Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2022 to 31 August 2022 (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: 2022-09-30
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_2022376EN.01000101.xml










30.9.2022   


EN


Official Journal of the European Union


C 376/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2022 to 31 August 2022
(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))
(2022/C 376/01)
—   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




8.8.2022


Veklury


remdesivir







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


Concentrate for solution for infusion
Powder for concentrate for solution for infusion


J05AB16


8.8.2022




10.8.2022


Vyvgart


efgartigimod alfa







argenx BV




Industriepark-Zwijnaarde 7, 9052 Gent, België






EU/1/22/1674


Concentrate for solution for infusion


L04AA58


11.8.2022




17.8.2022


Pepaxti


melphalan flufenamide







Oncopeptides AB (publ)




Västra Trädgårdsgatan 15, 111 53 Stockholm, Sverige






EU/1/22/1669


Powder for concentrate for solution for infusion


L01AA10


18.8.2022




17.8.2022


RAYVOW


lasmiditan







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/21/1587


Film-coated tablet


N02CC


19.8.2022




17.8.2022


Sunlenca


lenacapavir







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/22/1671


Film-coated tablet
Solution for injection


J05AX31


19.8.2022




17.8.2022


VEGZELMA


bevacizumab







Celltrion Healthcare Hungary Kft.




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






EU/1/22/1667


Concentrate for solution for infusion


L01XC07


18.8.2022




23.8.2022


TECVAYLI


teclistamab







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1675


Solution for injection


L01F


24.8.2022




24.8.2022


Roctavian


valoctocogene roxaparvovec







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/22/1668


Solution for infusion


Pending


25.8.2022




25.8.2022


Ranivisio


ranibizumab







Midas Pharma GmbH




Rheinstraße 49, D-55218 Ingelheim, Deutschland






EU/1/22/1673


Solution for injection


S01LA04


26.8.2022




25.8.2022


Scemblix


asciminib







Novartis Europharm Limited




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






EU/1/22/1670


Film-coated tablet


L01EA06


26.8.2022




—   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




2.8.2022


Alecensa







Roche Registration GmbH




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






EU/1/16/1169


4.8.2022




2.8.2022


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


3.8.2022




2.8.2022


Lynparza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/959


3.8.2022




2.8.2022


Neofordex







Laboratoires CTRS




63 rue de l'Est, 92100 Boulogne-Billancourt, France






EU/1/15/1053


24.8.2022




2.8.2022


Prialt







Esteve Pharmaceuticals GmbH




Hohenzollerndamm 150-151, 14199 Berlin, Deutschland






EU/1/04/302


3.8.2022




2.8.2022


Vaxchora







Emergent Netherlands B.V.




Strawinskylaan 411, 1077 XX Amsterdam, Nederland






EU/1/20/1423


8.8.2022




5.8.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


5.8.2022




5.8.2022


Synagis







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/99/117


9.8.2022




5.8.2022


Tacforius







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/17/1244


9.8.2022




5.8.2022


Xermelo







SERB SAS




40 Avenue George V, 75008 Paris, France






EU/1/17/1224


11.8.2022




8.8.2022


Fasenra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1252


9.8.2022




8.8.2022


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


8.8.2022




12.8.2022


Arava







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/99/118


19.8.2022




12.8.2022


Bortezomib SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/16/1102


22.8.2022




12.8.2022


Brintellix







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/13/891


29.8.2022




12.8.2022


Effentora







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/441


16.8.2022




12.8.2022


Genvoya







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/15/1061


16.8.2022




12.8.2022


Lenalidomide Krka d.d. Novo mesto







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1520


6.9.2022




12.8.2022


NexoBrid







MediWound Germany GmbH




Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland






EU/1/12/803


16.8.2022




12.8.2022


Sustiva







Bristol-Myers Squibb Pharma EEIG




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






EU/1/99/110


16.8.2022




12.8.2022


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/508


1.9.2022




16.8.2022


Spikevax







MODERNA BIOTECH SPAIN, S.L.




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






EU/1/20/1507


22.8.2022




17.8.2022


Blitzima







Celltrion Healthcare Hungary Kft.




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






EU/1/17/1205


18.8.2022




17.8.2022


Cuprior







Orphalan




226 Boulevard Voltaire, 75011 Paris, France






EU/1/17/1199


24.8.2022




17.8.2022


Fetcroja







Shionogi B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Nederland






EU/1/20/1434


24.8.2022




17.8.2022


Mabthera







Roche Registration GmbH




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






EU/1/98/067


18.8.2022




17.8.2022


Piqray







Novartis Europharm Limited




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






EU/1/20/1455


18.8.2022




17.8.2022


Procysbi







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/13/861


18.8.2022




17.8.2022


Rixathon







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1185


22.8.2022




17.8.2022


Riximyo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1184


22.8.2022




17.8.2022


Vemlidy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1154


19.8.2022




22.8.2022


Granupas







Eurocept International B.V.




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/13/896


5.9.2022




22.8.2022


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


23.8.2022




22.8.2022


Onivyde pegylated liposomal







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/16/1130


23.8.2022




22.8.2022


Ritonavir Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1242


23.8.2022




22.8.2022


Suliqua







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/16/1157


23.8.2022




24.8.2022


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


25.8.2022




24.8.2022


Lacosamide Accord







Accord Healthcare S.L.U.




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






EU/1/17/1230


25.8.2022




24.8.2022


PREVYMIS







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/17/1245


5.9.2022




24.8.2022


Ruxience







Pfizer Europe MA EEIG




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






EU/1/20/1431


25.8.2022




25.8.2022


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


30.8.2022




25.8.2022


Exjade







Novartis Europharm Limited




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






EU/1/06/356


26.8.2022




25.8.2022


Myozyme







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/333


29.8.2022




25.8.2022


VITRAKVI







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/19/1385


30.8.2022




25.8.2022


Zolgensma







Novartis Europharm Limited




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






EU/1/20/1443


26.8.2022




—   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




5.8.2022


Zalviso







FGK Representative Service GmbH




Heimeranstraße 35, 80339 München, Deutschland






EU/1/15/1042


9.8.2022




—   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




12.8.2022


Coxatab


firocoxib







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/22/286


Chewable tablet


QM01AH90


16.8.2022




—   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




2.8.2022


Bravecto







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/158


3.8.2022




5.8.2022


Credelio







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/206


8.8.2022




5.8.2022


Meloxidyl







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/06/070


8.8.2022




5.8.2022


Solensia







Zoetis Belgium SA




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






EU/2/20/269


8.8.2022




12.8.2022


NexGard







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/13/159


16.8.2022




12.8.2022


Prevomax







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/17/211


17.8.2022




19.8.2022


LETIFEND







LETI Pharma, S.L.U.




C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760 Madrid, España






EU/2/16/195


30.8.2022




25.8.2022


Porcilis PCV ID







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/187


1.9.2022




26.8.2022


GUMBOHATCH







Laboratorios Hipra, S.A.




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






EU/2/19/245


29.8.2022




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.