Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2024 to 30 April 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: 2024-05-31
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_202403355EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/3355


31.5.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2024 to 30 April 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/2024/3355)

—   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




19.4.2024


Apremilast Accord


apremilast







Accord Healthcare S.L.U.




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






EU/1/24/1796


Film-coated tablet


L04AA32


23.4.2024




19.4.2024


CARVYKTI


ciltacabtagene autoleucel







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1648


Dispersion for infusion


L01XL05


22.4.2024




19.4.2024


Celldemic


Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1806


Suspension for injection in pre-filled syringe (injection).


J07BB02


22.4.2024




19.4.2024


Filspari


Sparsentan







Vifor France S.A.




Tour Franklin La Defense 8, 100-101 Terrasse Boieldieu, 92042 Paris La Defense Cedex, France






EU/1/23/1788


Film-coated tablet


C09XX01


23.4.2024




19.4.2024


Incellipan


Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1807


Suspension for injection


J07BB02


23.4.2024




19.4.2024


Nintedanib Accord


nintedanib







Accord Healthcare S.L.U.




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






EU/1/24/1803


Capsule, soft


L01EX09


24.4.2024




19.4.2024


Pyzchiva


ustekinumab







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1801


Concentrate for solution for injection
Solution for injection


L04AC05


24.4.2024




19.4.2024


Tizveni


tislelizumab







BeiGene Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/24/1797


Concentrate for solution for infusion


 


22.4.2024




19.4.2024


Voydeya


danicopan







Alexion Europe SAS




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






EU/1/24/1792


Film-coated tablet


L04AJ09


25.4.2024




19.4.2024


ZYNYZ


retifanlimab







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/24/1800


Concentrate for solution for infusion


L01FF10


24.4.2024




22.4.2024


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/1/24/1811


Gastro-resistant capsule, hard


L04AX07


24.4.2024




22.4.2024


Dimethyl fumarate Mylan


dimethyl fumarate







Mylan Ireland Limited




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






EU/1/24/1814


Gastro-resistant capsule, hard


L04AX07


22.4.2024




22.4.2024


Dimethyl fumarate Neuraxpharm


dimethyl fumarate







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/24/1810


Gastro-resistant capsule, hard


L04AX07


22.4.2024




22.4.2024


Emblaveo


aztreonam / avibactam







Pfizer Europe MA EEIG




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






EU/1/24/1808


Powder for concentrate for solution for infusion


J01DF51


22.4.2024




—   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




5.4.2024


Alofisel







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/17/1261


8.4.2024




5.4.2024


Clopidogrel/Acetylsalicylic acid Viatris







Viatris Limited




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






EU/1/19/1395


8.4.2024




5.4.2024


Entecavir Viatris







Viatris Limited




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






EU/1/17/1227


8.4.2024




5.4.2024


Epidyolex







Jazz Pharmaceuticals Ireland Ltd




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






EU/1/19/1389


8.4.2024




5.4.2024


Febuxostat Viatris







Viatris Limited




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






EU/1/17/1194


8.4.2024




5.4.2024


Lacosamide UCB







UCB Pharma S.A.




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






EU/1/19/1383


8.4.2024




5.4.2024


Lokelma







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1173


8.4.2024




5.4.2024


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


8.4.2024




5.4.2024


Orkambi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/15/1059


8.4.2024




5.4.2024


Perjeta







Roche Registration GmbH




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






EU/1/13/813


8.4.2024




9.4.2024


Anagrelide Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/17/1256


10.4.2024




9.4.2024


Clopidogrel/Acetylsalicylic acid Viatris







Viatris Limited




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






EU/1/19/1395


10.4.2024




9.4.2024


Drovelis







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1547


11.4.2024




9.4.2024


Entecavir Viatris







Viatris Limited




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






EU/1/17/1227


10.4.2024




9.4.2024


Febuxostat Viatris







Viatris Limited




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






EU/1/17/1194


10.4.2024




9.4.2024


Inhixa







Techdow Pharma Netherlands B.V.




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






EU/1/16/1132


15.4.2024




9.4.2024


Orfadin







Swedish Orphan Biovitrum International AB




112 76 Stockholm, Sverige






EU/1/04/303


11.4.2024




9.4.2024


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


10.4.2024




9.4.2024


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


10.4.2024




9.4.2024


Prasugrel Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1273


10.4.2024




9.4.2024


Zalasta







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/07/415


15.4.2024




9.4.2024


Zeposia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1442


10.4.2024




9.4.2024


Zoonotic Influenza Vaccine Seqirus







Seqirus S.r.l.




Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia






EU/1/23/1761


10.4.2024




11.4.2024


Fingolimod Mylan







Mylan Ireland Limited




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






EU/1/21/1573


15.4.2024




15.4.2024


Moventig







Grünenthal GmbH




Zieglerstraße 6, 52078, Aachen, Deutschland






EU/1/14/962


17.4.2024




15.4.2024


Talzenna







Pfizer Europe MA EEIG




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






EU/1/19/1377


16.4.2024




19.4.2024


Atazanavir Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1091


22.4.2024




19.4.2024


Biktarvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/18/1289


22.4.2024




19.4.2024


Bimzelx







UCB Pharma S.A.




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






EU/1/21/1575


23.4.2024




19.4.2024


Dupixent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1229


23.4.2024




19.4.2024


Emtricitabine/Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1148


22.4.2024




19.4.2024


Gilenya







Novartis Europharm Limited




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






EU/1/11/677


23.4.2024




19.4.2024


Jentadueto







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/12/780


22.4.2024




19.4.2024


Koselugo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1552


22.4.2024




19.4.2024


Lamivudine Teva Pharma B.V.







