Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2023 to 31 July 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: 2023-08-31
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








C_2023309EN.01000101.xml










31.8.2023   


EN


Official Journal of the European Union


C 309/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2023 to 31 July 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 309/01)
—   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




4.7.2023


Lytgobi


futibatinib







Taiho Pharma Netherlands B.V.




Barbara Strozzilaan 201, 1083 HN Amsterdam, Noord-Holland, Nederland






EU/1/23/1741


Film-coated tablet


L01EN04


6.7.2023




4.7.2023


Nuvaxovid


COVID-19 Vaccine (recombinant, adjuvanted)







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


dispersion for injection


J07BX03


6.7.2023




7.7.2023


Columvi


glofitamab







Roche Registration GmbH




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






EU/1/23/1742


Concentrate for solution for infusion


L01FX28


10.7.2023




18.7.2023


Hepcludex


bulevirtide







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1446


Powder for solution for injection


J05AX28


19.7.2023




24.7.2023


Pylclari


piflufolastat (18F)







CURIUM PET France




Biopole Clermont-Limagne, 3 rue Marie Curie, 63360 Saint-Beauzire, France






EU/1/23/1746


Solution for injection


V09IX16


25.7.2023




26.7.2023


ZTALMY


ganaxolone







Marinus Pharmaceuticals Emerald Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland






EU/1/23/1743


Oral suspension


N03AX27


28.7.2023




—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




17.7.2023


SOHONOS







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






—


18.7.2023




—   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




4.7.2023


Clopidogrel Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/556


6.7.2023




4.7.2023


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland






EU/1/09/555


5.7.2023




4.7.2023


Clopidogrel Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/08/465


7.7.2023




4.7.2023


Kigabeq







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris, France






EU/1/18/1302


5.7.2023




4.7.2023


Levetiracetam Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/701


6.7.2023




4.7.2023


Mysimba







Orexigen Therapeutics Ireland Limited




2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland






EU/1/14/988


5.7.2023




4.7.2023


Orkambi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/15/1059


5.7.2023




4.7.2023


Ponvory







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1550


5.7.2023




4.7.2023


Uptravi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/15/1083


5.7.2023




4.7.2023


Vaxchora







Emergent Netherlands B.V.




