Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2025 to 28 February 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: 2025-03-31
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_202501825EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/1825


31.3.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2025 to 28 February 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/2025/1825)

—   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




3.2.2025


HETRONIFLY


serplulimab







Henlius Europe GmbH




Sternstraße 67, 40479 Düsseldorf, Deutschland






EU/1/24/1870


Concentrate for solution for infusion


L01FF12


6.2.2025




10.2.2025


ANDEMBRY


garadacimab







CSL Behring GmbH




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






EU/1/24/1885


Solution for injection


B06AC07


12.2.2025




10.2.2025


BEYONTTRA


acoramidis







BridgeBio Europe B.V.




Weerdestein 97, 1083 GG Amsterdam, Noord-Holland, Nederland






EU/1/24/1906


Film-coated tablet


C01EB25


11.2.2025




10.2.2025


Korjuny


catumaxomab







Lindis Biotech GmbH




Zeppelinstraße 4, 82178 Puchheim, Deutschland






EU/1/24/1826


Concentrate for solution for infusion


L01FX03


12.2.2025




12.2.2025


Emcitate


Tiratricol







Rare Thyroid Therapeutics International AB




Klara Norra Kyrkogata 26, 111 22 Stockholm, Sverige






EU/1/24/1897


Dispersible tablet


H03AA04


17.2.2025




12.2.2025


Eydenzelt


Aflibercept







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1895


Solution for injection


S01LA05


18.2.2025




12.2.2025


Kostaive


zapomeran







Arcturus Therapeutics Europe B.V.




Claude Debussylaan 10, 1082 MD Amsterdam, Nederland






EU/1/24/1873


Powder for dispersion for injection


J07BX03


13.2.2025




12.2.2025


Nemluvio


Nemolizumab







Galderma International




La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France






EU/1/24/1901


Powder and solvent for solution for injection


D11AH12


13.2.2025




12.2.2025


Obodence


Denosumab







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1890


Solution for injection in a pre-filled syringe


M05BX04


13.2.2025




12.2.2025


WELIREG


belzutifan







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/24/1893


Film-coated tablet


L01XX74


14.2.2025




12.2.2025


Xbryk


denosumab







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1889


Solution for injection


M05BX04


13.2.2025




12.2.2025


Zefylti


Filgrastim







CuraTeQ Biologics s.r.o




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






EU/1/24/1899


Solution for injection or infusion


L03AA02


14.2.2025




14.2.2025


Avtozma


tocilizumab







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1896


Concentrate for solution for infusion


L04AC07


24.2.2025




14.2.2025


Osenvelt


Denosumab







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1904


Solution for injection


M05BX04


17.2.2025




14.2.2025


Stoboclo


Denosumab







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1905


Solution for injection


M05BX04


21.2.2025




14.2.2025


Yesintek


ustekinumab







Biosimilar Collaborations Ireland Limited




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






EU/1/24/1892


Concentrate for solution for infusion
Solution for injection


L04AC05


17.2.2025




20.2.2025


Seladelpar Gilead


seladelpar







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/24/1898


Capsule, hard


A05AX07


21.2.2025




26.2.2025


Paxneury


guanfacine







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/24/1908


Prolonged-release tablet


C02AC02


4.3.2025




28.2.2025


Tuzulby


Methylphenidate hydrochloride







Neuraxpharm Pharmaceuticals S.L.




Avinguda De Barcelona 69, Poligono Industrialde La Fuensanta, 08970 Sant Joan Despi, España






EU/1/24/1907


Prolonged-release chewable tablet


N06BA04


3.3.2025




28.2.2025


VIMKUNYA


Chikungunya vaccine (recombinant, adsorbed)







