813


21.7.2025




17.7.2025


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/20/1468


18.7.2025




17.7.2025


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27, Ireland






EU/1/19/1376


18.7.2025




17.7.2025


Mysimba







Orexigen Therapeutics Ireland Limited




9-10 Fenian Street, Dublin 2, D02 RX24, Ireland






EU/1/14/988


21.7.2025




17.7.2025


NUBEQA







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/20/1432


25.7.2025




17.7.2025


Opdualag







Bristol Myers Squibb Pharma EEIG




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






EU/1/22/1679


22.7.2025




17.7.2025


Pramipexole Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/490


21.7.2025




17.7.2025


Prolia







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/10/618


18.7.2025




17.7.2025


Tepkinly







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/23/1759


18.7.2025




17.7.2025


Verzenios







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1307


18.7.2025




17.7.2025


Voriconazole Accord







Accord Healthcare S.L.U.




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






EU/1/13/835


18.7.2025




17.7.2025


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


19.7.2025




18.7.2025


Aclasta







Sandoz Pharmaceuticals d.d.




Verovškova ulica 57, 1000 Ljubljana, Slovenija






EU/1/05/308


24.7.2025




18.7.2025


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


24.7.2025




18.7.2025


Benlysta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/11/700


23.7.2025




18.7.2025


Darzalex







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/16/1101


23.7.2025




18.7.2025


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/17/1210


22.7.2025




18.7.2025


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


23.7.2025




18.7.2025


JERAYGO







Idorsia Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland






EU/1/24/1818


22.7.2025




18.7.2025


Laventair Ellipta







GlaxoSmithKline Trading Services Limited




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






EU/1/14/899


25.7.2025




18.7.2025


Multaq







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/09/591


24.7.2025




18.7.2025


Rezolsta







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/967


23.7.2025




18.7.2025


Sarclisa







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1435


22.7.2025




18.7.2025


Siklos







THERAVIA




16 Rue Montrosier, 92200 Neuilly-sur-Seine, France






EU/1/07/397


22.7.2025




18.7.2025


Supemtek Tetra







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1484


24.7.2025




18.7.2025


VEYVONDI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/18/1298


28.7.2025




18.7.2025


VITRAKVI







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/19/1385


22.7.2025




18.7.2025


Wezenla







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/24/1823


30.7.2025




23.7.2025


CABOMETYX







Ipsen Pharma




70 rue Balard, 75015 Paris, France






EU/1/16/1136


24.7.2025




23.7.2025


Chenodeoxycholic acid Leadiant







Leadiant GmbH




Liebherrstr. 22, 80538 Munich, Deutschland






EU/1/16/1110


24.7.2025




23.7.2025


Elocta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/15/1046


25.7.2025




23.7.2025


EXPAREL liposomal







Pacira Ireland Ltd




Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland






EU/1/20/1489


28.7.2025




23.7.2025


FRUZAQLA







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/24/1827


24.7.2025




23.7.2025


Ordspono







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27, Ireland






EU/1/24/1843


25.7.2025




23.7.2025


Repatha







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1016


24.7.2025




23.7.2025


Trulicity







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/956


24.7.2025




23.7.2025


Xofluza







Roche Registration GmbH




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






EU/1/20/1500


24.7.2025




23.7.2025


Zynlonta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/22/1695


24.7.2025




25.7.2025


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


29.7.2025




25.7.2025


Spikevax







MODERNA BIOTECH SPAIN, S.L.




