法规知识库 · EMA 集中审评
Farydak
panobinostat lactate anhydrous · EMEA/H/C/003725 · 已授权
获批上市许可
2015-08-28
欧委会决定日
2024-11-28
持有人 / 申请人
pharmaand GmbH
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：L01XH03
治疗领域：Multiple Myeloma
药理分类：Antineoplastic agents
修订号：14 · 最新影响 PI 的程序：II/0030
适应症（原文）：Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
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。
2024-11-28 · 欧委会决定
2015-08-28 · 获批上市许可
2015-06-25 · 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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Farydak : EPAR - Risk management plan
rmp · 2025-10-01
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Farydak : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-10-01
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Farydak-H-C-PSUSA-10409-201908 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-06-16 · EMA/318994/2020
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Farydak-H-C-PSUSA-10409-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-07-05 · EMA/425022/2017
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Farydak : EPAR - Summary for the public
overview · 2015-09-11
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Farydak : EPAR - Public assessment report
assessment-report · 2015-09-11 · EMA/CHMP/496296/2015 Rev. 1
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。