Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2023 to 31 May 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: 2023-06-30
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_2023232EN.01000101.xml










30.6.2023   


EN


Official Journal of the European Union


C 232/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2023 to 31 May 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))
(2023/C 232/01)






—



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




4.5.2023


Elfabrio


pegunigalsidase alfa







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/23/1724


Concentrate for solution for infusion


A16AB20


5.5.2023




4.5.2023


Tibsovo


ivosidenib







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/23/1728


Film-coated tablet


L01XX62


8.5.2023




15.5.2023


Hyftor


sirolimus







Plusultra pharma GmbH




Fritz-Vomfelde-Str. 36, 40547 Düsseldorf, Deutschland






EU/1/23/1723


Gel


L04AA10


26.5.2023




26.5.2023


Dabigatran Etexilate Accord


dabigatran etexilate







Accord Healthcare S.L.U.




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






EU/1/22/1665


Capsule, hard


B01AE07


30.5.2023




26.5.2023


Epysqli


eculizumab







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/23/1735


Concentrate for solution for infusion


L04AA25


31.5.2023




26.5.2023


Omvoh


mirikizumab







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1736


Concentrate for solution for infusion
Solution for injection


L04AC


30.5.2023




26.5.2023


Pedmarqsi


sodium thiosulfate







Fennec Pharmaceuticals (EU) Limited




Block A, 5th Floor, The Atrium, Blackthorn Road, Sandyford, Dublin 18, Ireland






EU/1/23/1734


Solution for infusion


Pending


5.6.2023




26.5.2023


Qaialdo


spironolactone







Nova Laboratories Ireland Limited




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






EU/1/23/1731


Oral suspension


C03DA01


31.5.2023




26.5.2023


Sugammadex Adroiq


sugammadex







Extrovis EU Ltd.




Pátriárka utca 14., 2000, Szentendre, Magyarország






EU/1/23/1733


Solution for injection


V03AB35


30.5.2023




31.5.2023


Briumvi


ublituximab







Propharma Group The Netherlands B.V.




Schipholweg 73, 2316 ZL Leiden, Zuid-Holland, Nederland






EU/1/23/1730


Concentrate for solution for infusion


L04AG14


1.6.2023




31.5.2023


Lacosamide Adroiq


lacosamide







Extrovis EU Ltd.




Pátriárka utca 14., 2000, Szentendre, Magyarország






EU/1/23/1732


Solution for infusion


N03AX18


1.6.2023










—



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




2.5.2023


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/13/837


3.5.2023




4.5.2023


Carmustine Obvius







Obvius Investment B.V.




De Cuserstraat 93, 1081 CN Amsterdam, Nederland






EU/1/18/1278


5.5.2023




4.5.2023


Fampridine Accord







Accord Healthcare S.L.U.




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






EU/1/20/1477


5.5.2023




4.5.2023


Leflunomide medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/10/637


8.5.2023




4.5.2023


Nityr







Cycle Pharmaceuticals (Europe) Ltd




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






EU/1/18/1290


5.5.2023




4.5.2023


Riltrava Aerosphere







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1604


5.5.2023




5.5.2023


Arsenic trioxide Mylan







Mylan Ireland Limited




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






EU/1/20/1427


8.5.2023




5.5.2023


Benlysta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/11/700


9.5.2023




5.5.2023


Gazyvaro







Roche Registration GmbH




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






EU/1/14/937


8.5.2023




5.5.2023


Leflunomide ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/10/654


9.5.2023




5.5.2023


Leflunomide Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/09/604


8.5.2023




5.5.2023


OXERVATE







Dompé farmaceutici S.p.A.




Via Santa Lucia 6, 20122 Milano, Italia






EU/1/17/1197


8.5.2023




5.5.2023


Pritor







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/98/089


8.5.2023




5.5.2023


Rivastigmine Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/11/693


8.5.2023




5.5.2023


Samsca







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/09/539


10.5.2023




5.5.2023


Temozolomide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/606


8.5.2023




5.5.2023


Ultomiris







Alexion Europe SAS




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






EU/1/19/1371


15.5.2023




5.5.2023


Vfend







Pfizer Europe MA EEIG




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






EU/1/02/212


8.5.2023




5.5.2023


Waylivra







Akcea Therapeutics Ireland Ltd




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






EU/1/19/1360


12.5.2023




15.5.2023


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


25.5.2023




15.5.2023


Lenvima







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/15/1002


16.5.2023




15.5.2023


Nexavar







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/06/342


16.5.2023




15.5.2023


Selincro







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/12/815


22.5.2023




15.5.2023


Tenkasi







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/15/989


16.5.2023




15.5.2023


TRIXEO AEROSPHERE







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1498


16.5.2023




15.5.2023


Veltassa







Vifor Fresenius Medical Care Renal Pharma France




100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France






EU/1/17/1179


16.5.2023




23.5.2023


Arsenic Trioxide Accord







Accord Healthcare S.L.U.




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






EU/1/19/1398


24.5.2023




23.5.2023


Javlor







PIERRE FABRE MEDICAMENT




Les Cauquillous, 81500 Lavaur, France






EU/1/09/550


31.5.2023




23.5.2023


Levetiracetam Actavis Group







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/11/738


24.5.2023




23.5.2023


Rhokiinsa







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/19/1400


25.5.2023




26.5.2023


AYVAKYT







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/20/1473


30.5.2023




26.5.2023


BLENREP







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/20/1474


30.5.2023




26.5.2023


Cosentyx







Novartis Europharm Limited




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






EU/1/14/980


31.5.2023




26.5.2023


Defitelio







Gentium S.r.I.




Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia






EU/1/13/878


30.5.2023




26.5.2023


Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1133


31.5.2023




26.5.2023


Entresto







Novartis Europharm Limited




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






EU/1/15/1058


31.5.2023




26.5.2023


IBRANCE







Pfizer Europe MA EEIG




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






EU/1/16/1147


30.5.2023




26.5.2023


Jardiance







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


31.5.2023




26.5.2023


Kanuma







Alexion Europe SAS




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






EU/1/15/1033


6.6.2023




26.5.2023


Kentera







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/03/270


31.5.2023




26.5.2023


Levetiracetam ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/11/702


31.5.2023




26.5.2023


Levetiracetam SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/11/741


6.6.2023




26.5.2023


Lojuxta







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/13/851


30.5.2023




26.5.2023


Luveris







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/00/155


30.5.2023




26.5.2023


Neparvis







Novartis Europharm Limited




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






EU/1/16/1103


31.5.2023




26.5.2023


Nerlynx







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1311


30.5.2023




26.5.2023


OBIZUR







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/15/1035


30.5.2023




26.5.2023


Onpattro







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/18/1320


31.5.2023




26.5.2023


Oxbryta







Global Blood Therapeutics Netherlands B.V.




Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland






EU/1/21/1622


5.6.2023




26.5.2023


QUVIVIQ







Idorsia Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/22/1638


2.6.2023




26.5.2023


Replagal







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/01/189


30.5.2023




26.5.2023


Ronapreve







Roche Registration GmbH




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






EU/1/21/1601


30.5.2023




26.5.2023


RXULTI







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/18/1294


7.6.2023




26.5.2023


Spikevax







MODERNA BIOTECH SPAIN, S.L.




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






EU/1/20/1507


30.5.2023




26.5.2023


Vemlidy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1154


30.5.2023




31.5.2023


Adempas







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/907


1.6.2023




31.5.2023


Advagraf







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/07/387


6.6.2023




31.5.2023


Bimzelx







UCB Pharma S.A.




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






EU/1/21/1575


1.6.2023




31.5.2023


Bylvay







Albireo AB




Arvid Wallgrens Backe 20, 413 46 Gothenburg, Sverige






EU/1/21/1566


3.6.2023




31.5.2023


Cinacalcet Accordpharma







Accord Healthcare S.L.U.




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






EU/1/20/1429


1.6.2023




31.5.2023


Koselugo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1552


1.6.2023




31.5.2023


Kovaltry







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/15/1076


1.6.2023




31.5.2023


Libmeldy







Orchard Therapeutics (Netherlands) B.V.




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






EU/1/20/1493


5.6.2023




31.5.2023


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


1.6.2023




31.5.2023


Rekovelle







Ferring Pharmaceuticals A/S




Amager Strandvej 405, 2770 Kastrup, Danmark






EU/1/16/1150


2.6.2023




31.5.2023


Tecovirimat SIGA







SIGA Technologies Netherlands B.V.




Prinsenhil 29, Breda 4825 AX, Nederland






EU/1/21/1600


6.6.2023




31.5.2023


Ultomiris







Alexion Europe SAS




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






EU/1/19/1371


5.6.2023




31.5.2023


Viread







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/01/200


1.6.2023




31.5.2023


YERVOY







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


1.6.2023




31.5.2023


Zejula







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1235


7.6.2023




31.5.2023


Zostavax







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/341


7.6.2023




31.5.2023


Zyllt







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/553


2.6.2023










—



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




16.5.2023


Newflend ND H9


Newcastle disease and avian Influenza vaccine (live, recombinant)







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/23/296


Concentrate and solvent for suspension for injection


QI01AD


17.5.2023










—



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




4.5.2023


Bravecto Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/18/224


5.5.2023




4.5.2023


Equilis West Nile







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/151


5.5.2023




4.5.2023


Innovax-ILT







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/182


5.5.2023




4.5.2023


Prevomax







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/17/211


15.5.2023




4.5.2023


Versican Plus L4







Zoetis Belgium




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






EU/2/14/171


5.5.2023




16.5.2023


Bravecto







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/158


17.5.2023




16.5.2023


Dany’s BienenWohl







Dany Bienenwohl GmbH




Geyerspergerstraße 27, 80689 München, Deutschland






EU/2/18/225


17.5.2023




16.5.2023


NexGard Combo







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/267


19.5.2023




16.5.2023


Nobilis Influenza H5N2







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/06/061


17.5.2023




16.5.2023


Porcilis PCV M Hyo







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/14/175


22.5.2023




16.5.2023


Poulvac E. coli







Zoetis Belgium




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






EU/2/12/140


22.5.2023




16.5.2023


Stronghold







Zoetis Belgium




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






EU/2/99/014


17.5.2023




16.5.2023


Versican Plus Pi







Zoetis Belgium




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






EU/2/14/168


17.5.2023




16.5.2023


Versican Plus Pi/L4







Zoetis Belgium SA




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






EU/2/14/172


17.5.2023




26.5.2023


Purevax RCPCh FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/047


30.5.2023




26.5.2023


Suvaxyn PRRS MLV







Zoetis Belgium




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






EU/2/17/215


30.5.2023




26.5.2023


Syvazul BTV







LABORATORIOS SYVA, S.A.U.




Av. Párroco Pablo Diez 49-57, 24010 León, España






EU/2/18/231


30.5.2023




26.5.2023


UBAC







Laboratorios Hipra, S.A.




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






EU/2/18/227


5.6.2023




26.5.2023


Vaxxitek HVT + IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/02/032


30.5.2023










—



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




16.5.2023


Aftovaxpur Doe







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/13/153


19.5.2023




16.5.2023


Comfortis







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/10/115


30.5.2023




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.