法规知识库 · EMA 集中审评
Leflunomide Zentiva (previously Leflunomide Winthrop)
leflunomide · EMEA/H/C/001129 · 已授权
获批上市许可
2010-01-08
欧委会决定日
2026-09-22
持有人 / 申请人
Zentiva k.s.
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
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：24 · 最新影响 PI 的程序：VR/0000368533
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。
2026-09-22 · 欧委会决定
2010-01-08 · 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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Leflunomide Zentiva : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-22
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Leflunomide Zentiva (previously Leflunomide Winthrop) : EPAR - Risk management plan
rmp · 2026-09-22
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Leflunomide Zentiva (previously Leflunomide Winthrop) : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-01-09
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Leflunomide-H-C-PSUSA-00001837-202309 : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2024-08-14 · EMA/352982/2024
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Leflunomide Zentiva (previously Leflunomide Winthrop) : EPAR - Medicine overview
overview · 2019-06-13
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Leflunomide Winthrop : EPAR - Public assessment report
assessment-report · 2010-01-22
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。