法规知识库 · EMA 集中审评
Revlimid
lenalidomide · EMEA/H/C/000717 · 已授权
获批上市许可
2007-06-14
欧委会决定日
2025-06-05
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
25
官方索引 25
EPAR / 审评
22
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AX04
治疗领域：Multiple Myeloma;Lymphoma, Mantle-Cell;Myelodysplastic Syndromes
药理分类：Immunosuppressants
修订号：54 · 最新影响 PI 的程序：II/0130
适应症（原文）：Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphoma Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Follicular lymphoma Revlimid 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。
2025-06-05 · 欧委会决定
2007-06-14 · 获批上市许可
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
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Revlimid : EPAR - Risk Management Plan
rmp · 2025-09-09
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Revlimid : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-09-09
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Revlimid-H-C-PSR-S-0049 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-07-10
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Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2023-09-19
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Revlimid-H-C-PSUSA-00001838-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2021-12-15 · EMA/618753/2021
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Revlimid-H-C-PSUSA-00001838-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-11-03 · EMA/618753/2021
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Revlimid-H-C-PSUSA-00001838-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2020-10-09 · EMA/517770/2020
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Revlimid : Orphan designation withdrawal assessment report (post-authorisation)
orphan-maintenance-report-post · 2020-02-11 · EMADOC-2005359794-225433
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Revlimid-H-C-717-II-0107 : EPAR - Assessment Report - Variation
variation-report · 2020-01-15 · EMA/CHMP/693880/2019
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Revlimid : EPAR - Medicine overview
overview · 2020-01-15 · EMA/13848/2020
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Revlimid-H-C-717-II-0102-G: EPAR - Assessment Report - Variation
variation-report · 2019-06-11 · EMA/232212/2019
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Revlimid-H-C-PSUSA-00001838-201612 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-09-22 · EMA/627404/2017
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Revlimid-H-C-717-II-0089-G: EPAR - Assessment Report - Variation
variation-report · 2017-04-05
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Revlimid-H-C-PSUSA-1838-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-11-03 · EMA/551825/2016
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Revlimid-H-C-717-II-0079 : EPAR - Assessment Report - Variation
variation-report · 2016-07-18 · EMA/CHMP/642878/2015
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Revlimid-H-C-717-X-0073-G : EPAR - Assessment Report - Variation
variation-report · 2015-03-30 · EMA/130972/2015
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Revlimid-H-C-717-PSUV-0069 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-01-27 · EMA/39018/2014
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Revlimid-H-C-717-II-0056 : EPAR - Assessment Report - Variation
variation-report · 2013-07-19 · EMA/297642/2013
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Revlimid-H-C-717-X-0046-G : EPAR - Assessment Report - Extension
variation-report · 2012-10-10 · EMA/432817/2012
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Revlimid-H-C-717-A20-0048 : EPAR - Assessment Report - Article 20
variation-report · 2012-02-06 · EMA/862776/2011
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Revlimid : EPAR - Scientific Discussion
scientific-discussion · 2007-06-26
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Revlimid : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-06-26
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。