法规知识库 · EMA 集中审评
Arava
leflunomide · EMEA/H/C/000235 · 已授权
获批上市许可
1999-09-02
欧委会决定日
2026-07-23
持有人 / 申请人
Sanofi-aventis Deutschland GmbH
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
9
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AK01
治疗领域：Arthritis, Rheumatoid;Arthritis, Psoriatic
药理分类：Immunosuppressants
修订号：46 · 最新影响 PI 的程序：VR/0000327001
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); active psoriatic arthritis. 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。
2026-07-23 · 欧委会决定
1999-09-02 · 获批上市许可
1999-05-20 · 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
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Arava : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-07
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Arava : EPAR - Risk Management Plan
rmp-summary · 2026-05-08
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Arava : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-17
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Arava-H-C-PSUSA-00001837-202309 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-09-05 · EMA/356172/2024
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Arava : EPAR - Summary for the public
overview · 2015-06-29 · EMA/262370/2011
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Arava-H-C-235-II-0028: EPAR - Assessment Report - Variation
variation-report · 2012-04-03 · EMA/215936/2012
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Arava : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-11-23
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Arava : EPAR - Scientific Discussion
scientific-discussion · 2005-11-23
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Arava : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-11-23
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。