Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 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: 2024-03-27
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_202402197EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/2197


27.3.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 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/2024/2197)

—   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




9.2.2024


Casgevy


exagamglogene autotemcel







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/23/1787


Dispersion for infusion


B06AX


12.2.2024




9.2.2024


Mevlyq


eribulin







YES Pharmaceutical Development Services GmbH




Basler Strasse 7, 61352 Bad Homburg, Deutschland






EU/1/23/1789


Solution for injection


L01XX41


13.2.2024




9.2.2024


Skyclarys


omaveloxolone







Reata Ireland Limited




Block A, George's Quay Plaza, George's Quay, Dublin 2, D02 E440, Ireland






EU/1/23/1786


Capsule, hard


Pending


12.2.2024




16.2.2024


Ibuprofen Gen.Orph


ibuprofen







Gen.Orph




185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France






EU/1/23/1791


Solution for injection


C01EB16


21.2.2024




16.2.2024


Pomalidomide Viatris


pomalidomide







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/23/1785


Capsule, hard


L04AX06


19.2.2024




16.2.2024


Velsipity


etrasimod







Pfizer Europe MA EEIG




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






EU/1/23/1790


Film-coated tablet


L04AE05


19.2.2024




19.2.2024


Dabigatran etexilate Leon Farma


dabigatran etexilate







Laboratorios Leon Farma S.A.




C/ La Vallina s/n, Poligono Industrial Navatejera, 24193 Villaquilambre León, España






EU/1/23/1769


Capsule, hard


B01AE07


21.2.2024




22.2.2024


Holoclar


Ex vivo expanded autologous human corneal epithelial cells containing stem cells







Holostem S.r.l.




Via Glauco Gottardi 100, 41125 Modena, Italia






EU/1/14/987


Living tissue equivalent


S01XA19


23.2.2024




—   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




1.2.2024


Efavirenz Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/742


5.2.2024




1.2.2024


Hexacima







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/13/828


5.2.2024




1.2.2024


Hexyon







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/13/829


2.2.2024




1.2.2024


Inrebic







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1514


3.2.2024




1.2.2024


Mirvaso







Galderma International




Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France






EU/1/13/904


6.2.2024




1.2.2024


Mycamine







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/08/448


5.2.2024




1.2.2024


Simponi







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/09/546


6.2.2024




1.2.2024


Tafinlar







Novartis Europharm Limited




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






EU/1/13/865


2.2.2024




1.2.2024


Thiotepa Riemser







Esteve Pharmaceuticals GmbH




Hohenzollerndamm 150-151, 14199 Berlin, Deutschland






EU/1/21/1536


5.2.2024




1.2.2024


Tybost







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/872


5.2.2024




6.2.2024


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


7.2.2024




6.2.2024


Cegfila







Mundipharma Corporation (Ireland) Limited




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






EU/1/19/1409


7.2.2024




6.2.2024


Intuniv







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/15/1040


8.2.2024




6.2.2024


Keppra







UCB Pharma S.A.




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






EU/1/00/146


7.2.2024




6.2.2024


Nyxoid







Mundipharma Corporation (Ireland) Limited




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






EU/1/17/1238


7.2.2024




6.2.2024


Sixmo







L. Molteni & C. dei F.lli Alitti Società di .Esercizio .S.p.A




Strada Statale 67, Loc. Granatieri, 50018 Scandicci (Firenze), Italia






EU/1/19/1369


7.2.2024




6.2.2024


SomaKit TOC







Advanced Accelerator Applications




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






EU/1/16/1141


8.2.2024




8.2.2024


Clopidogrel Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/540


9.2.2024




8.2.2024


Coagadex







BPL Bioproducts Laboratory GmbH




Dornhofstrasse 34, 63263 Neu-Isenburg, Deutschland






EU/1/16/1087


12.2.2024




8.2.2024


Dynastat







Pfizer Europe MA EEIG




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






EU/1/02/209


9.2.2024




8.2.2024


QINLOCK







Deciphera Pharmaceuticals (Netherlands) B.V.




Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland






EU/1/21/1569


12.2.2024




8.2.2024


Scintimun







CIS bio international




Boîte Postale 32, 91192 Gif-sur-Yvette, France






EU/1/09/602


9.2.2024




8.2.2024


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


9.2.2024




8.2.2024


VidPrevtyn Beta







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/21/1580


9.2.2024




8.2.2024


Zypadhera







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/08/479


9.2.2024




8.2.2024


Zyprexa







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/96/022


9.2.2024




8.2.2024


Zyprexa Velotab







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/99/125


9.2.2024




9.2.2024


Clopidogrel Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/562


12.2.2024




9.2.2024


Doptelet







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/19/1373


14.2.2024




9.2.2024


DuoPlavin







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/10/619


12.2.2024




9.2.2024


Esperoct







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/19/1374


12.2.2024




9.2.2024


Protopic







Leo Pharma A/S




Industriparken 55, 2750 Ballerup, Danmark






EU/1/02/201


13.2.2024




9.2.2024


Rasilez







Noden Pharma DAC




D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland






EU/1/07/405


12.2.2024




9.2.2024


Translarna







PTC Therapeutics International Limited




5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland






EU/1/13/902


12.2.2024




9.2.2024


Viagra







Upjohn EESV




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






EU/1/98/077


15.2.2024




16.2.2024


Arixtra







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/02/206


19.2.2024




16.2.2024


Azopt







Novartis Europharm Limited




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






EU/1/00/129


19.2.2024




16.2.2024


Baqsimi







Amphastar France Pharmaceuticals




Usine Saint Charles, Eragny Sur Epte, 60590 France






EU/1/19/1406


20.2.2024




16.2.2024


Briviact







UCB Pharma S.A.




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






EU/1/15/1073


19.2.2024




16.2.2024


Bylvay







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/21/1566


19.2.2024




16.2.2024


Cayston







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/09/543


19.2.2024




16.2.2024


Entyvio







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/14/923


19.2.2024




16.2.2024


Evoltra







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/334


19.2.2024




16.2.2024


Fetcroja







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/20/1434


19.2.2024




16.2.2024


Hemlibra







Roche Registration GmbH




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






EU/1/18/1271


20.2.2024




16.2.2024


Herzuma







Celltrion Healthcare Hungary Kft.




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






EU/1/17/1257


19.2.2024




16.2.2024


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


19.2.2024




16.2.2024


IMJUDO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1713


19.2.2024




16.2.2024


Imraldi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1216


21.2.2024




16.2.2024


Jylamvo







Therakind (Europe) Limited




Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland






EU/1/17/1172


27.2.2024




16.2.2024


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/20/1468


19.2.2024




16.2.2024


Lupkynis







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/22/1678


20.2.2024




16.2.2024


LysaKare







Advanced Accelerator Applications




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






EU/1/19/1381


19.2.2024




16.2.2024


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


19.2.2024




16.2.2024


Pemazyre







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1535


21.2.2024




16.2.2024


Pregabalin Accord







Accord Healthcare S.L.U.




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






EU/1/15/1027


19.2.2024




16.2.2024


Sarclisa







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1435


19.2.2024




16.2.2024


Senshio







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/14/978


19.2.2024




16.2.2024


Stayveer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/832


19.2.2024




16.2.2024


Stocrin







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/111


19.2.2024




16.2.2024


Truvada







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/04/305


19.2.2024




16.2.2024


Viread







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/01/200


19.2.2024




16.2.2024


Vydura







Pfizer Europe MA EEIG




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






EU/1/22/1645


19.2.2024




16.2.2024


Xagrid







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/04/295


19.2.2024




22.2.2024


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


27.2.2024




22.2.2024


Docetaxel Accord







Accord Healthcare S.L.U.




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






EU/1/12/769


26.2.2024




22.2.2024


Ebvallo







Pierre Fabre Medicament




Les Cauquillous, 81500 Lavaur, France






EU/1/22/1700


26.2.2024




22.2.2024


Pravafenix







LABORATOIRES SMB SA




26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België






EU/1/11/679


23.2.2024




22.2.2024


Skytrofa







Ascendis Pharma Endocrinology Division A/S




Tuborg Boulevard 12, 2900 Hellerup, Danmark






EU/1/21/1607


23.2.2024




22.2.2024


Spectrila







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/15/1072


26.2.2024




22.2.2024


Strensiq







Alexion Europe SAS




103-105 rue Anatole France, 92300 Levallois-Perret, France






EU/1/15/1015


26.2.2024




22.2.2024


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


23.2.2024




23.2.2024


BLENREP







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/20/1474


29.2.2024




26.2.2024


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


28.2.2024




29.2.2024


Capecitabine medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/12/802


1.3.2024




29.2.2024


Posaconazole AHCL







Accord Healthcare S.L.U.




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






EU/1/19/1380


1.3.2024




29.2.2024


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


1.3.2024




29.2.2024


Tevagrastim







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/08/445


4.3.2024




29.2.2024


VidPrevtyn Beta







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/21/1580


1.3.2024




—   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




1.2.2024


Sustiva







Bristol-Myers Squibb Pharma EEIG




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






EU/1/99/110


3.2.2024




9.2.2024


Apealea







Inceptua AB




Gustavslundsv. 143, 16751 Bromma, Sverige






EU/1/18/1292


14.2.2024




—   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




1.2.2024


Solensia







Zoetis Belgium SA




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






EU/2/20/269


2.2.2024




1.2.2024


Solensia







Zoetis Belgium SA




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






EU/2/20/269


2.2.2024




1.2.2024


Zactran







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/08/082


6.2.2024




29.2.2024


Metacam







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/97/004


1.3.2024




29.2.2024


REXXOLIDE







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/20/263


6.3.2024




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.

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


ELI: http://data.europa.eu/eli/C/2024/2197/oj
ISSN 1977-091X (electronic edition)