法规知识库 · EMA 集中审评
Ayvakyt
avapritinib · EMEA/H/C/005208 · 已授权
获批上市许可
2020-09-24
欧委会决定日
2026-10-16
持有人 / 申请人
Blueprint Medicines (Netherlands) B.V.
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EX18
治疗领域：Gastrointestinal Stromal Tumors
药理分类：Other antineoplastic agents;Protein kinase inhibitors
修订号：12 · 最新影响 PI 的程序：VR/0000348944
适应症（原文）：Unresectable or metastatic gastrointestinal stromal tumour (GIST) AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. Advanced systemic mastocytosis (AdvSM) AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy. Indolent systemic mastocytosis (ISM) AYVAKYT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment (see section 5.1).
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。
2026-10-16 · 欧委会决定
2020-09-24 · 获批上市许可
2020-07-23 · 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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Ayvakyt-VR-0000348944 : EPAR - Assessment report
variation-report · 2026-10-29 · EMADOC-1700519818-3265018
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Ayvakyt : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-29
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Ayvakyt : EPAR - Risk management plan
rmp · 2026-01-09
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Ayvakyt : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-08-06
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Ayvakyt-H-C-005208-II-0023 : EPAR - Assessment report - Variation
variation-report · 2024-02-06 · EMA/548651/2023
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Ayvakyt : Orphan maintenance assessment report (post authorisation) (II-23)
orphan-maintenance-report-post · 2024-02-06 · EMA/OD/0000127063
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Ayvakyt : EPAR - Medicine overview
overview · 2024-02-06 · EMA/68210/2022
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Ayvakyt-H-C-005208-X-0004-G : EPAR - Assessment Report - Variation
variation-report · 2022-05-18 · EMA/CHMP/135619/2022
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Ayvakyt : Orphan maintenance assessment report (post authorisation) (X-04-G)
orphan-maintenance-report-post · 2022-05-18 · EMA/OD/0000071880
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Ayvakyt : EPAR - Public assessment report
assessment-report · 2020-09-30 · EMA/451735/2020
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Ayvakyt : Orphan maintenance assessment report (initial authorisation)
orphan-maintenance-report · 2020-09-30 · EMADOC-1700519818-499131
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。