法规知识库 · EMA 集中审评
Leflunomide medac
leflunomide · EMEA/H/C/001227 · 已授权
获批上市许可
2010-07-27
欧委会决定日
2026-07-31
持有人 / 申请人
medac Gesellschaft für klinische Spezialpräparate mbH
终止日期字段
无
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
8
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AK01
治疗领域：Arthritis, Rheumatoid
药理分类：Selective immunosuppressants
修订号：26 · 最新影响 PI 的程序：VR/0000361880
适应症（原文）：Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
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。
2026-07-31 · 欧委会决定
2010-07-27 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Leflunomide medac : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-04
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Leflunomide medac : EPAR - Risk management plan
rmp · 2025-07-04
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Leflunomide medac : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-04
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Leflunomide medac-H-C-PSUSA-00001837-202309 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-07-30 · EMA/352161/2024
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Leflunomide medac : EPAR - Summary for the public
overview · 2014-08-12
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Leflunomide medac-H-C-1227-X-0012-G : EPAR - Assessment Report - Extension
variation-report · 2013-10-08 · EMA/CHMP/478482/2013
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Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2010-08-05
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Leflunomide medac : EPAR - Public assessment report
assessment-report · 2010-08-05
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。