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。
2026-08-21 · 欧委会决定
2015-07-17 · 获批上市许可
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
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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
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。