欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Nilemdo
适用类别Human
治疗领域Hypercholesterolemia;Dyslipidemias
通用名/非专利名称bempedoic acid
活性成分bempedoic acid
产品号EMEA/H/C/004958
患者安全信息No
许可状态Authorised
ATC编码C10AX
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2020/04/01
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9
治疗适应症Hypercholesterolaemia and mixed dyslipidaemiaNilemdo 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 or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.Cardiovascular diseaseNilemdo 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 with or without ezetimibe or,• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.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/nilemdo-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/nilemdo
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