法规知识库 · EMA 集中审评
Repso
leflunomide · EMEA/H/C/001222 · 已撤市
获批上市许可
2011-03-14
欧委会决定日
2016-03-30
持有人 / 申请人
Teva B.V.
终止日期字段
2017-07-19
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AA13
治疗领域：Arthritis, Rheumatoid;Arthritis, Psoriatic
药理分类：Immunosuppressants
修订号：11 · 最新影响 PI 的程序：IA/0020
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。
2017-07-19 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2016-03-30 · 欧委会决定
2011-03-14 · 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
- 打开官方文件 ↗
Repso : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2016-04-21
- 打开官方文件 ↗
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2011-03-28
- 打开官方文件 ↗
Repso : EPAR - Public assessment report
assessment-report · 2011-03-28 · EMA/79461/2011
- 打开官方文件 ↗
Repso : EPAR - Summary for the public
overview · 2011-03-28 · EMA/149379/2011
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。