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法规知识库 · EMA 集中审评

Praluent

alirocumab · EMEA/H/C/003882 · 已授权

获批上市许可

2015-09-23

欧委会决定日

2025-10-17

持有人 / 申请人

Sanofi Winthrop Industrie

终止日期字段

无

从产品到官方文件

文件记录

11

官方索引 11

EPAR / 审评

9

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:C10AX14

治疗领域:Dyslipidemias

药理分类:Lipid modifying agents

修订号:26 · 最新影响 PI 的程序:VR/0000295839

适应症(原文):Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) 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. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular 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. 2025-10-17 · 欧委会决定

  2. 2015-09-23 · 获批上市许可

  3. 2015-07-23 · CHMP 意见通过

说明书、EPAR 与其他文件

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EPAR / 审评资料 9产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-01-09

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

    procedural-steps-after · 2025-10-21

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  • Praluent-H-C-3882-II-0078 : EPAR - Assessment report - Variation

    variation-report · 2024-01-04 · EMA/529151/2023

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  • Praluent : EPAR - Risk-management-plan summary

    rmp-summary · 2024-01-04

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  • Praluent : EPAR - Medicine overview

    overview · 2024-01-04 · EMA/529154/2023

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  • Praluent-H-C-3882-X-0054-G : EPAR - Assessment report - Variation

    variation-report · 2021-03-01 · EMA/379767/2020

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  • Praluent-H-C-3882-II-0053 : EPAR - Assessment report - Variation

    variation-report · 2020-06-18 · EMA/330215/2020

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  • Praluent-H-C-3882-II-0042 : EPAR - Assessment report - Variation

    variation-report · 2019-08-13 · EMA/152718/2019

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  • Praluent : EPAR - Public assessment report

    assessment-report · 2015-10-01 · EMA/CHMP/392430/2015

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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。