Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2024 to 31 March 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: 2024-04-30
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_202402791EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/2791


30.4.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2024 to 31 March 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/2024/2791)

—   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




19.03.2024


Abecma


idecabtagene vicleucel







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


Dispersion for infusion


L01


22.03.2024




21.03.2024


EXBLIFEP


cefepime / enmetazobactam







Advanz Pharma Limited




Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Co. Dublin, Ireland






EU/1/24/1794


Powder for concentrate for solution for infusion


J01DE51


23.03.2024




21.03.2024


Niapelf


Paliperidone







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/24/1795


Prolonged-release suspension for injection


N05AX13


02.04.2024




21.03.2024


Ryzneuta


efbemalenograstim alfa







Evive Biotechnology Ireland LTD




Second Floor, Joshua Dawson House, Dawson Street, Dublin, D02 RY95, Ireland






EU/1/24/1793


Solution for injection


L03AA18


22.03.2024




—   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




01.03.2024


Evicel







Omrix Biopharmaceuticals N.V.




Leonardo Da Vincilaan 15, 1831 Diegem, België






EU/1/08/473


06.03.2024




01.03.2024


Nityr







Cycle Pharmaceuticals (Europe) Ltd




70 Sir John Rogerson's Quay, Dublin 2, D02 R296, Ireland






EU/1/18/1290


04.03.2024




01.03.2024


Pepaxti







Oncopeptides AB (publ)




Luntmakargatan 46, 111 37 Stockholm, Sverige






EU/1/22/1669


04.03.2024




01.03.2024


Zercepac







Accord Healthcare S.L.U.




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






EU/1/20/1456


04.03.2024




01.03.2024


Zoledronic acid Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/12/759


04.03.2024




11.03.2024


CARVYKTI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1648


13.03.2024




11.03.2024


Ecansya







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/12/763


12.03.2024




11.03.2024


Ondexxya







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1345


12.03.2024




11.03.2024


Prevenar 20







Pfizer Europe MA EEIG




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






EU/1/21/1612


12.03.2024




11.03.2024


Striascan







CIS bio international




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






EU/1/19/1372


12.03.2024




11.03.2024


Upstaza







PTC Therapeutics International Limited




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






EU/1/22/1653


12.03.2024




11.03.2024


Waylivra







Akcea Therapeutics Ireland Ltd




St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland






EU/1/19/1360


12.03.2024




14.03.2024


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/07/419


15.03.2024




14.03.2024


Epysqli







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/23/1735


19.03.2024




14.03.2024


Firazyr







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/08/461


15.03.2024




14.03.2024


Inbrija







Acorda Therapeutics Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/19/1390


21.03.2024




14.03.2024


Infanrix hexa







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/00/152


04.04.2024




14.03.2024


JEVTANA







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/11/676


15.03.2024




14.03.2024


Mozobil







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/09/537


15.03.2024




14.03.2024


Tarceva







Roche Registration GmbH




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






EU/1/05/311


15.03.2024




14.03.2024


Yargesa







Piramal Critical Care B.V.




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






EU/1/17/1176


19.03.2024




14.03.2024


Zabdeno







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1444


15.03.2024




18.03.2024


Mekinist







Novartis Europharm Limited




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






EU/1/14/931


20.03.2024




19.03.2024


Braftovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1314


21.03.2024




19.03.2024


Fintepla







UCB Pharma S.A.




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






EU/1/20/1491


21.03.2024




19.03.2024


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


20.03.2024




19.03.2024


Plegridy







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/14/934


20.03.2024




19.03.2024


Qarziba







Recordati Netherlands B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/17/1191


22.03.2024




19.03.2024


Xromi







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland






EU/1/19/1366


20.03.2024




21.03.2024


Aldurazyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/03/253


22.03.2024




21.03.2024


Ambrisentan Mylan







Mylan Pharmaceuticals Limited




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






EU/1/19/1368


25.03.2024




21.03.2024


BIMERVAX







Hipra Human Health, S.L.U.




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






EU/1/22/1709


22.03.2024




21.03.2024


Celdoxome pegylated liposomal







Baxter Holding B.V.




