Transcription of Leqvio - 5333 - EPAR
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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 agents (C10AX) Therapeutic indication(s): treatment for
Non-alcoholic fatty liver disease . NASH . Non-alcoholic steatohepatitis . NCA . Non-compartmental analysis ... alone or in combination with other lipid -lowering therapies in patients who are statin -intolerant, ... Directive 2001/83/EC - complete and independent application . The application submitted is composed of administrative information ...
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