法规知识库 · EMA 集中审评
Fingolimod Accord
fingolimod hydrochloride · EMEA/H/C/005191 · 已授权
获批上市许可
2020-06-25
欧委会决定日
2026-10-13
持有人 / 申请人
Accord Healthcare S.L.U.
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:L04AA27
治疗领域:Multiple Sclerosis, Relapsing-Remitting
药理分类:Immunosuppressants;Selective immunosuppressants
修订号:12 · 最新影响 PI 的程序:VR/0000379204
适应症(原文):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 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。
2026-10-13 · 欧委会决定
2020-06-25 · 获批上市许可
2020-04-30 · 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 ↗
Fingolimod Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-13
- 打开官方文件 ↗
Fingolimod Accord : EPAR - Risk management plan
rmp · 2026-03-02
- 打开官方文件 ↗
Fingolimod Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-11
- 打开官方文件 ↗
Fingolimod Accord : EPAR - Medicine overview
overview · 2020-07-03 · EMA/336317/2020
- 打开官方文件 ↗
Fingolimod Accord : EPAR - Public assessment report
assessment-report · 2020-07-03 · EMA/CHMP/267804/2020
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。