Kobaltweg 49, 3542 CE Utrecht, Nederland






EU/1/22/1666


02.04.2024




21.03.2024


Cibinqo







Pfizer Europe MA EEIG




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






EU/1/21/1593


22.03.2024




21.03.2024


Clopidogrel ratiopharm







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/14/975


26.03.2024




21.03.2024


Dovato







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/19/1370


22.03.2024




21.03.2024


Enjaymo







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/22/1687


27.03.2024




21.03.2024


Giapreza







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/19/1384


22.03.2024




21.03.2024


Lunsumio







Roche Registration GmbH




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






EU/1/22/1649


22.03.2024




21.03.2024


Mektovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1315


22.03.2024




21.03.2024


Nemdatine







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/13/824


22.03.2024




21.03.2024


Nexviadyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1579


27.03.2024




21.03.2024


Ozempic







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1251


22.03.2024




21.03.2024


Spikevax


MODERNA BIOTECH SPAIN, S.L.


EU/1/20/1507


25.03.2024




21.03.2024


Tepadina







ADIENNE S.r.l.S.U.




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






EU/1/10/622


25.03.2024




21.03.2024


Uplizna







Horizon Therapeutics Ireland DAC




70 St. Stephen’s Green, Dublin 2, D02 E2X4, Ireland






EU/1/21/1602


22.03.2024




21.03.2024


Wegovy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/21/1608


22.03.2024




25.03.2024


ABILIFY MAINTENA







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/13/882


05.04.2024




25.03.2024


Aerinaze







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/07/399


26.03.2024




25.03.2024


CellCept







Roche Registration GmbH




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






EU/1/96/005


26.03.2024




25.03.2024


GAVRETO







Roche Registration GmbH




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






EU/1/21/1555


26.03.2024




25.03.2024


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


02.04.2024




25.03.2024


Mycophenolate mofetil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/439


26.03.2024




25.03.2024


Myfenax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/438


26.03.2024




25.03.2024


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


26.03.2024




25.03.2024


PecFent







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/10/644


27.03.2024




25.03.2024


Rapiscan







GE Healthcare AS




Nycoveien 1, 0485, Oslo, Norge






EU/1/10/643


26.03.2024




25.03.2024


Sutent







Pfizer Europe MA EEIG




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






EU/1/06/347


26.03.2024




25.03.2024


Zolgensma







Novartis Europharm Limited




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






EU/1/20/1443


27.03.2024




26.03.2024


Glivec







Novartis Europharm Limited




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






EU/1/01/198


02.04.2024




27.03.2024


Anagrelide Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/17/1256


02.04.2024




27.03.2024


Brilique







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/10/655


02.04.2024




27.03.2024


Cetrotide







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/99/100


03.04.2024




27.03.2024


Effentora







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/441


03.04.2024




27.03.2024


Febuxostat Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/18/1347


04.04.2024




27.03.2024


Instanyl







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/09/531


03.04.2024




27.03.2024


Myclausen







Passauer Pharma GmbH




Eiderstedter Weg 3, 14129 Berlin, Deutschland






EU/1/10/647


04.04.2024




27.03.2024


Nexium Control







GlaxoSmithKline Dungarvan Limited




Dungarvan, Co. Waterford, Ireland






EU/1/13/860


02.04.2024




27.03.2024


Ocrevus







Roche Registration GmbH




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






EU/1/17/1231


02.04.2024




27.03.2024


Prasugrel Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1273


02.04.2024




27.03.2024


Puregon







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/96/008


02.04.2024




27.03.2024


Reblozyl







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1452


02.04.2024




27.03.2024


Repatha







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1016


02.04.2024




27.03.2024


Rybelsus







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1430


03.04.2024




27.03.2024


Segluromet







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1265


02.04.2024




27.03.2024


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


02.04.2024




27.03.2024


Uptravi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/15/1083


02.04.2024




27.03.2024


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


02.04.2024




—   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




01.03.2024


Zoledronic acid Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/12/759


04.03.2024




11.03.2024


VidPrevtyn Beta







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/21/1580


12.03.2024




27.03.2024


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


02.04.2024




—   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




11.03.2024


Profender







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/05/054


12.03.2024




21.03.2024


Baycox Iron







Elanco Animal Health GmbH




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






EU/2/19/239


22.03.2024




21.03.2024


ReproCyc ParvoFLEX







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/237


25.03.2024




27.03.2024


AdTab







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/22/288


02.04.2024




27.03.2024


Credelio







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/206


02.04.2024




27.03.2024


Suprelorin







VIRBAC S.A.




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






EU/2/07/072


02.04.2024




—   Withdrawal 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)









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




27.03.2024


Bovilis Blue-8







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/218


02.04.2024




27.03.2024


Enteroporc Coli







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/268


02.04.2024




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/2024/2791/oj
ISSN 1977-091X (electronic edition)