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/25/1916


Suspension for injection


Pending


28.2.2025




—   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




3.2.2025


Ambrisentan Viatris







Viatris Limited




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






EU/1/19/1368


5.2.2025




3.2.2025


Arsenic trioxide Mylan







Mylan Ireland Limited




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






EU/1/20/1427


5.2.2025




3.2.2025


Brintellix







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/13/891


4.2.2025




3.2.2025


Catiolanze







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/23/1763


5.2.2025




3.2.2025


Ervebo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1392


4.2.2025




3.2.2025


Eucreas







Novartis Europharm Limited




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






EU/1/07/425


4.2.2025




3.2.2025


EURneffy


ALK-Abelló A/S, Bøge Allé 6-8, 2970 Hørsholm, Danmark


EU/1/24/1846


7.2.2025




3.2.2025


Icandra







Novartis Europharm Limited




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






EU/1/08/484


4.2.2025




3.2.2025


Kesimpta







Novartis Europharm Limited




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






EU/1/21/1532


6.2.2025




3.2.2025


Kinzalkomb







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/214


4.2.2025




3.2.2025


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/02/213


5.2.2025




3.2.2025


Pregabalin Pfizer







Upjohn EESV




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






EU/1/14/916


4.2.2025




3.2.2025


Roclanda







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/20/1502


5.2.2025




3.2.2025


Ryeqo







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1565


6.2.2025




3.2.2025


Zeffix







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/99/114


5.2.2025




3.2.2025


Zomarist







Novartis Europharm Limited




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






EU/1/08/483


4.2.2025




7.2.2025


Duloxetine Viatris







Viatris Limited




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






EU/1/15/1010


10.2.2025




7.2.2025


Piqray







Novartis Europharm Limited




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






EU/1/20/1455


10.2.2025




7.2.2025


Synjardy







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/15/1003


5.3.2025




7.2.2025


Veoza







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/23/1771


13.2.2025




10.2.2025


Ambrisentan Viatris







Viatris Limited




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






EU/1/19/1368


12.2.2025




10.2.2025


GoResp Digihaler







Teva Pharma B.V.




Swensweg 5, 2031GA Haarlem, Nederland






EU/1/19/1403


14.2.2025




10.2.2025


Jardiance







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


17.2.2025




10.2.2025


Ryzodeg







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/12/806


12.2.2025




10.2.2025


Semglee







Biosimilar Collaborations Ireland Limited




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






EU/1/18/1270


11.2.2025




10.2.2025


Teysuno







Nordic Group B.V.




Siriusdreef 41, 2132 WT Hoofddorp, Nederland






EU/1/11/669


13.2.2025




10.2.2025


Translarna







PTC Therapeutics International Limited




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






EU/1/13/902


11.2.2025




10.2.2025


Tresiba







Novo Nordisk A/S




Novo Alle 1, 2880 Bagsvaerd, Danmark






EU/1/12/807


11.2.2025




10.2.2025


Xaluprine







Nova Laboratories Ireland Limited




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






EU/1/11/727


11.2.2025




12.2.2025


Advagraf







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/07/387


13.2.2025




12.2.2025


Bemrist Breezhaler







Novartis Europharm Limited




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






EU/1/20/1441


17.2.2025




12.2.2025


Casgevy







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/23/1787


17.2.2025




12.2.2025


Envarsus







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/935


13.2.2025




12.2.2025


Filspari







Vifor France




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






EU/1/23/1788


13.2.2025




12.2.2025


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


13.2.2025




12.2.2025


Nepexto







Biosimilar Collaborations Ireland Limited




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






EU/1/20/1436


14.2.2025




12.2.2025


Ofev







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/979


14.2.2025




12.2.2025


Omvoh







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1736


13.2.2025




12.2.2025


Upstaza







PTC Therapeutics International Limited




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






EU/1/22/1653


14.2.2025




12.2.2025


Zimbus Breezhaler







Novartis Europharm Limited




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






EU/1/20/1440


17.2.2025




14.2.2025


Arexvy







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/23/1740


18.2.2025




14.2.2025


Atectura Breezhaler







Novartis Europharm Limited




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






EU/1/20/1439


17.2.2025




14.2.2025


Avamys







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/07/434


20.2.2025




14.2.2025


Enerzair Breezhaler







Novartis Europharm Limited




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






EU/1/20/1438


17.2.2025




14.2.2025


IMJUDO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1713


17.2.2025




14.2.2025


Modigraf







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/09/523


17.2.2025




14.2.2025


Mounjaro







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/22/1685


27.2.2025




14.2.2025


Reblozyl







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1452


18.2.2025




14.2.2025


Tepadina







ADIENNE S.r.l.S.U.




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






EU/1/10/622


17.2.2025




14.2.2025


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


17.2.2025




14.2.2025


Zoely







Theramex Ireland Limited




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






EU/1/11/690


17.2.2025




20.2.2025


Bretaris Genuair







Covis Pharma Europe B.V.




Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland






EU/1/12/781


24.2.2025




20.2.2025


Brimica Genuair







Covis Pharma Europe B.V.




Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland






EU/1/14/963


24.2.2025




20.2.2025


Cotellic







Roche Registration GmbH




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






EU/1/15/1048


24.2.2025




20.2.2025


Duaklir Genuair







Covis Pharma Europe B.V.




Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland






EU/1/14/964


24.2.2025




20.2.2025


Eklira Genuair







Covis Pharma Europe B.V.




Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland






EU/1/12/778


24.2.2025




20.2.2025


Hemlibra







Roche Registration GmbH




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






EU/1/18/1271


21.2.2025




20.2.2025


Mekinist







Novartis Europharm Limited




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






EU/1/14/931


21.2.2025




20.2.2025


Sarclisa







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1435


24.2.2025




20.2.2025


Sugammadex Piramal







Piramal Critical Care B.V.




Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland






EU/1/23/1739


24.2.2025




20.2.2025


Uzpruvo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/23/1784


24.2.2025




20.2.2025


Xevudy







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


24.2.2025




21.2.2025


Dynastat







Pfizer Europe MA EEIG




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






EU/1/02/209


24.2.2025




21.2.2025


Finlee







Novartis Europharm Limited




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






EU/1/23/1767


24.2.2025




21.2.2025


Nimenrix







Pfizer Europe MA EEIG




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






EU/1/12/767


24.2.2025




21.2.2025


Zavesca







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/238


24.2.2025




26.2.2025


Aripiprazole Mylan Pharma







Mylan Pharmaceuticals Limited




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






EU/1/15/1005


27.2.2025




26.2.2025


Heplisav B







Dynavax GmbH




Eichsfelder Strasse 11, D-40595 Düsseldorf, Deutschland






EU/1/20/1503


28.2.2025




26.2.2025


Inrebic







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1514


27.2.2025




26.2.2025


Lydisilka







Estetra SRL




Rue Saint Georges 5-7, 4000 Liège, Belgique






EU/1/21/1548


27.2.2025




26.2.2025


Natpar







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/15/1078


27.2.2025




26.2.2025


Peyona







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/09/528


28.2.2025




26.2.2025


Pregabalin Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1021


28.2.2025




26.2.2025


Prolia







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/10/618


2.3.2025




26.2.2025


Stayveer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/832


27.2.2025




26.2.2025


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


27.2.2025




26.2.2025


Ucedane







Eurocept International B.V.




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/17/1202


5.3.2025




26.2.2025


Volibris







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/08/451


27.2.2025




26.2.2025


Voraxaze







SERB SAS




40 Avenue George V, 75008 Paris, France






EU/1/21/1586


28.2.2025




28.2.2025


Bevespi Aerosphere







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1339


3.3.2025




28.2.2025


Doptelet







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/19/1373


3.3.2025




28.2.2025


Drovelis







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1547


5.3.2025




28.2.2025


Kymriah







Novartis Europharm Limited




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






EU/1/18/1297


4.3.2025




28.2.2025


Litfulo







Pfizer Europe MA EEIG




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






EU/1/23/1755


3.3.2025




28.2.2025


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


3.3.2025




28.2.2025


Ronapreve







Roche Registration GmbH




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






EU/1/21/1601


3.3.2025




28.2.2025


Sivextro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/991


3.3.2025




28.2.2025


Truqap







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1820


3.3.2025




28.2.2025


YERVOY







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


3.3.2025




28.2.2025


Zelboraf







Roche Registration GmbH




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






EU/1/12/751


3.3.2025




—   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




26.2.2025


Mycapssa







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/22/1690


3.3.2025




—   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




3.2.2025


TOLFENAMIC ACID VMD


Tolfenamic acid







V.M.D.




Hoge Mauw 900, 2370 Arendonk, Belgïe






EU/2/24/329


Solution for injection


QM01AG02


4.2.2025




20.2.2025


BLUEVAC-3


Bluetongue virus vaccine (inactivated)







CZ Vaccines S.A.U.




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






EU/2/24/331


Suspension for injection


QI04AA02


21.2.2025




20.2.2025


Syvazul BTV 3


bluetongue virus vaccine (inactivated)







Laboratorios Syva S.A




C/Marqués de la Ensenada16, 28004 Madrid, España






EU/2/24/332


Suspension for injection


QI04AA02


21.2.2025




27.2.2025


Nobilis Multriva REOm


Avian reovirus, strain ARV-1, Inactivated, Avian reovirus, strain ARV-4, Inactivated







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/24/333


Emulsion for injection


QI01AA04


3.3.2025




—   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




3.2.2025


Profender







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/05/054


4.2.2025




14.2.2025


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


18.2.2025




20.2.2025


PREVEXXION RN







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/254


21.2.2025




20.2.2025


PREVEXXION RN+HVT







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/23/302


21.2.2025




20.2.2025


Vaxxitek HVT + IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/02/032


21.2.2025




27.2.2025


Newflend ND H9







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/23/296


3.3.2025




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.


ELI: http://data.europa.eu/eli/C/2025/1825/oj
ISSN 1977-091X (electronic edition)