Strawinskylaan 411, 1077 XX Amsterdam, Nederland






EU/1/20/1423


17.7.2023




4.7.2023


Zinforo







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/12/785


6.7.2023




7.7.2023


Buccolam







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/11/709


12.7.2023




7.7.2023


GAVRETO







Roche Registration GmbH




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






EU/1/21/1555


10.7.2023




7.7.2023


Lemtrada







Sanofi Belgium




Leonardo Da Vincilaan 19, B-1831 Diegem, België






EU/1/13/869


10.7.2023




7.7.2023


Pifeltro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1332


11.7.2023




7.7.2023


Piqray







Novartis Europharm Limited




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






EU/1/20/1455


10.7.2023




7.7.2023


Raxone







Santhera Pharmaceuticals (Deutschland) GmbH




Marie-Curie Straße 8, 79539 Lörrach, Deutschland






EU/1/15/1020


10.7.2023




7.7.2023


Rozlytrek







Roche Registration GmbH




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






EU/1/20/1460


10.7.2023




7.7.2023


VITRAKVI







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/19/1385


10.7.2023




17.7.2023


Byetta







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/06/362


18.7.2023




17.7.2023


Cerezyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/97/053


19.7.2023




17.7.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


18.7.2023




17.7.2023


Envarsus







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/935


18.7.2023




17.7.2023


Galvus







Novartis Europharm Limited




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






EU/1/07/414


18.7.2023




17.7.2023


Gardasil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/357


18.7.2023




17.7.2023


Gliolan







photonamic GmbH & Co. KG




Eggerstedter Weg 12, 25421 Pinneberg, Deutschland






EU/1/07/413


18.7.2023




17.7.2023


Hepcludex







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1446


18.7.2023




17.7.2023


Idefirix







Hansa Biopharma AB




P.O. Box 785, 220 07 Lund, Sverige






EU/1/20/1471


18.7.2023




17.7.2023


Jalra







Novartis Europharm Limited




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






EU/1/08/485


18.7.2023




17.7.2023


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/20/1468


18.7.2023




17.7.2023


Kapruvia







Vifor Fresenius Medical Care Renal Pharma France




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






EU/1/22/1643


18.7.2023




17.7.2023


Kinpeygo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/22/1657


18.7.2023




17.7.2023


Lenalidomide Krka







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1519


26.7.2023




17.7.2023


NULIBRY







TMC Pharma (EU) Limited




7a Durands Court, 45 Parnell Street, Waterford, Co. Waterford, X91 P381, Ireland






EU/1/22/1684


18.7.2023




17.7.2023


Ontilyv







Bial — Portela & Ca, SA




À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal






EU/1/21/1578


18.7.2023




17.7.2023


Somavert







Pfizer Europe MA EEIG




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






EU/1/02/240


18.7.2023




17.7.2023


Strimvelis







Fondazione Telethon ETS




Via Varese 16/B, 00185 Roma, Italia






EU/1/16/1097


18.7.2023




17.7.2023


Xiliarx







Novartis Europharm Limited




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






EU/1/08/486


18.7.2023




17.7.2023


Zeffix







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/99/114


25.7.2023




24.7.2023


Alunbrig







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/18/1264


8.8.2023




24.7.2023


Alymsys







Mabxience Research SL




C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España






EU/1/20/1509


25.7.2023




24.7.2023


Aripiprazole Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1009


25.7.2023




24.7.2023


AYVAKYT







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/20/1473


25.7.2023




24.7.2023


Fluad Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/20/1433


25.7.2023




24.7.2023


Flucelvax Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/18/1326


26.7.2023




24.7.2023


Ilumetri







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/18/1323


25.7.2023




24.7.2023


Jardiance







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


26.7.2023




24.7.2023


Luxturna







Novartis Europharm Limited




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






EU/1/18/1331


25.7.2023




24.7.2023


Metalyse







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/00/169


26.7.2023




24.7.2023


Minjuvi







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1570


25.7.2023




24.7.2023


Pemetrexed medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/15/1038


25.7.2023




24.7.2023


Pemetrexed Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1037


1.8.2023




24.7.2023


PritorPlus







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/215


25.7.2023




24.7.2023


Roctavian







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/22/1668


26.7.2023




24.7.2023


Scemblix







Novartis Europharm Limited




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






EU/1/22/1670


25.7.2023




24.7.2023


Sitagliptin SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/21/1598


2.8.2023




24.7.2023


Sogroya







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1501


25.7.2023




24.7.2023


Soliris







Alexion Europe SAS




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






EU/1/07/393


26.7.2023




24.7.2023


TECVAYLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1675


25.7.2023




24.7.2023


Vaborem







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/18/1334


25.7.2023




24.7.2023


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


25.7.2023




26.7.2023


Brintellix







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/13/891


28.7.2023




26.7.2023


Buvidal







Camurus AB




Ideon Science Park, 223 70 Lund, Sverige






EU/1/18/1336


27.7.2023




26.7.2023


Lixiana







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/15/993


28.7.2023




26.7.2023


Lonsurf







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/16/1096


27.7.2023




26.7.2023


Mircera







Roche Registration GmbH




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






EU/1/07/400


27.7.2023




26.7.2023


Ogluo







Tetris Pharma B.V




Bargelaan 200, Element Offices, 2333 CW Leiden, Nederland






EU/1/20/1523


1.8.2023




26.7.2023


Pemazyre







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1535


27.7.2023




26.7.2023


Pirfenidone axunio







axunio Pharma GmbH




Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland






EU/1/22/1655


27.7.2023




26.7.2023


Revlimid







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/391


27.7.2023




26.7.2023


Ruconest







Pharming Group N.V.




Darwinweg 24, 2333 CR Leiden, Nederland






EU/1/10/641


31.7.2023




26.7.2023


Siklos







THERAVIA




16 Rue Montrosier, 92200 Neuilly-sur-Seine, France






EU/1/07/397


27.7.2023




26.7.2023


Synagis







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/99/117


28.7.2023




26.7.2023


TAGRISSO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1086


27.7.2023




26.7.2023


Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1129


27.7.2023




26.7.2023


Thalidomide BMS







Bristol-Myers Squibb Pharma EEIG




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






EU/1/08/443


27.7.2023




26.7.2023


Trodelvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/21/1592


28.7.2023




26.7.2023


Vantobra







PARI Pharma GmbH




Moosstraße 3, 82319 Starnberg, Deutschland






EU/1/18/1350


1.8.2023




26.7.2023


Xarelto







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/08/472


28.7.2023




28.7.2023


Clopidogrel/Acetylsalicylic acid Mylan







Mylan Pharmaceuticals Limited




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






EU/1/19/1395


31.7.2023




28.7.2023


Fluenz Tetra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/887


31.7.2023




28.7.2023


Mepsevii







Ultragenyx Germany GmbH




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






EU/1/18/1301


1.8.2023




28.7.2023


Ofev







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/979


3.8.2023




28.7.2023


Telzir







ViiV Healthcare BV




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






EU/1/04/282


31.7.2023




—   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




3.7.2023


Nobivac DP Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/20/265


5.7.2023




3.7.2023


Vaxxitek HVT + IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/02/032


6.7.2023




5.7.2023


Canigen L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/183


6.7.2023




5.7.2023


Forceris







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/19/235


7.7.2023




5.7.2023


Porcilis ColiClos







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/141


6.7.2023




17.7.2023


Strangvac







Intervacc AB




Vastertorpsvagen 135, 129 44 Hagersten, Sverige






EU/2/21/274


18.7.2023




26.7.2023


Equilis Prequenza







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/05/056


27.7.2023




26.7.2023


Equilis Prequenza Te







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/05/057


27.7.2023




26.7.2023


Equilis Te







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/05/055


27.7.2023




26.7.2023


Neptra







Bayer Animal Health GmbH




D-51368 Leverkusen, Deutschland






EU/2/19/246


28.7.2023




26.7.2023


Nobilis IB 4-91







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/98/006


28.7.2023




28.7.2023


PREVEXXION RN







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/254


31.7.2023




28.7.2023


Stelfonta







QBiotics Netherlands B.V.




Prinses Margrietplantsoen 33, 2595 AM Den Haag, Nederland






EU/2/19/248


10.8.2023




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.