Leqvio - 5333 - EPAR

Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 15 October 2020 EMA/696912/2020 Committee for Medicinal Products for Human Use (CHMP) Assessment report Leqvio International non-proprietary name: inclisiran Procedure No. EMEA/H/C/005333/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/696912/2020 Page 2/143 Administrative information Name of the medicinal product: Leqvio applicant: Novartis Europharm Limited Vista Building Elm Park Merrion Road Dublin 4 IRELAND Active substance: INCLISIRAN International Non-proprietary Name/Common Name: inclisiran Pharmaco-therapeutic group (ATC Code): lipid modifying agents, plain, other lipid modifying ag

Liquid chromatography mass spectrometry . LDL : Low-density lipoprotein . LDL-C : Low-density lipoprotein cholesterol . LDLR : Low Density Lipoprotein Receptor . LLN : Lower limit of normal . LLOQ : Lower limit of quantitation . LMT : Lipid-modifying therapy . Lp(a) Lipoprotein (a) Lp-PLA2 : Lipoprotein-associated phospholipase A2 . LOESS

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