法规知识库 · EMA 集中审评
Lenalidomide Mylan
lenalidomide · EMEA/H/C/005306 · 已授权
获批上市许可
2020-12-18
欧委会决定日
2026-06-08
持有人 / 申请人
Mylan Pharmaceuticals Limited
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
8
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AX07
治疗领域：Multiple Myeloma
药理分类：Immunosuppressants
修订号：14 · 最新影响 PI 的程序：VR/0000326802
适应症（原文）：Multiple myeloma Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphoma Lenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).
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。
2026-06-08 · 欧委会决定
2020-12-18 · 获批上市许可
2020-10-15 · 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 ↗
Lenalidomide Mylan : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-12
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Lenalidomide Mylan : EPAR - Risk-management-plan
rmp-summary · 2026-05-11
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Lenalidomide Mylan : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-05
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Lenalidomide Mylan-H-C-PSUSA-00001838-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-05-31 · EMA/618753/2021
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Lenalidomide Mylan-H-C-PSUSA-00001838-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-03-31 · EMA/618753/2021
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Lenalidomide Mylan : EPAR - Medicine overview
overview · 2021-01-07 · EMA/563897/2020
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Lenalidomide Mylan : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2021-01-07
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Lenalidomide Mylan : EPAR - Public assessment report
assessment-report · 2021-01-07 · EMA/CHMP/583241/2020
产品信息
- 打开官方文件 ↗
Lenalidomide Mylan : EPAR - Product information - tracked changes
product-information-tracked-changes · 2026-06-12
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Lenalidomide Mylan : EPAR - Product information
product-information · 2026-06-12
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Lenalidomide Mylan : EPAR - All authorised presentations
all-authorised-presentations · 2021-07-26
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。