法规知识库 · EMA 集中审评
Venclyxto
venetoclax · EMEA/H/C/004106 · 已授权
获批上市许可
2016-12-04
欧委会决定日
2026-05-27
持有人 / 申请人
AbbVie Deutschland GmbH & Co. KG
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
17
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01XX52
治疗领域：Leukemia, Lymphocytic, Chronic, B-Cell
药理分类：Antineoplastic agents
修订号：23 · 最新影响 PI 的程序：VR/0000322237, VR/0000322240
适应症（原文）：Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib with or without obinutuzumab in combination with obinutuzumab in combination with ibrutinib Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor. Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
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。
2026-05-27 · 欧委会决定
2016-12-04 · 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 ↗
Venclyxto-PAM-0000338556 : EPAR - Assessment report
variation-report · 2026-07-10 · EMADOC-1700519818-3259843
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Venclyxto-VR-0000322237 : EPAR - Assessment report - Variation
variation-report · 2026-07-08 · EMADOC-1700519818-3010802
- 打开官方文件 ↗
Venclyxto-VR-0000322240 : EPAR - Assessment report - Variation
variation-report · 2026-07-08 · EMADOC-1700519818-3013065
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Venclyxto : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-08
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Venclyxto : EPAR - Risk management plan
rmp · 2026-07-08
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Venclyxto : EPAR - Medicine overview
overview · 2026-07-08 · EMA/344462/2021
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Venclyxto : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-22
- 打开官方文件 ↗
Venclyxto-H-C-4106-II-0030 : EPAR - Assessment report - Variation
variation-report · 2025-06-18 · EMA/280804/2021
- 打开官方文件 ↗
Venclyxto-H-C-004106-P46-018 : EPAR - Assessment report
variation-report · 2024-04-10 · EMA/25886/2024
- 打开官方文件 ↗
Venclyxto-H-C-004106-P46-01: EPAR - Assessment report
variation-report · 2021-09-09 · EMA/425184/2021
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Venclyxto-H-C-PSUSA-00010556-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-04-24 · EMA/210143/2020
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Venclyxto-H-C-4106-II-0023-G : EPAR - Assessment report - Variation
variation-report · 2020-04-24 · EMA/166265/2020
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Venclyxto-H-C-4106-II-0011 : EPAR - Assessment report - Variation
variation-report · 2018-12-05 · EMA/CHMP/717206/2018
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Venclyxto : Orphan designation withdrawal assessment report (post-authorisation)
orphan-maintenance-report-post · 2018-11-22 · EMA/COMP/115810/2018
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Venclyxto-H-C-4106-II-0008 : EPAR - Assessment report - Variation
variation-report · 2018-11-06 · EMA/CHMP/717199/2018
- 打开官方文件 ↗
Venclyxto : EPAR - Public assessment report
assessment-report · 2016-12-21 · EMA/725631/2016
- 打开官方文件 ↗
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation
scientific-conclusion · 2016-12-21
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。