Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2023 to 31 December 2023 (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: 2024-01-31
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_202400910EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/910


31.1.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2023 to 31 December 2023
         
(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/2024/910)

—   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




1.12.2023


Zilbrysq


zilucoplan







UCB Pharma S.A.




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






EU/1/23/1764


Solution for injection


L04A


4.12.2023




7.12.2023


ELREXFIO


elranatamab







Pfizer Europe MA EEIG




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






EU/1/23/1770


Solution for injection


Pending


8.12.2023




7.12.2023


Elucirem


gadopiclenol







Guerbet




15 rue des Vanesses, 93420, Villepinte, France






EU/1/23/1772


Solution for injection


V08CA


8.12.2023




7.12.2023


JEMPERLI


dostarlimab







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1538


Concentrate for solution for infusion


L01FF07


11.12.2023




7.12.2023


Veoza


fezolinetant







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/23/1771


Film-coated tablet


G02CX06


12.12.2023




7.12.2023


Vueway


gadopiclenol







Bracco Imaging SPA




Via Egidio Folli, 50 20134 Milano, Italia






EU/1/23/1773


Solution for injection


V08CA12


8.12.2023




13.12.2023


Dimethyl Fumarate Accord


dimethyl fumarate







Accord Healthcare S.L.U.




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






EU/1/22/1711


Gastro-resistant capsule, hard


L04AX07


13.12.2023




13.12.2023


Dimethyl fumarate Mylan


dimethyl fumarate







Mylan Ireland Limited




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






EU/1/22/1634


Gastro-resistant capsule, hard


L04AX07


13.12.2023




13.12.2023


Dimethyl fumarate Neuraxpharm


dimethyl fumarate







Laboratorios Lesvi, S.L.




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






EU/1/22/1637


Gastro-resistant capsule, hard


L04AX07


16.12.2023




13.12.2023


Dimethyl fumarate Polpharma


dimethyl fumarate







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19, 83-200 Starogard Gdański, Polska






EU/1/22/1635


Gastro-resistant capsule, hard


L04AX07


13.12.2023




13.12.2023


Dimethyl Fumarate Teva


dimethyl fumarate







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/22/1702


Gastro-resistant capsule, hard


L04AX07


15.12.2023




14.12.2023


AGAMREE


vamorolone







Santhera Pharmaceuticals (Deutschland) GmbH




Marie-Curie Straße 8, 79539 Lörrach, Deutschland






EU/1/23/1776


Oral suspension


 


15.12.2023




15.12.2023


Loargys


pegzilarginase







Immedica Pharma AB




SE-113 63, Stockholm, Sverige






EU/1/23/1774


Solution for injection or infusion


A16AB24


18.12.2023




22.12.2023


Rezzayo


Rezafungin







Mundipharma GmbH




De-Saint-Exupery-Strasse 10, 60549 Frankfurt Am Main, Deutschland






EU/1/23/1775


Powder for concentrate for solution for infusion


J02AX08


22.12.2023




—   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




1.12.2023


Bemfola







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/13/909


5.12.2023




1.12.2023


Beyfortus







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/22/1689


4.12.2023




1.12.2023


Clopidogrel Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/556


5.12.2023




1.12.2023


Dificlir







Tillotts Pharma GmbH




Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland






EU/1/11/733


4.12.2023




1.12.2023


Vaxelis







MCM Vaccine B.V.




Robert Boyleweg 4, 2333 CG Leiden, Nederland






EU/1/15/1079


4.12.2023




1.12.2023


Vizamyl







GE Healthcare AS




Nycoveien 1, 0485, Oslo, Norge






EU/1/14/941


6.12.2023




1.12.2023


VPRIV







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/10/646


6.12.2023




7.12.2023


Ammonaps







Immedica Pharma AB




Solnavagen 3 H, Stockholm, 113 63, Sverige






EU/1/99/120


8.12.2023




7.12.2023


Atazanavir Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/19/1353


14.12.2023




7.12.2023


Benepali







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/15/1074


12.12.2023




7.12.2023


Besremi







AOP Orphan Pharmaceuticals GmbH




Leopold-Ungar-Platz 2, 1190 Wien, Österreich






EU/1/18/1352


11.12.2023




7.12.2023


Byooviz







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/21/1572


12.12.2023




7.12.2023


CARVYKTI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1648


11.12.2023




7.12.2023


Erleada







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/18/1342


11.12.2023




7.12.2023


Fasturtec







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/00/170


8.12.2023




7.12.2023


Febuxostat Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/18/1347


14.12.2023




7.12.2023


Fluad Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/20/1433


13.12.2023




7.12.2023


Flucelvax Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/18/1326


14.12.2023




7.12.2023


Hemgenix







CSL Behring GmbH




D-35041 Marburg, Deutschland






EU/1/22/1715


15.12.2023




7.12.2023


Imatinib Accord







Accord Healthcare S.L.U.




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






EU/1/13/845


11.12.2023




7.12.2023


Intrarosa







Endoceutics S.A.




Rue Belliard 40, 1040 Bruxelles, Belgique/ Belliardstraat 40, 1040 Brussel, België






EU/1/17/1255


8.12.2023




7.12.2023


Jardiance







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


11.12.2023




7.12.2023


Lyrica







Upjohn EESV




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






EU/1/04/279


12.12.2023




7.12.2023


Neupro







UCB Pharma S.A.




