法规知识库 · EMA 集中审评
Zydelig
Idelalisib · EMEA/H/C/003843 · 已授权
获批上市许可
2014-09-18
欧委会决定日
2024-06-20
持有人 / 申请人
Gilead Sciences Ireland UC
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
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01XX47
治疗领域：Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell
药理分类：Antineoplastic agents;Other antineoplastic agents
修订号：21 · 最新影响 PI 的程序：R/0059
适应症（原文）：Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
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。
2024-06-20 · 欧委会决定
2014-09-18 · 获批上市许可
2014-07-25 · 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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Zydelig : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-10-21
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Zydelig : EPAR - Risk-management-plan summary
rmp-summary · 2021-05-20
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Zydelig : EPAR - Medicine overview
overview · 2020-01-10
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Zydelig-H-C-3843-II-0032-G : EPAR - Assessment Report - Variation
variation-report · 2018-08-03 · EMA/202018/2018
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Zydelig-H-C-PSUSA-00010303-201707 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-06-28 · EMA/422302/2018
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Zydelig-H-C-10303-201701 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2017-12-14 · EMA/694281/2017
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Zydelig-H-C-003843-A20-1439-0023 : EPAR - Assessment Report - Article 20
variation-report · 2016-11-21 · EMA/586939/2016
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Zydelig : EPAR - Scientific conclusions
scientific-conclusion · 2016-11-21
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Zydelig-H-C-003843-II-0011 : EPAR - Assessment Report - Variation
variation-report · 2016-11-14 · EMA/CHMP/657576/2016
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Zydelig : EPAR - Public assessment report
assessment-report · 2014-10-14 · EMEA/CHMP/324336/2014
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。