Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2023 to 30 September 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: 2023-10-31
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_202300298EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2023/298


31.10.2023






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2023 to 30 September 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/2023/298)

—   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




15.9.2023


Apretude


cabotegravir







ViiV Healthcare BV




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






EU/1/23/1760


Film-coated tablet
Prolonged-release suspension for injection


J05AJ04


20.9.2023




15.9.2023


Enrylaze


crisantaspase







Jazz Pharmaceuticals Ireland Limited




5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland






EU/1/23/1747


Solution for injection or infusion


L01XX02


21.9.2023




15.9.2023


Inaqovi


decitabine / cedazuridine







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/23/1756


Film-coated tablet


L01BC58


18.9.2023




15.9.2023


Litfulo


ritlecitinib







Pfizer Europe MA EEIG




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






EU/1/23/1755


Capsule, hard


L04AF08


18.9.2023




15.9.2023


Lyfnua


gefapixant







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/21/1613


Film-coated tablet


R05DB29


20.9.2023




15.9.2023


ORSERDU


elacestrant







Stemline Therapeutics B.V.




Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland






EU/1/23/1757


Film-coated tablet


L02BA04


18.9.2023




15.9.2023


Tevimbra


tislelizumab







Novartis Europharm Limited




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






EU/1/23/1758


Concentrate for solution for infusion


L01FF09


19.9.2023




15.9.2023


Tyenne


tocilizumab







Fresenius Kabi Deutschland GmbH




Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland






EU/1/23/1754


Concentrate for solution for infusion
Solution for injection


L04AC07


18.9.2023




15.9.2023


Yesafili


aflibercept







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/23/1751


Solution for injection in a vial


S01LA05


19.9.2023




22.9.2023


Tepkinly


epcoritamab







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/23/1759


Solution for injection


Pending


25.9.2023




22.9.2023


Tyruko


natalizumab







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/23/1745


Concentrate for solution for infusion


L04AA23


25.9.2023




29.9.2023


Degarelix Accord


degarelix acetate







Accord Healthcare S.L.U.




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






EU/1/23/1753


Powder and solvent for solution for injection


L02BX02


3.10.2023




—   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




1.9.2023


Adcirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/08/476


4.9.2023




1.9.2023


Adtralza







Leo Pharma A/S




Industriparken 55, 2750 Ballerup, Danmark






EU/1/21/1554


7.9.2023




1.9.2023


Emgality







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1330


4.9.2023




1.9.2023


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


4.9.2023




1.9.2023


Poteligeo







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/18/1335


19.9.2023




11.9.2023


Apealea







Inceptua AB




Gustavslundsv. 143, 16751 Bromma, Sverige






EU/1/18/1292


12.9.2023




11.9.2023


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


12.9.2023




11.9.2023


Fulphila







Biosimilar Collaborations Ireland Limited




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






EU/1/18/1329


12.9.2023




11.9.2023


GHRYVELIN







Atnahs Pharma Netherlands B.V.




Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark






EU/1/18/1337


15.9.2023




11.9.2023


Imlygic







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1064


13.9.2023




11.9.2023


Insuman







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/97/030


12.9.2023




11.9.2023


Irbesartan Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/06/376


14.9.2023




11.9.2023


Kaletra







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/01/172


12.9.2023




11.9.2023


Lumeblue







Alfasigma S.p.A.




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






EU/1/20/1470


12.9.2023




11.9.2023


OKEDI







Laboratorios Farmacéuticos Rovi, S.A.




Julián Camarillo 35, 28037 Madrid, España






EU/1/21/1621


12.9.2023




11.9.2023


Opatanol







Novartis Europharm Limited




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






EU/1/02/217


12.9.2023




11.9.2023


Rybrevant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


12.9.2023




11.9.2023


Vimizim







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/14/914


12.9.2023




12.9.2023


Fulphila







Biosimilar Collaborations Ireland Limited




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






EU/1/18/1329


14.9.2023




15.9.2023


Afinitor







Novartis Europharm Limited




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






EU/1/09/538


18.9.2023




15.9.2023


Amlodipine/Valsartan Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1092


18.9.2023




15.9.2023


Bevespi Aerosphere







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1339


22.9.2023




15.9.2023


Celsentri







ViiV Healthcare BV




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






EU/1/07/418


21.9.2023




15.9.2023


Clopidogrel Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/540


18.9.2023




15.9.2023


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1222


18.9.2023




15.9.2023


Esperoct







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/19/1374


21.9.2023




15.9.2023


Fortacin







Recordati Ireland Ltd




Raheens East, Ringaskiddy Co. Cork P43 KD30, Ireland






EU/1/13/881


21.9.2023




15.9.2023


GAVRETO







Roche Registration GmbH




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






EU/1/21/1555


18.9.2023




15.9.2023


Grepid







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/09/535


18.9.2023




15.9.2023


Hizentra







CSL Behring GmbH




Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland






EU/1/11/687


21.9.2023




15.9.2023


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


18.9.2023




15.9.2023


Instanyl







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/09/531


22.9.2023




15.9.2023


Irbesartan / Hydrochlorothiazide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/583


