Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2024 to 31 August 2024 (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: 2024-09-30
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_202405667EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/5667


30.9.2024








Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2024 to 31 August 2024
               




(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/2024/5667)







—



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




1.8.2024


ADZYNMA


rADAMTS13







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/24/1837


Powder and solvent for solution for injection


B01AD13


2.8.2024




1.8.2024


GalliaPharm


germanium (68Ge) chloride / gallium (68Ga) chloride







Eckert & Ziegler Radiopharma GmbH




Robert-Rössle-Straße 10, 13125 Berlin, Deutschland






EU/1/24/1836


Radionuclide generator.


V09X


2.8.2024




22.8.2024


AKANTIOR


polihexanide







SIFI S.p.A.




Via Ercole Patti 36, 95025 Aci Sant’Antonio (CT), Italia






EU/1/24/1840


Eye drops, solution


S01AX24


23.8.2024




22.8.2024


Balversa


erdafitinib







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/24/1841


Film-coated tablet


L01EN01


23.8.2024




22.8.2024


Enzalutamide Viatris


enzalutamide







Viatris Limited




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






EU/1/24/1842


Film-coated tablet


L02BB04


23.8.2024




22.8.2024


EURneffy


Epinephrine







ARS Pharmaceuticals IRL, Limited




The Black Church, Saint Mary’s Place North, Dublin 7, Co. Dublin, D07 P4AX, Ireland






EU/1/24/1846


Nasal spray, solution


C01CA24


23.8.2024




22.8.2024


mRESVIA


Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation







MODERNA BIOTECH SPAIN, S.L.




C/ Julián Camarillo no 31, 28037 Madrid, España






EU/1/24/1849


dispersion for injection


J07BX05


23.8.2024




22.8.2024


Nilotinib Accord


nilotinib







Accord Healthcare S.L.U.




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






EU/1/24/1845


Capsule, hard


L01EA03


23.8.2024




22.8.2024


Ordspono


odronextamab







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27, Ireland






EU/1/24/1843


Solution for infusion


Pending


23.8.2024




22.8.2024


Piasky


crovalimab







Roche Registration GmbH




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






EU/1/24/1848


Solution for injection or infusion


L04AJ07


26.8.2024




22.8.2024


STEQEYMA


ustekinumab







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1844


Concentrate for solution for infusion
Solution for injection in a pre-filled syringe


L04AC05


23.8.2024




22.8.2024


Tauvid


Flortaucipir (18F)







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/24/1799


Solution for injection


V09AX07


26.8.2024




22.8.2024


Winrevair


sotatercept







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/24/1850


Powder and solvent for solution for injection
Powder for solution for injection


C02KX06


27.8.2024














—



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




1.8.2024


Arava







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/99/118


6.8.2024




1.8.2024


Beyfortus







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/22/1689


2.8.2024




1.8.2024


Bimzelx







UCB Pharma S.A.




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






EU/1/21/1575


5.8.2024




1.8.2024


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


2.8.2024




1.8.2024


Infanrix hexa







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/00/152


6.8.2024




1.8.2024


Noxafil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/320


2.8.2024




1.8.2024


Reagila







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/17/1209


15.8.2024




1.8.2024


Rybelsus







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1430


5.8.2024




1.8.2024


Vosevi







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/17/1223


6.8.2024




5.8.2024


ADVATE







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/03/271


6.8.2024




5.8.2024


CAMZYOS







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1716


6.8.2024




5.8.2024


Dabigatran Etexilate Accord







Accord Healthcare S.L.U.




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






EU/1/22/1665


12.8.2024




5.8.2024


Dapagliflozin Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/23/1721


6.8.2024




5.8.2024


Filsuvez







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/22/1652


8.8.2024




5.8.2024


Fotivda







Recordati Netherlands B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/17/1215


13.8.2024




5.8.2024


Lojuxta







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/13/851


8.8.2024




5.8.2024


Pegasys







pharmaand GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/02/221


6.8.2024




5.8.2024


Skyclarys







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/23/1786


6.8.2024




5.8.2024


Vyndaqel







Pfizer Europe MA EEIG




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






EU/1/11/717


6.8.2024




9.8.2024


Actos







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/00/150


21.8.2024




9.8.2024


Forxiga







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/795


12.8.2024




9.8.2024


Xarelto







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/08/472


12.8.2024




12.8.2024


Hefiya







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1287


13.8.2024




12.8.2024


Lynparza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/959


13.8.2024




12.8.2024


TRIXEO AEROSPHERE







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1498


13.8.2024




12.8.2024


Zypadhera







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/08/479


14.8.2024




16.8.2024


Abrysvo







Pfizer Europe MA EEIG




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






EU/1/23/1752


19.8.2024




16.8.2024


Competact







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/06/354


9.9.2024




16.8.2024


Jaypirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1738


19.8.2024




16.8.2024


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


19.8.2024




16.8.2024


Roctavian







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/22/1668


22.8.2024




16.8.2024


Spinraza







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/17/1188


19.8.2024




16.8.2024


Tepkinly







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/23/1759


19.8.2024




22.8.2024


Baqsimi







Amphastar France Pharmaceuticals




Usine Saint Charles, Eragny Sur Epte, 60590 France






EU/1/19/1406


23.8.2024




22.8.2024


Betmiga







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/12/809


27.8.2024




22.8.2024


Cegfila







Mundipharma Corporation (Ireland) Limited




United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland






EU/1/19/1409


23.8.2024




22.8.2024


Clopidogrel/Acetylsalicylic acid Viatris







Viatris Limited




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






EU/1/19/1395


23.8.2024




22.8.2024


Copiktra







Secura Bio Limited




32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland






EU/1/21/1542


29.8.2024




22.8.2024


Cresemba







Basilea Pharmaceutica Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/15/1036


23.8.2024




22.8.2024


Evenity







UCB Pharma S.A.




