Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2023 to 31 October 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: 2023-12-29
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_202301561EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2023/1561


29.12.2023






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2023 to 31 October 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/2023/1561)

—   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




9.10.2023


Zoonotic Influenza Vaccine Seqirus


zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)







Seqirus S.r.l.




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






EU/1/23/1761


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


J07BB02


10.10.2023




30.10.2023


Jaypirca


pirtobrutinib







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1738


Film-coated tablet


Pending


31.10.2023




—   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




4.10.2023


Apexxnar







Pfizer Europe MA EEIG




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






EU/1/21/1612


5.10.2023




4.10.2023


Benepali







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/15/1074


6.10.2023




4.10.2023


Bexsero







GlaxoSmithKline Vaccines S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/12/812


5.10.2023




4.10.2023


CABOMETYX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/16/1136


5.10.2023




4.10.2023


Dovprela







Mylan IRE Healthcare Limited




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






EU/1/20/1437


5.10.2023




4.10.2023


NEXPOVIO







Stemline Therapeutics B.V.




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






EU/1/21/1537


5.10.2023




4.10.2023


Ontruzant







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1241


10.10.2023




4.10.2023


Ravicti







Immedica Pharma AB




SE-113 63, Stockholm, Sverige






EU/1/15/1062


5.10.2023




4.10.2023


Trumenba







Pfizer Europe MA EEIG




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






EU/1/17/1187


5.10.2023




4.10.2023


Upstaza







PTC Therapeutics International Limited




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






EU/1/22/1653


5.10.2023




4.10.2023


Vazkepa







Amarin Pharmaceuticals Ireland Limited




88 Harcourt Street, Dublin 2, D02DK18, Ireland






EU/1/20/1524


12.10.2023




4.10.2023


Xyrem







UCB Pharma S.A.




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






EU/1/05/312


9.10.2023




5.10.2023


Artesunate Amivas







Amivas Ireland Ltd




Suite 5, Second Floor, Station House, Railway Square, Waterford, Ireland






EU/1/21/1582


6.10.2023




5.10.2023


Evkeeza







Ultragenyx Germany GmbH




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






EU/1/21/1551


6.10.2023




5.10.2023


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


6.10.2023




5.10.2023


Ontozry







Angelini Pharma S.p.A




Viale Amelia 70, 00181 Rome, Italia






EU/1/21/1530


9.10.2023




9.10.2023


Aerius







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/160


10.10.2023




9.10.2023


Aripiprazole Mylan Pharma







Mylan Pharmaceuticals Limited




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






EU/1/15/1005


10.10.2023




9.10.2023


Avonex







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/97/033


13.10.2023




9.10.2023


Azomyr







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/157


10.10.2023




9.10.2023


Briumvi







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/23/1730


11.10.2023




9.10.2023


Bronchitol







Pharmaxis Europe Limited




108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland






EU/1/12/760


11.10.2023




9.10.2023


Cinryze







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/11/688


10.10.2023




9.10.2023


EDURANT







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/736


10.10.2023




9.10.2023


Effentora







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/441


12.10.2023




9.10.2023


Filgrastim Hexal







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/08/496


10.10.2023




9.10.2023


Filsuvez







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/22/1652


10.10.2023




9.10.2023


Isentress







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/436


13.10.2023




9.10.2023


Neoclarityn







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/161


10.10.2023




9.10.2023


Olanzapine Apotex







Apotex Europe B.V.




Baarnsche Dijk 1, 3741 LN Baarn, Nederland






EU/1/10/635


18.10.2023




9.10.2023


Orladeyo







Biocryst Ireland Limited




Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland






EU/1/21/1544


10.10.2023




9.10.2023


Rivastigmine Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/09/599


12.10.2023




9.10.2023


Shingrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/18/1272


10.10.2023




9.10.2023


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


12.10.2023




9.10.2023


Ucedane







Eurocept International B.V.




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/17/1202


12.10.2023




9.10.2023


Vizarsin







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/551


10.10.2023




9.10.2023


Zarzio







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/08/495


10.10.2023




10.10.2023


Regkirona







Celltrion Healthcare Hungary Kft.




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






EU/1/21/1597


13.10.2023




12.10.2023


ADCETRIS







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/12/794


13.10.2023




12.10.2023


Azarga







Novartis Europharm Limited




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






EU/1/08/482


13.10.2023




12.10.2023


Iclusig







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/13/839


13.10.2023




12.10.2023


Ivozall







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris, France






EU/1/19/1396


13.10.2023




12.10.2023


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


19.10.2023




12.10.2023


Silodyx







Recordati Ireland Ltd




Raheens East, Ringaskiddy Co. Cork P43 KD30, Ireland






EU/1/09/607


17.10.2023




12.10.2023


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


13.10.2023




12.10.2023


Xeloda







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/00/163


17.10.2023




18.10.2023


Atectura Breezhaler







Novartis Europharm Limited




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






EU/1/20/1439


20.10.2023




18.10.2023


Brintellix







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/13/891


23.10.2023




18.10.2023


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


19.10.2023




18.10.2023


Exelon







Novartis Europharm Limited




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






EU/1/98/066


20.10.2023




18.10.2023


Holoclar







Holostem S.r.l.