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






EU/1/05/331


8.12.2023




7.12.2023


Omnitrope







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/06/332


11.12.2023




7.12.2023


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


11.12.2023




7.12.2023


Pregabalin Pfizer







Upjohn EESV




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






EU/1/14/916


12.12.2023




7.12.2023


Steglatro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1267


8.12.2023




7.12.2023


Striascan







CIS bio international




RN 306 — Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France






EU/1/19/1372


8.12.2023




7.12.2023


Sycrest







Organon N.V.




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/10/640


10.12.2023




7.12.2023


Symkevi







Vertex Pharmaceuticals (Ireland) Limited




Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland






EU/1/18/1306


8.12.2023




7.12.2023


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


12.12.2023




7.12.2023


Tecovirimat SIGA







SIGA Technologies Netherlands B.V.




Prinsenhil 29, Breda 4825 AX, Nederland






EU/1/21/1600


8.12.2023




7.12.2023


TECVAYLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1675


11.12.2023




7.12.2023


TOOKAD







Steba Biotech B.A.




14a Rue des Bains, L-1212, Luxembourg, Luxembourg






EU/1/17/1228


11.12.2023




7.12.2023


Vizimpro







Pfizer Europe MA EEIG




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






EU/1/19/1354


8.12.2023




7.12.2023


Vyepti







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/21/1599


11.12.2023




7.12.2023


Xevudy







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


11.12.2023




11.12.2023


AYVAKYT







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/20/1473


12.12.2023




11.12.2023


Brineura







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, Ireland






EU/1/17/1192


12.12.2023




11.12.2023


Erelzi







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1195


15.12.2023




11.12.2023


Evkeeza







Ultragenyx Germany GmbH




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






EU/1/21/1551


12.12.2023




11.12.2023


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


12.12.2023




11.12.2023


Mounjaro







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/22/1685


13.12.2023




11.12.2023


Moventig







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/14/962


12.12.2023




11.12.2023


Nepexto







Biosimilar Collaborations Ireland Limited




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






EU/1/20/1436


13.12.2023




11.12.2023


Pedea







Recordati Rare Diseases




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






EU/1/04/284


12.12.2023




11.12.2023


Pradaxa







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/08/442


12.12.2023




11.12.2023


Ventavis







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/03/255


12.12.2023




14.12.2023


AMGEVITA







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/16/1164


18.12.2023




14.12.2023


Enbrel







Pfizer Europe MA EEIG




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






EU/1/99/126


19.12.2023




14.12.2023


NexoBrid







MediWound Germany GmbH




Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland






EU/1/12/803


21.12.2023




14.12.2023


Pepaxti







Oncopeptides AB (publ)




Västra Trädgårdsgatan 15, 111 53 Stockholm, Sverige






EU/1/22/1669


15.12.2023




18.12.2023


Clopidogrel Taw Pharma







Taw Pharma (Ireland) Limited




104 Lower Baggot Street, Dublin 2, Ireland






EU/1/09/559


19.12.2023




18.12.2023


Clopidogrel Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/09/568


21.12.2023




19.12.2023


Amvuttra







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/22/1681


20.12.2023




19.12.2023


Ibandronic Acid Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/642


21.12.2023




19.12.2023


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland






EU/1/12/782


20.12.2023




19.12.2023


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


20.12.2023




19.12.2023


Tacforius







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/17/1244


8.1.2024




19.12.2023


Tevimbra







BeiGene Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland






EU/1/23/1758


22.12.2023




—   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




11.12.2023


Onbevzi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1499


13.12.2023




—   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




11.12.2023


Advocate







Elanco Animal Health GmbH




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






EU/2/03/039


12.12.2023




18.12.2023


Baycox Iron







Elanco Animal Health GmbH




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






EU/2/19/239


20.12.2023




19.12.2023


Credelio Plus







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/21/271


21.12.2023




19.12.2023


ERAVAC







Laboratorios Hipra, S.A.




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






EU/2/16/199


20.12.2023




19.12.2023


ERYSENG







Laboratorios Hipra, S.A.




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






EU/2/14/166


21.12.2023




19.12.2023


Evalon







Laboratorios Hipra, S.A.




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






EU/2/16/194


20.12.2023




19.12.2023


EVANT







Laboratorios Hipra, S.A.




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






EU/2/18/233


21.12.2023




19.12.2023


Hiprabovis IBR Marker Live







Laboratorios Hipra, S.A.




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






EU/2/10/114


21.12.2023




19.12.2023


Leucogen







Virbac




1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France






EU/2/09/096


20.12.2023




19.12.2023


Meloxoral







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/10/111


20.12.2023




19.12.2023


MHYOSPHERE PCV ID







Laboratorios Hipra, S.A.




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






EU/2/20/259


20.12.2023




19.12.2023


Nobivac LeuFel







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/17/217


20.12.2023




19.12.2023


Nobivac Myxo-RHD PLUS







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/19/244


21.12.2023




19.12.2023


RHINISENG







Laboratorios Hipra, S.A.




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






EU/2/10/109


22.12.2023




19.12.2023


STARTVAC







Laboratorios Hipra, S.A.




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






EU/2/08/092


22.12.2023




19.12.2023


Suvaxyn Circo







Zoetis Belgium




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






EU/2/17/223


21.12.2023




19.12.2023


Suvaxyn Circo + MH RTU







Zoetis Belgium




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






EU/2/15/190


21.12.2023




19.12.2023


UBAC







Laboratorios Hipra, S.A.




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






EU/2/18/227


21.12.2023




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.

(2)  
            OJ L 4, 7.1.2019, p. 43.


ELI: http://data.europa.eu/eli/C/2024/910/oj
ISSN 1977-091X (electronic edition)