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






EU/1/19/1411


26.8.2024




22.8.2024


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


23.8.2024




22.8.2024


Instanyl







Istituto Gentili S.r.l.




Via San Giuseppe Cottolengo 15, 20143 Milano, Italia






EU/1/09/531


27.8.2024




22.8.2024


Jylamvo







Oresund Pharma ApS




Orient Plads 1, 2150 Nordhavn, Danmark






EU/1/17/1172


23.8.2024




22.8.2024


Jyseleca







Alfasigma S.p.A.




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






EU/1/20/1480


28.8.2024




22.8.2024


Mounjaro







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/22/1685


26.8.2024




22.8.2024


Quofenix







A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.




Via Sette Santi 3, 50131 Florence, Italia






EU/1/19/1393


27.8.2024




22.8.2024


Rybrevant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


23.8.2024




22.8.2024


Savene







CNX Therapeutics Ireland Limited




5th Floor Rear, Connaught House, 1 Burlington Road, Dublin 4, Ireland






EU/1/06/350


23.8.2024




22.8.2024


Signifor







Recordati Rare Diseases




Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800  Puteaux, France






EU/1/12/753


26.8.2024




22.8.2024


Spravato







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/19/1410


23.8.2024




22.8.2024


Suliqua







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/16/1157


23.8.2024




22.8.2024


XALKORI







Pfizer Europe MA EEIG




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






EU/1/12/793


23.8.2024




26.8.2024


Arexvy







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/23/1740


27.8.2024




26.8.2024


Padcev







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1615


27.8.2024




26.8.2024


Slenyto







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/18/1318


28.8.2024




26.8.2024


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


27.8.2024




29.8.2024


Abiraterone Accord







Accord Healthcare S.L.U.




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






EU/1/20/1512


30.8.2024




29.8.2024


Braftovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1314


3.9.2024




29.8.2024


Ilaris







Novartis Europharm Limited




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






EU/1/09/564


30.8.2024




29.8.2024


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


30.8.2024




29.8.2024


Mektovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1315


3.9.2024




29.8.2024


Opfolda







Amicus Therapeutics Europe Limited




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






EU/1/23/1737


30.8.2024




29.8.2024


Rixathon







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1185


30.8.2024




29.8.2024


Vyvgart







argenx BV




Industriepark-Zwijnaarde 7, 9052 Gent, België






EU/1/22/1674


30.8.2024




29.8.2024


Xigduo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/900


30.8.2024




30.8.2024


ADYNOVI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/17/1247


3.9.2024




30.8.2024


ASPAVELI







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/21/1595


2.9.2024




30.8.2024


Nordimet







Nordic Group B.V.




Siriusdreef 41, 2132 WT Hoofddorp, Nederland






EU/1/16/1124


2.9.2024




30.8.2024


Riltrava Aerosphere







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1604


2.9.2024














—



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




2.8.2024


NYXTHRACIS







SFL Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/20/1485


5.8.2024














—



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




9.8.2024


DIVENCE IBR Marker Live


Bovine herpesvirus type 1 (live) vaccine







Laboratorios Hipra, S.A.




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






EU/2/24/318


lyophilisate and solvent for emulsion for injection


QI02AD01


20.8.2024




30.8.2024


Cevac Salmune ETI K



Salmonella enterica, subsp. enterica, serovar Enteritidis; Salmonella enterica, subsp. enterica, serovar Typhimurium; and Salmonella enterica, subsp. enterica, serovar Infantis vaccine (inactivated) for chickens







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/24/320


Suspension for injection


QI01AB01


2.9.2024




30.8.2024


Porcilis PCV M Hyo ID


Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/24/319


Emulsion for injection


QI09AL08


2.9.2024














—



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




2.8.2024


AdTab







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/22/288


6.8.2024




2.8.2024


Credelio







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/206


6.8.2024




2.8.2024


Daxocox







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/21/270


5.8.2024




2.8.2024


Mirataz







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/19/247


5.8.2024




2.8.2024


PREVEXXION RN+HVT







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/23/302


6.8.2024




2.8.2024


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


6.8.2024




5.8.2024


Neptra







Elanco Animal Health GmbH




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






EU/2/19/246


6.8.2024




5.8.2024


Stronghold Plus







Zoetis Belgium




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






EU/2/16/204


9.8.2024




5.8.2024


Vaxxitek HVT + IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/02/032


6.8.2024




9.8.2024


PREVEXXION RN







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/254


12.8.2024




9.8.2024


Suvaxyn PRRS MLV







Zoetis Belgium




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






EU/2/17/215


12.8.2024




20.8.2024


CircoMax







Zoetis Belgium




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






EU/2/21/281


22.8.2024




20.8.2024


Exzolt







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/212


21.8.2024




22.8.2024


Aivlosin







ECO Animal Health Europe Limited




6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland






EU/2/04/044


23.8.2024




22.8.2024


FATROVAX RHD







FATRO S.p.A.




Via Emilia 285, 40064 Ozzano dell’Emilia (BO), ITALIA






EU/2/21/275


23.8.2024




30.8.2024


Clomicalm







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/98/007


2.9.2024




30.8.2024


Vectormune ND







CEVA-Phylaxia Co. Ltd




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/15/188


5.9.2024








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/2024/5667/oj
ISSN 1977-091X (electronic edition)