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AkdÄ2023EN

AkdÄ: Bempedoinsäure: Fallbericht einer Achillessehnenruptur

Zusammenfassung

30 January 2020 Committee for Medicinal Products for Human Use (CHMP) Nilemdo International non-proprietary name: bempedoic acid Procedure No. EMEA/H/C/004958/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone

Kerninformationen

GERMANY Active substance: BEMPEDOIC ACID International Non-proprietary Name/Common Name: Pharmaco-therapeutic group Lipid modifying agents, other lipid modifying agents (ATC Code): (C10AX15) Therapeutic indication(s): Nilemdo is indicated in adults with primary hypercholesterolaemia (heter...
Strength(s): Route(s) of administration: Oral use Packaging: blister (PVC/alu) Package size(s): 10 tablets, 28 tablets, 30 tablets, 90 tablets, 98 tablets and 100 tablets Table of contents 1. Background information on the procedure .............................................. 8 1.1. Submiss...
tion ......................................................................................... 10 2.1.2. Epidemiology and risk factors, screening tools/prevention .................................... 10 2.1.3. Biologic features. Aetiology and pathogenesis. ..............................................
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