法规知识库 · EMA 集中审评
Gilenya
fingolimod hydrochloride · EMEA/H/C/002202 · 已授权
获批上市许可
2011-03-17
欧委会决定日
2026-09-28
持有人 / 申请人
Novartis Europharm Limited
终止日期字段
无
从产品到官方文件
文件记录
23
官方索引 23
EPAR / 审评
20
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AE01
治疗领域：Multiple Sclerosis
药理分类：Immunosuppressants
修订号：43 · 最新影响 PI 的程序：VR/0000372645
适应症（原文）：Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
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。
2026-09-28 · 欧委会决定
2011-03-17 · 获批上市许可
2011-01-20 · 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
- 打开官方文件 ↗
Gilenya : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-29
- 打开官方文件 ↗
Gilenya-PAM-0000295236 : EPAR - Assessment report
variation-report · 2025-12-02 · EMADOC-1700519818-2443340
- 打开官方文件 ↗
Gilenya : EPAR - Risk Management Plan
rmp · 2025-09-23
- 打开官方文件 ↗
Gilenya : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-23
- 打开官方文件 ↗
Gilenya-H-C-2202-P46-039 : EPAR - Assessment Report
variation-report · 2021-12-06 · EMA/CHMP/716292/2021
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Gilenya-H-C-PSUSA-00001393-202002: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-12-18 · EMA/601114/2020
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Gilenya-H-C-PSUSA-00001393-201902 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-12-20 · EMA/601061/2019
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Gilenya-H-C-2202-X-0044-G : EPAR - Assessment Report - Variation
variation-report · 2019-02-19 · EMA/779102/2018
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Gilenya-H-C-PSUSA-00001393-201802 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-12-18
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Gilenya : EPAR - Medicine overview
overview · 2018-12-18 · EMA/685570/2018
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Gilenya-H-C-PSUSA-00001393-201702 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-02-12
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Gilenya-H-C-PSUSA-00001393-201602 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-12-21 · EMA/879483/2016
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Gilenya-H-C-PSUSA-00001393-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-03-07 · EMA/699354/2015
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Gilenya-H-C-2202-II-0034 : EPAR - Assessment Report - Variation
variation-report · 2015-12-17 · EMA/CHMP/549382/2015
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Gilenya-H-C-PSUV-0027 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-07-11 · EMA/405985/2014
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Gilenya-H-C-2202-II-0021 : EPAR - Assessment Report - Variation
variation-report · 2014-06-27 · EMA/195551/2014
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Gilenya-H-C-2202-PSUV-0023 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-04-01 · EMA/177651/2014
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Gilenya-H-C-2202-A20-0008 : EPAR - Assessment Report - Article 20
variation-report · 2012-07-06 · EMA/357270/2012
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Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2012-07-06
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Gilenya : EPAR - Public assessment report
assessment-report · 2011-03-30 · EMA/108602/2011
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。