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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。

  1. 2026-01-15 · 欧委会决定

  2. 2020-04-01 · 获批上市许可

  3. 2020-01-30 · CHMP 意见通过

说明书、EPAR 与其他文件

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EPAR / 审评资料 6产品信息 2其他 0

EPAR / 审评资料

  • 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

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产品信息

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。