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法规知识库 · EMA 集中审评

Riluzole Zentiva

riluzole · EMEA/H/C/002622 · 已授权

获批上市许可

2012-05-07

欧委会决定日

2025-05-15

持有人 / 申请人

Zentiva k.s.

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:N07XX02

治疗领域:Amyotrophic Lateral Sclerosis

药理分类:Other nervous system drugs

修订号:14 · 最新影响 PI 的程序:N/0000269434

适应症(原文):Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.

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. 2025-05-15 · 欧委会决定

  2. 2012-05-07 · 获批上市许可

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 5产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2025-05-15

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

    procedural-steps-after · 2025-05-15

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  • Riluzole Zentiva-H-C-PSUSA-00002645-202112 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

    scientific-conclusion · 2022-11-22 · EMA/732027/2022

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  • Riluzole Zentiva : EPAR - Public assessment report

    assessment-report · 2012-05-23 · EMA/241210/2012

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  • Riluzole Zentiva : EPAR - Summary for the public

    overview · 2012-05-23 · EMA/300585/2012

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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。