法规知识库 · EMA 集中审评
Procoralan
ivabradine hydrochloride · EMEA/H/C/000597 · 已授权
获批上市许可
2005-10-25
欧委会决定日
2025-11-13
持有人 / 申请人
Les Laboratoires Servier
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
13
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：C01EB17
治疗领域：Angina Pectoris;Heart Failure
药理分类：Cardiac therapy
修订号：24 · 最新影响 PI 的程序：VR/0000286236
适应症（原文）：Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated : in adults unable to tolerate or with a contraindication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
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。
2025-11-13 · 欧委会决定
2005-10-25 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Procoralan : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-17
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Procoralan : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-17
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Procoralan : EPAR - Risk-management-plan summary
rmp-summary · 2023-12-21
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Procoralan : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2023-12-21
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Procoralan-H-C-N-PSR-S-0019 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2019-02-26 · EMA/798331/2018
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Procoralan : EPAR - Summary for the public
overview · 2019-02-26
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Procoralan : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2015-05-07 · EMA/285905/2015
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Procoralan-H-C-597-A20-1404 : EPAR - Assessment Report - Article 20
variation-report · 2015-02-10 · EMA/734305/2014
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Procoralan : EPAR - Scientific Conclusion
scientific-conclusion · 2015-02-10
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Procoralan-H-C-597-PSUV-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-09-11 · EMA/373632/2014
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Procoralan-H-C-597-II-0029 : EPAR - Assessment Report - Variation
variation-report · 2014-03-19 · EMA/696794/2013
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Procoralan-H-C-597-II-0018 : EPAR - Assessment Report - Variation
variation-report · 2012-03-27 · EMA/194513/2012
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Procoralan : EPAR - Scientific Discussion
scientific-discussion · 2005-11-04
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。