法规知识库 · EMA 集中审评
Nilemdo
bempedoic acid · EMEA/H/C/004958 · 已授权
获批上市许可
2020-04-01
欧委会决定日
2026-01-15
持有人 / 申请人
Daiichi Sankyo Europe GmbH
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:C10AX
治疗领域:Hypercholesterolemia;Dyslipidemias
药理分类:Lipid modifying agents
修订号:10 · 最新影响 PI 的程序:VR/0000286873
适应症(原文):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.
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2026-01-15 · 欧委会决定
2020-04-01 · 获批上市许可
2020-01-30 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。
EPAR / 审评资料
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Nilemdo : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-02-27
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Nilemdo : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-02-27
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Nilemdo : EPAR - Risk management plan
rmp · 2026-02-27
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Nilemdo-H-C-004958-II-0031 : EPAR - Assessment report - Variation
variation-report · 2024-06-20 · EMA/287787/2024
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Nilemdo : EPAR - Medicine overview
overview · 2024-06-20 · EMA/131272/2024
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Nilemdo : EPAR - Public assessment report
assessment-report · 2020-04-24 · EMA/CHMP/86202/2020
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。