Via Glauco Gottardi 100, 41125 Modena, Italia






EU/1/14/987


19.10.2023




18.10.2023


Neuraceq







Life Radiopharma Berlin GmbH




Max-Planck-Straße 4, 12489 Berlin, Deutschland






EU/1/13/906


19.10.2023




18.10.2023


Nordimet







Nordic Group B.V.




Siriusdreef 41, 2132 WT Hoofddorp, Nederland






EU/1/16/1124


24.10.2023




18.10.2023


Noxafil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/320


19.10.2023




18.10.2023


Nuwiq







Octapharma AB




Lars Forssells gata 23, 112 75 Stockholm, Sverige






EU/1/14/936


20.10.2023




18.10.2023


Olumiant







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/16/1170


19.10.2023




18.10.2023


Oxlumo







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/20/1496


19.10.2023




18.10.2023


Qutenza







Grünenthal GmbH




Zieglerstraße 6, 52078, Aachen, Deutschland






EU/1/09/524


23.10.2023




18.10.2023


Rebetol







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/107


20.10.2023




18.10.2023


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Industriestraße 18 83607 Holzkirchen Germany






EU/1/09/585


25.10.2023




19.10.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


20.10.2023




19.10.2023


Heplisav B







Dynavax GmbH




Eichsfelder Strasse 11, D-40595 Düsseldorf, Deutschland






EU/1/20/1503


20.10.2023




19.10.2023


HyQvia







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/13/840


24.10.2023




19.10.2023


Koselugo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1552


20.10.2023




19.10.2023


Lumykras







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1603


23.10.2023




19.10.2023


Maviret







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/17/1213


20.10.2023




19.10.2023


Odefsey







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1112


20.10.2023




19.10.2023


Oyavas







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/20/1510


23.10.2023




19.10.2023


Quinsair







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/973


26.10.2023




19.10.2023


Raxone







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/15/1020


20.10.2023




19.10.2023


Zokinvy







EigerBio Europe Limited




1 Castlewood Avenue, Rathmines, Dublin 6, D06 H685, Ireland






EU/1/22/1660


20.10.2023




24.10.2023


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


26.10.2023




24.10.2023


REKAMBYS







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1482


25.10.2023




24.10.2023


Voxzogo







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/21/1577


25.10.2023




24.10.2023


Zepatier







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1119


27.10.2023




26.10.2023


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


27.10.2023




26.10.2023


SonoVue







Bracco International B.V.




Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland






EU/1/01/177


7.11.2023




30.10.2023


Emtriva







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/03/261


31.10.2023




30.10.2023


Flebogamma DIF







Instituto Grifols, S.A.




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






EU/1/07/404


31.10.2023




30.10.2023


Idacio







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1356


31.10.2023




30.10.2023


Nuvaxovid







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


31.10.2023




30.10.2023


Ryeqo







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1565


13.11.2023




31.10.2023


Nuvaxovid







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


31.10.2023




—   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




4.10.2023


Pregabalin Sandoz GmbH







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1012


9.10.2023




5.10.2023


Zynrelef







Heron Therapeutics, B.V.




Herengracht 500, 1017 CB Amsterdam, Nederland






EU/1/20/1478


16.10.2023




12.10.2023


Ciambra







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/15/1055


13.10.2023




12.10.2023


COVID-19 Vaccine (inactivated, adjuvanted) Valneva







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/21/1624


13.10.2023




18.10.2023


Ivozall







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris, France






EU/1/19/1396


24.10.2023




18.10.2023


Rebetol







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/107


20.10.2023




26.10.2023


Clopidogrel BGR







Laboratoires BIOGARAN




15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France






EU/1/09/558


31.10.2023




—   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




19.10.2023


Loxitab


meloxicam







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/23/301


Tablet


QM01AC06


24.10.2023




19.10.2023


Oxmax


hemoglobin betafumaril (bovine)







New Alpha Innovation Biopharmaceutical Ireland Limited




The Black Church, St. Mary’s Place, Dublin, D07 P4AX, Ireland






EU/2/23/299


Solution for infusion


QB05AA91


20.10.2023




24.10.2023


PREVEXXION RN+HVT


Marek's disease vaccine (live recombinant)







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/23/302


Concentrate and solvent for suspension for injection


QI01AD03


26.10.2023




26.10.2023


Poulvac Procerta HVT-IBD


Live recombinant turkey herpes virus, strain HVT-IBD, expressing the VP2 protein of infectious bursal disease virus







Zoetis Belgium




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






EU/2/23/300


Concentrate and solvent for suspension for injection


QI01AD15


27.10.2023




—   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




12.10.2023


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


16.10.2023




19.10.2023


AdTab







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/22/288


20.10.2023




19.10.2023


CLYNAV







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/197


20.10.2023




19.10.2023


Innovax-ND-ILT







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/20/256


20.10.2023




19.10.2023


Leucofeligen FeLV/RCP







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/09/097


20.10.2023




19.10.2023


Stronghold Plus







Zoetis Belgium




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






EU/2/16/204


25.10.2023




20.10.2023


Previcox







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/045


23.10.2023




24.10.2023


NEXGARD SPECTRA







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/14/177


26.10.2023




26.10.2023


Solensia







Zoetis Belgium SA




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






EU/2/20/269


27.10.2023




—   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




5.10.2023


CaniLeish







VIRBAC S.A.




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






EU/2/11/121


6.10.2023




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/2023/1561/oj
ISSN 1977-091X (electronic edition)