Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2023 to 28 February 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: 2023-03-31
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_2023118EN.01000101.xml










31.3.2023   


EN


Official Journal of the European Union


C 118/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2023 to 28 February 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 118/01)
—   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




15.2.2023


Dimethyl Fumarate Accord


dimethyl fumarate







Accord Healthcare S.L.U.




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






EU/1/22/1711


Gastro-resistant capsule, hard


L04AX07


17.2.2023




20.2.2023


Hemgenix


etranacogene dezaparvovec







CSL Behring GmbH




D-35041 Marburg, Deutschland






EU/1/22/1715


Concentrate for solution for infusion


B06


23.2.2023




20.2.2023


IMJUDO


tremelimumab







AstraZeneca AB




Forskargatan 18, 151 85 Södertälje, Sverige






EU/1/22/1713


Concentrate for solution for infusion


L01FX20


23.2.2023




20.2.2023


Tremelimumab AstraZeneca


tremelimumab







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1712


Concentrate for solution for infusion


L01FX20


21.2.2023




24.2.2023


Paxlovid


Nirmatrelvir / ritonavir







Pfizer Europe MA EEIG




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






EU/1/22/1625


Film-coated tablet


J05AE30


27.2.2023




—   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




3.2.2023


Ambirix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/02/224


6.2.2023




3.2.2023


Bortezomib Hospira







Pfizer Europe MA EEIG




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






EU/1/16/1114


6.2.2023




3.2.2023


Copiktra







Secura Bio Limited




32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland






EU/1/21/1542


17.2.2023




3.2.2023


Darunavir Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1140


7.2.2023




3.2.2023


EVOTAZ







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1025


6.2.2023




3.2.2023


Forxiga







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/795


6.2.2023




3.2.2023


Glivec







Novartis Europharm Limited




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






EU/1/01/198


7.2.2023




3.2.2023


HALAVEN







Eisai GmbH




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






EU/1/11/678


8.2.2023




3.2.2023


Infanrix hexa







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/00/152


17.2.2023




3.2.2023


Invanz







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/02/216


9.2.2023




3.2.2023


KANJINTI







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/18/1281


6.2.2023




3.2.2023


Levetiracetam Accord







Accord Healthcare S.L.U.




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






EU/1/11/712


6.2.2023




3.2.2023


Nimvastid







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/525


14.2.2023




3.2.2023


NULIBRY







Zydus France S.A.S.




Zac Les Hautes Patures, 25 Rue Des Peupliers, 92000 Nanterre, France






EU/1/22/1684


9.2.2023




3.2.2023


Orencia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/389


6.2.2023




3.2.2023


Pemetrexed Accord







Accord Healthcare S.L.U.




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






EU/1/15/1071


7.2.2023




3.2.2023


Quofenix







A. Menarini — Industrie Farmaceutiche Riunite — s.r.l.




Via Sette Santi 3, 50131 Florence, Italia






EU/1/19/1393


8.2.2023




3.2.2023


Rasilez







Noden Pharma DAC




D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland






EU/1/07/405


13.2.2023




3.2.2023


Rixubis







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/14/970


9.2.2023




3.2.2023


SCENESSE







Clinuvel Europe Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/14/969


7.2.2023




3.2.2023


Sivextro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/991


6.2.2023




3.2.2023


TRISENOX







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/02/204


7.2.2023




3.2.2023


Xagrid







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/04/295


6.2.2023




3.2.2023


Xigduo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/900


6.2.2023




6.2.2023


Ebvallo







Pierre Fabre Medicament




Les Cauquillous, 81500 Lavaur, France






EU/1/22/1700


7.2.2023




6.2.2023


Ebymect







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1051


7.2.2023




6.2.2023


Hefiya







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1287


7.2.2023




6.2.2023


Kerendia







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/21/1616


7.2.2023




6.2.2023


Tivicay







ViiV Healthcare BV




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






EU/1/13/892


7.2.2023




6.2.2023


Xromi







Nova Laboratories Ireland Limited




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






EU/1/19/1366


13.2.2023




9.2.2023


AMGLIDIA







AMMTeK




55 rue de Turbigo, 75003 Paris, France






EU/1/18/1279


14.2.2023




9.2.2023


Brukinsa







BeiGene Ireland Limited




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






EU/1/21/1576


10.2.2023




9.2.2023


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


13.2.2023




15.2.2023


ASPAVELI







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/21/1595


17.2.2023




15.2.2023


Fulphila







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1329


16.2.2023




15.2.2023


Hyrimoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1286


20.2.2023




15.2.2023


JEMPERLI







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1538


20.2.2023




15.2.2023


Lokelma







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1173


16.2.2023




15.2.2023


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


16.2.2023




15.2.2023


Pemetrexed Krka







KRKA, d.d.




Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/18/1283


20.2.2023




15.2.2023


Pregabalin Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1011


6.3.2023




15.2.2023


Semglee







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1270


16.2.2023




15.2.2023


Trodelvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/21/1592


16.2.2023




15.2.2023


Vyndaqel







Pfizer Europe MA EEIG




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






EU/1/11/717


16.2.2023




15.2.2023


Zonegran







Amdipharm Limited




3 Burlington Road, Dublin 4, D04 RD68, IRELAND






EU/1/04/307


21.2.2023




20.2.2023


Aimovig







Novartis Europharm Limited




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






EU/1/18/1293


22.2.2023




20.2.2023


Calquence







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1479


21.2.2023




20.2.2023


Tractocile







Ferring Pharmaceuticals A/S




Amager Strandvej 405, 2770 Kastrup, Danmark






EU/1/99/124


3.3.2023




20.2.2023


Triumeq







ViiV Healthcare BV




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






EU/1/14/940


21.2.2023




20.2.2023


Yuflyma







Celltrion Healthcare Hungary Kft.




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






EU/1/20/1513


21.2.2023




23.2.2023


Atosiban SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/13/852


27.2.2023




23.2.2023


Gilenya







Novartis Europharm Limited




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






EU/1/11/677


24.2.2023




23.2.2023


Ivabradine Accord







Accord Healthcare S.L.U.




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






EU/1/17/1190


24.2.2023




23.2.2023


Kinzalmono







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/98/091


24.2.2023




23.2.2023


Micardis







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/98/090


2.3.2023




23.2.2023


Nimenrix







Pfizer Europe MA EEIG




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






EU/1/12/767


24.2.2023




23.2.2023


Pemazyre







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1535


24.2.2023




24.2.2023


Adcirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/08/476


27.2.2023




24.2.2023


Emselex







zr pharma& GmbH




Hietzinger Hauptstrasse 37, 1130 Wien, Österreich






EU/1/04/294


1.3.2023




24.2.2023


Febuxostat Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1194


27.2.2023




24.2.2023


Pemazyre







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1535


27.2.2023




24.2.2023


QINLOCK







Deciphera Pharmaceuticals (Netherlands) B.V.




Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland






EU/1/21/1569


3.3.2023




24.2.2023


Rixathon







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1185


27.2.2023




24.2.2023


Riximyo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1184


27.2.2023




24.2.2023


Ronapreve







Roche Registration GmbH




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






EU/1/21/1601


28.2.2023




24.2.2023


TUKYSA







Seagen B.V.




Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland






EU/1/20/1526


2.3.2023




24.2.2023


Wakix







Bioprojet Pharma




9 rue Rameau, 75002 Paris, France






EU/1/15/1068


27.2.2023




27.2.2023


Abilify







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/04/276


7.3.2023




27.2.2023


Aflunov







Seqirus S.r.l.




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






EU/1/10/658


28.2.2023




27.2.2023


Daptomycin Hospira







Pfizer Europe MA EEIG




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






EU/1/17/1175


28.2.2023




27.2.2023


Foclivia







Seqirus S.r.l.,




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






EU/1/09/577


28.2.2023




27.2.2023


NUBEQA







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/20/1432


28.2.2023




27.2.2023


Reblozyl







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1452


28.2.2023




27.2.2023


Reblozyl







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1452


28.2.2023




27.2.2023


Sprycel







Bristol-Myers Squibb Pharma EEIG




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






EU/1/06/363


28.2.2023




27.2.2023


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


28.2.2023




27.2.2023


Venclyxto







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/16/1138


28.2.2023




27.2.2023


Voriconazole Accord







Accord Healthcare S.L.U.




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






EU/1/13/835


28.2.2023




—   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




23.2.2023


Pregabalin Zentiva k.s







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1166


24.2.2023




—   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




2.2.2023


Tulissin







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/20/252


6.2.2023




3.2.2023


Forceris







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/19/235


6.2.2023




3.2.2023


Locatim







Biokema Europe




Centre des Affaires des Lilas, 77 Avenue des Lilas, 64000 Pau, France






EU/2/99/011


9.2.2023




3.2.2023


Panacur AquaSol







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/135


7.2.2023




6.2.2023


Apoquel







Zoetis Belgium




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






EU/2/13/154


7.2.2023




6.2.2023


CLYNAV







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/197


7.2.2023




6.2.2023


Procox







VETOQUINOL S.A.




Magny-Vernois, 70200 Lure, France






EU/2/11/123


8.2.2023




6.2.2023


Procox







VETOQUINOL S.A.




Magny-Vernois, 70200 Lure, France






EU/2/11/123


7.2.2023




6.2.2023


Versican Plus DHPPi/L4R







Zoetis Belgium




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






EU/2/14/163


7.2.2023




9.2.2023


MiPet Easecto







Zoetis Belgium




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






EU/2/17/220


14.2.2023




20.2.2023


Advocate







Bayer Animal Health GmbH




D-51368 Leverkusen, Deutschland






EU/2/03/039


22.2.2023




20.2.2023


Bovela







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/14/176


22.2.2023




20.2.2023


GALLIPRANT







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/221


21.2.2023




20.2.2023


Suvaxyn Circo + MH RTU







Zoetis Belgium SA




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






EU/2/15/190


23.2.2023




23.2.2023


Locatim







Biokema Europe




Centre des Affaires des Lilas, 77 Avenue des Lilas, 64000 Pau, France






EU/2/99/011


1.3.2023




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.