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法规知识库 · EMA 集中审评

Repatha

Evolocumab · EMEA/H/C/003766 · 已授权

获批上市许可

2015-07-17

欧委会决定日

2026-08-21

持有人 / 申请人

Amgen Europe B.V.

终止日期字段

无

从产品到官方文件

文件记录

12

官方索引 12

EPAR / 审评

10

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:C10AX13

治疗领域:Dyslipidemias;Hypercholesterolemia

药理分类:Lipid modifying agents

修订号:28 · 最新影响 PI 的程序:VR/0000322435

适应症(原文):Hypercholesterolaemia and mixed dyslipidaemia Repatha 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 or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies 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. 2026-08-21 · 欧委会决定

  2. 2015-07-17 · 获批上市许可

  3. 2015-05-20 · 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 10产品信息 2其他 0

EPAR / 审评资料

  • Repatha : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-09-04

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  • Repatha : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-12-15

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  • Repatha : EPAR - Risk-management-plan summary

    rmp-summary · 2024-09-06

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  • Repatha: EPAR - Paediatric investigation plan compliance statement

    pip-compliance · 2023-01-23 · EMA/690314/2022

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  • Repatha-H-C-3766-II-0049-G : EPAR - Assessment Report - Variation

    variation-report · 2022-01-05 · EMA/CHMP/572365/2021

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  • Repatha : EPAR - Medicine overview

    overview · 2022-01-05 · EMA/5899/2022

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  • Repatha-H-C-PSUSA-00010405-202007 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2021-04-29 · EMA/241723/2021

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  • Repatha-H-C-3766-II-0017-G : EPAR - Assessment Report - Variation

    variation-report · 2018-05-29 · EMA/233126/2018

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  • Repatha-H-C-3766-X-0002 : EPAR - Assessment Report - Variation

    variation-report · 2017-03-03 · EMA/140771/2017

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  • Repatha : EPAR - Public assessment report

    assessment-report · 2015-08-03 · EMA/CHMP/222019/2015

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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。