法规知识库 · EMA 集中审评
Lemtrada
alemtuzumab · EMEA/H/C/003718 · 已授权
获批上市许可
2013-09-12
欧委会决定日
2025-09-17
持有人 / 申请人
Sanofi Belgium
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
17
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AA34
治疗领域：Multiple Sclerosis
药理分类：Selective immunosuppressants
修订号：28 · 最新影响 PI 的程序：VR/0000335041
适应症（原文）：Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
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。
2025-09-17 · 欧委会决定
2013-09-12 · 获批上市许可
2013-06-27 · 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 ↗
Lemtrada-VR-0000335041 : EPAR - Assessment report - Variation
variation-report · 2026-10-30 · EMADOC-1700519818-3008971
- 打开官方文件 ↗
Lemtrada : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-30
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Lemtrada : EPAR - Risk management plan
rmp · 2026-10-30
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Lemtrada-H-C-003718-PSR-S-0050 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-10-21 · EMA/338122/2025
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Lemtrada-H-C-003718-PSR-S-0051 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-10-21 · EMA/338170/2025
- 打开官方文件 ↗
Lemtrada : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-21
- 打开官方文件 ↗
Lemtrada : EPAR - Risk-management-plan summary
rmp-summary · 2022-07-19
- 打开官方文件 ↗
Lemtrada-H-C-PSUSA-00010055-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-06-29 · EMA/363703/2021
- 打开官方文件 ↗
Lemtrada-H-C-PSUSA-00010055-201909 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-07-21 · EMA/330193/2020
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Lemtrada Article 20 referral - Scientific conclusions
scientific-conclusion · 2020-01-29
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Lemtrada : EPAR - Medicine overview
overview · 2020-01-29 · EMA/653536/2019
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Lemtrada-H-C-PSUSA-00010055-201809 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation - Provisional measures
scientific-conclusion · 2019-06-05 · EMA/CHMP/287682/2019
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Lemtrada Article 20 referral - Assessment report on provisional measures
variation-report · 2019-05-08 · EMA/249094/2019
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Lemtrada Article 20 referral - Scientific conclusions on provisional measures
scientific-conclusion · 2019-05-08
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Lemtrada-H-C-PSUSA-00010055-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-02-08 · EMA/CHMP/79804/2018
- 打开官方文件 ↗
Lemtrada-H-C-PSUSA-00010055-201509: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-07-07 · EMA/CHMP/296595/2016
- 打开官方文件 ↗
Lemtrada : EPAR - Public assessment report
assessment-report · 2013-09-25 · EMA/563018/2013
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。