欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Nustendi
适用类别Human
治疗领域Hypercholesterolemia;Dyslipidemias
通用名/非专利名称bempedoic acid;ezetimibe
活性成分bempedoic acid;ezetimibe
产品号EMEA/H/C/004959
患者安全信息No
许可状态Authorised
ATC编码C10B
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2020/03/27
上市许可开发者/申请人/持有人Daiichi Sankyo Europe GmbH
人用药物治疗学分组Lipid modifying agents
兽用药物治疗学分组
审评意见日期2020/01/30
欧盟委员会决定日期2025/05/08
修订号8
治疗适应症Hypercholesterolaemia and mixed dyslipidaemiaNustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statinCardiovascular diseaseNustendi is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:• in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,• in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or, • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
适用物种
兽用药物ATC编码
首次发布日期2020/04/24
最后更新日期2025/06/23
产品说明书https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/nustendi
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase