法规知识库 · EMA 集中审评
Sifrol
pramipexole · EMEA/H/C/000133 · 已授权
获批上市许可
1997-10-13
欧委会决定日
2026-06-23
持有人 / 申请人
Boehringer Ingelheim International GmbH
终止日期字段
无
从产品到官方文件
文件记录
18
官方索引 18
EPAR / 审评
16
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：N04BC05
治疗领域：Restless Legs Syndrome;Parkinson Disease
药理分类：Anti-Parkinson drugs
修订号：40 · 最新影响 PI 的程序：N/0000357284
适应症（原文）：Sifrol is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, though to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).
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。
2026-06-23 · 欧委会决定
1997-10-13 · 获批上市许可
1997-06-18 · 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
- 打开官方文件 ↗
Sifrol : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-30
- 打开官方文件 ↗
Sifrol : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-06-30
- 打开官方文件 ↗
Sifrol-H-C-PSUSA-00002491-202304 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-01-24 · EMA/37077/2024
- 打开官方文件 ↗
Sifrol-H-C-PSUSA-00002491-201904 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2020-03-26 · EMA/155423/2020
- 打开官方文件 ↗
Sifrol : EPAR - Risk-management-plan summary
rmp-summary · 2019-05-20
- 打开官方文件 ↗
Sifrol : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2018-03-22
- 打开官方文件 ↗
Sifrol-H-C-PSUSA-00002491-201604 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2017-03-01 · EMA/CHMP/17308/2017
- 打开官方文件 ↗
Sifrol-H-C-133-PSUSA-2491-201304 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-03-24 · EMA/157197/2014
- 打开官方文件 ↗
Sifrol-H-C-133-P46-0040 : EPAR - Assessment Report
variation-report · 2013-04-22 · EMA/161985/2013
- 打开官方文件 ↗
Sifrol : EPAR - Summary for the public
overview · 2011-01-05
- 打开官方文件 ↗
Sifrol-H-C-133-X-0054 : EPAR - Assessment Report - Extension
variation-report · 2010-07-12
- 打开官方文件 ↗
Sifrol-H-C-133-X-0051 : EPAR - Assessment Report - Extension
variation-report · 2009-11-17 · EMEA/703892/2009
- 打开官方文件 ↗
Sifrol-H-C-133-II-0030 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-09-12
- 打开官方文件 ↗
Sifrol : EPAR - Scientific Discussion
scientific-discussion · 2005-10-26
- 打开官方文件 ↗
Sifrol : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-10-26
- 打开官方文件 ↗
Sifrol : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-26
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。