C/ Julián Camarillo no 31, 28037 Madrid, España






EU/1/20/1507


29.7.2025




28.7.2025


Actraphane







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/229


30.7.2025




28.7.2025


Adcirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/08/476


6.8.2025




28.7.2025


Aerius







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/160


29.7.2025




28.7.2025


Anoro Ellipta







GlaxoSmithKline Trading Services Limited




12 River Walk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland






EU/1/14/898


30.7.2025




28.7.2025


Aranesp







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/01/185


30.7.2025




28.7.2025


AYVAKYT







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/20/1473


29.7.2025




28.7.2025


Azomyr







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/157


29.7.2025




28.7.2025


Calquence







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1479


29.7.2025




28.7.2025


Cinryze







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/11/688


30.7.2025




28.7.2025


Dzuveo







Laboratoire Aguettant




1 Rue Alexander Fleming, 69007 Lyon, France






EU/1/18/1284


29.7.2025




28.7.2025


Gardasil 9







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1007


29.7.2025




28.7.2025


Javlor







PIERRE FABRE MEDICAMENT




Les Cauquillous, 81500 Lavaur, France






EU/1/09/550


29.7.2025




28.7.2025


Oprymea







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/469


1.8.2025




28.7.2025


Phesgo







Roche Registration GmbH




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






EU/1/20/1497


30.7.2025




28.7.2025


Qalsody







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/23/1783


30.7.2025




28.7.2025


Revestive







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/12/787


29.7.2025




28.7.2025


Spinraza







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/17/1188


29.7.2025




28.7.2025


Vyxeos liposomal







Jazz Pharmaceuticals Ireland Ltd




5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland






EU/1/18/1308


29.7.2025




30.7.2025


ABILIFY MAINTENA







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/13/882


6.8.2025




30.7.2025


BiResp Spiromax







Teva Pharma B.V.




Swensweg 5, 2031GA Haarlem, Nederland






EU/1/14/921


7.8.2025




30.7.2025


DuoResp Spiromax







Teva Pharma B.V.




Swensweg 5, 2031GA Haarlem, Nederland






EU/1/14/920


7.8.2025




30.7.2025


Iqirvo







Ipsen Pharma




70 rue Balard, 75015 Paris, France






EU/1/24/1855


31.7.2025




30.7.2025


Leqvio







Novartis Europharm Limited




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






EU/1/20/1494


31.7.2025




30.7.2025


Neoclarityn







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/161


31.7.2025




30.7.2025


Neulasta







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/02/227


8.8.2025




30.7.2025


Orencia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/389


31.7.2025




30.7.2025


Rybrevant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


31.7.2025




30.7.2025


Wegovy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/21/1608


31.7.2025














—



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




14.7.2025


Fluenz Tetra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/887


15.7.2025














—



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




4.7.2025


Innovax-ND-IBD-ILT


Avian infectious laryngotracheitis, infectious bursal disease, Marek’s disease and Newcastle disease vaccine (live recombinant)







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/25/347


Concentrate and solvent for suspension for injection


QI01AD20


7.7.2025




24.7.2025


Numelvi


atinvicitinib







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/25/351


Tablet


QD11AH93


31.7.2025




24.7.2025


Zenrelia


Ilunocitinib







Elanco GmbH




Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Deutschland






EU/2/25/349


Film-coated tablet


QD11AH92


25.7.2025




30.7.2025


BRAVECTO CombiUNO


fluralaner / milbemycin oxime







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/25/350


Chewable tablet


QP54AB51


4.8.2025














—



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




4.7.2025


Reconcile







FORTE Healthcare Ltd




Cougar Lane, Naul, Co. Dublin, Ireland






EU/2/08/080


16.7.2025




4.7.2025


Sevohale







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/16/196


7.7.2025




10.7.2025


BLUEVAC BTV







CZ Vaccines S.A.U.




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






EU/2/11/122


23.7.2025




10.7.2025


DogStem







EquiCord S.L.




103-D Loeches, Polígono Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España






EU/2/22/285


11.7.2025




24.7.2025


Bravecto







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/158


28.7.2025




24.7.2025


Daxocox







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/21/270


25.7.2025




24.7.2025


Ecoporc SHIGA







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/13/149


30.7.2025




24.7.2025


Masivet







AB Science S.A.




3 avenue George V, 75008 Paris, France






EU/2/08/087


29.7.2025




24.7.2025


Meloxidyl







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/06/070


28.7.2025




24.7.2025


Mometamax Ultra







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/22/289


28.7.2025




24.7.2025


NexGard







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/13/159


28.7.2025




24.7.2025


NEXGARD SPECTRA







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/14/177


28.7.2025




30.7.2025


Imoxat







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/21/280


1.8.2025




30.7.2025


Innovax-ND-H5







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/24/315


31.7.2025




30.7.2025


Reconcile







FORTE Healthcare Ltd




Cougar Lane, Naul, Co. Dublin, Ireland






EU/2/08/080


31.7.2025














—



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




30.7.2025


Felisecto Plus







Zoetis Belgium SA




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






EU/2/19/238


6.8.2025




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/2025/4668/oj
ISSN 1977-091X (electronic edition)