19.9.2023




15.9.2023


Iressa







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/09/526


18.9.2023




15.9.2023


Jinarc







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/15/1000


18.9.2023




15.9.2023


Kadcyla







Roche Registration GmbH




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






EU/1/13/885


18.9.2023




15.9.2023


Kinzalkomb







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/214


18.9.2023




15.9.2023


Kiovig







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/05/329


21.9.2023




15.9.2023


Levetiracetam Hospira







Pfizer Europe MA EEIG




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






EU/1/13/889


18.9.2023




15.9.2023


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/02/213


21.9.2023




15.9.2023


M-M-RVAXPRO







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/337


18.9.2023




15.9.2023


Olumiant







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/16/1170


18.9.2023




15.9.2023


Orgovyx







Accord Healthcare S.L.U.




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






EU/1/22/1642


18.9.2023




15.9.2023


Pregabalin Sandoz GmbH







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1012


18.9.2023




15.9.2023


Prolia







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/10/618


18.9.2023




15.9.2023


Remsima







Celltrion Healthcare Hungary Kft.




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






EU/1/13/853


18.9.2023




15.9.2023


Sitagliptin/Metformin hydrochloride Accord







Accord Healthcare S.L.U.




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






EU/1/22/1661


18.9.2023




15.9.2023


Spevigo







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/22/1688


18.9.2023




15.9.2023


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España






EU/1/20/1507


15.9.2023




15.9.2023


Sugammadex Mylan







Mylan Ireland Limited




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






EU/1/21/1583


19.9.2023




15.9.2023


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/13/837


19.9.2023




15.9.2023


Tenkasi







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/15/989


18.9.2023




15.9.2023


Tezspire







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1677


18.9.2023




15.9.2023


Toviaz







Pfizer Europe MA EEIG




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






EU/1/07/386


18.9.2023




15.9.2023


Tygacil







Pfizer Europe MA EEIG




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






EU/1/06/336


18.9.2023




15.9.2023


Vantobra







PARI Pharma GmbH




Moosstraße 3, 82319 Starnberg, Deutschland






EU/1/18/1350


19.9.2023




15.9.2023


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


18.9.2023




15.9.2023


Viagra







Upjohn EESV




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






EU/1/98/077


26.9.2023




15.9.2023


Vyvgart







argenx BV




Industriepark-Zwijnaarde 7, 9052 Gent, België






EU/1/22/1674


20.9.2023




15.9.2023


Xofigo







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/873


18.9.2023




15.9.2023


Zytiga







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/714


18.9.2023




18.9.2023


Rydapt







Novartis Europharm Limited




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






EU/1/17/1218


20.9.2023




22.9.2023


Ciambra







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/15/1055


25.9.2023




22.9.2023


Clopidogrel/Acetylsalicylic acid Mylan







Mylan Pharmaceuticals Limited




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






EU/1/19/1395


25.9.2023




22.9.2023


Erleada







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/18/1342


25.9.2023




22.9.2023


Imcivree







Rhythm Pharmaceuticals Netherlands B.V.




Radarweg 29, 1043 NX Amsterdam, Nederland






EU/1/21/1564


26.9.2023




22.9.2023


Imvanex







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/13/855


5.10.2023




22.9.2023


Kesimpta







Novartis Ireland Limited




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






EU/1/21/1532


3.10.2023




22.9.2023


Myozyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/333


28.9.2023




22.9.2023


Ranivisio







Midas Pharma GmbH




Rheinstraße 49, D-55218 Ingelheim, Deutschland






EU/1/22/1673


25.9.2023




22.9.2023


Sunosi







Atnahs Pharma Netherlands B. V.




Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Denmark






EU/1/19/1408


25.9.2023




22.9.2023


TAVLESSE







Instituto Grifols, S.A.




Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa






EU/1/19/1405


27.9.2023




22.9.2023


Vaxchora







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/20/1423


25.9.2023




22.9.2023


Vildagliptin/Metformin hydrochloride Accord







Accord Healthcare S.L.U.




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






EU/1/21/1611


26.9.2023




—   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




11.9.2023


Lenalidomide Krka d.d. Novo mesto







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1520


14.9.2023




11.9.2023


Pandemic influenza vaccine H5N1 BAXTER







Resilience Biomanufacturing Ireland Limited




2 Shelbourne Buildings, Crampton Avenue, Dublin 4, D04 W3V6, Ireland






EU/1/09/571


15.9.2023




—   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




11.9.2023


YURVAC RHD


Rabbit haemorrhagic disease and RHDV2 vaccine (recombinant)







Laboratorios Hipra, S.A.




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






EU/2/23/298


Emulsion for injection


QI08AV


12.9.2023




—   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




11.9.2023


Apoquel







Zoetis Belgium




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






EU/2/13/154


12.9.2023




11.9.2023


Prolevare







Zoetis Belgium




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






EU/2/23/295


12.9.2023




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/2023/298/oj
ISSN 1977-091X (electronic edition)