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/596


22.4.2024




19.4.2024


Leqvio







Novartis Europharm Limited




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






EU/1/20/1494


23.4.2024




19.4.2024


Lunsumio







Roche Registration GmbH




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






EU/1/22/1649


22.4.2024




19.4.2024


Lyxumia







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/12/811


22.4.2024




19.4.2024


Mounjaro







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/22/1685


22.4.2024




19.4.2024


Onglyza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/09/545


22.4.2024




19.4.2024


Palynziq







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/19/1362


22.4.2024




19.4.2024


Pandemic influenza vaccine H5N1 AstraZeneca







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1089


22.4.2024




19.4.2024


Pluvicto







Novartis Europharm Limited




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






EU/1/22/1703


26.4.2024




19.4.2024


Potactasol







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/10/660


23.4.2024




19.4.2024


Pramipexole Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/490


22.4.2024




19.4.2024


Qtern







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1108


22.4.2024




19.4.2024


Rivastigmine Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/11/693


25.4.2024




19.4.2024


Sivextro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/991


22.4.2024




19.4.2024


Spedra







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/13/841


23.4.2024




19.4.2024


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


22.4.2024




19.4.2024


Teriflunomide Accord







Accord Healthcare S.L.U.




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






EU/1/22/1693


24.4.2024




19.4.2024


Twinrix Adult







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/96/020


24.4.2024




19.4.2024


Twinrix Paediatric







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/97/029


24.4.2024




19.4.2024


Ultomiris







Alexion Europe SAS




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






EU/1/19/1371


29.4.2024




19.4.2024


Xeplion







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/672


22.4.2024




19.4.2024


Xtandi







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/13/846


25.4.2024




25.4.2024


Ambirix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/02/224


26.4.2024




25.4.2024


BYANNLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1453


26.4.2024




25.4.2024


Colobreathe







Essential Pharma Limited




Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara CBD 1070, Malta






EU/1/11/747


30.4.2024




25.4.2024


Granpidam







Accord Healthcare S.L.U.




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






EU/1/16/1137


26.4.2024




25.4.2024


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/12/782


26.4.2024




25.4.2024


Krazati







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1744


6.5.2024




25.4.2024


Levetiracetam Actavis Group







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/11/738


26.4.2024




25.4.2024


Lydisilka







Estetra SRL




Rue Saint Georges 5-7, 4000 Liège, Belgique






EU/1/21/1548


26.4.2024




25.4.2024


LysaKare







Advanced Accelerator Applications




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






EU/1/19/1381


26.4.2024




25.4.2024


Onivyde pegylated liposomal







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/16/1130


30.4.2024




25.4.2024


Yselty







Theramex Ireland Limited




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






EU/1/21/1606


29.4.2024




29.4.2024


Luxturna







Novartis Europharm Limited




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






EU/1/18/1331


1.5.2024




29.4.2024


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


6.5.2024




29.4.2024


Xerava







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/18/1312


6.5.2024




—   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




19.4.2024


Telmisartan Teva Pharma







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/719


22.4.2024




—   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




8.4.2024


Alcort


hydrocortisone aceponate







NEXTMUNE ITALY S.R.L.




Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR), Italia






EU/2/24/306


Cutaneous spray, solution


QD07AC16


9.4.2024




8.4.2024


Lexylan


cefalexin







Emdoka




John Lijsenstraat 16, 2321 Hoogstraten, België






EU/2/24/308


Suspension for injection


QJ01DB01


10.4.2024




9.4.2024


DIVENCE PENTA


Bovine viral diarrhoea (subunit), bovine parainfluenza 3 virus (inactivated), bovine respiratory syncytial virus and bovine herpesvirus type 1 (live) vaccine







Laboratorios Hipra, S.A.




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






EU/2/24/307


Lyophilisate and solvent for solution for injection


QI02AH


10.4.2024




25.4.2024


Lotimax


lotilaner







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/24/311


Chewable tablet


QP53BE04


29.4.2024




—   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




8.4.2024


Aivlosin







ECO Animal Health Europe Limited




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






EU/2/04/044


12.4.2024




8.4.2024


Chanhold







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/19/236


15.4.2024




8.4.2024


Daxocox







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/21/270


9.4.2024




8.4.2024


Draxxin







Zoetis Belgium




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






EU/2/03/041


10.4.2024




8.4.2024


Incurin







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/00/018


11.4.2024




9.4.2024


Aivlosin







ECO Animal Health Europe Limited




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






EU/2/04/044


12.4.2024




9.4.2024


Lydaxx







VETOQUINOL S.A.




Magny-Vernois, 70200 Lure, France






EU/2/20/253


10.4.2024




9.4.2024


OvuGel







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/20/260


10.4.2024




9.4.2024


Strangvac







Intervacc AB




Vastertorpsvagen 135, 129 44 Hagersten, Sverige






EU/2/21/274


10.4.2024




11.4.2024


Tulissin







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/20/252


12.4.2024




25.4.2024


Halocur







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/99/013


26.4.2024




25.4.2024


Nobilis IB Primo QX







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/14/174


29.4.2024




25.4.2024


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


30.4.2024




25.4.2024


Purevax RCP







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/052


29.4.2024




25.4.2024


Senvelgo







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/23/305


29.4.2024




25.4.2024


Tulaven







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/251


26.4.2024




29.4.2024


Coliprotec F4/F18







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/202


30.4.2024




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/2024/3355/oj
ISSN 1977-091X (electronic edition)