法规知识库 · EMA 集中审评
Dasatinib Accord Healthcare
Dasatinib monohydrate · EMEA/H/C/006251 · 已授权
获批上市许可
2024-07-26
欧委会决定日
2026-02-04
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
4
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:L01EA02
治疗领域:Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive
药理分类:Antineoplastic agents
修订号:3 · 最新影响 PI 的程序:VR/0000324500
适应症(原文):Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with 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。
2026-02-04 · 欧委会决定
2024-07-26 · 获批上市许可
2024-05-30 · 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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Dasatinib Accord Healthcare : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-02-05
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Dasatinib Accord Healthcare : EPAR - Risk management plan
rmp · 2025-11-13
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Dasatinib Accord Healthcare : EPAR - Medicine overview
overview · 2024-08-01 · EMA/317632/2024
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Dasatinib Accord Healthcare : EPAR - Public assessment report
assessment-report · 2024-08-01 · EMA/313181/2024
产品信息
- 打开官方文件 ↗
Dasatinib Accord Healthcare : EPAR - Product information - tracked changes
product-information-tracked-changes · 2026-02-05
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Dasatinib Accord Healthcare : EPAR - Product information
product-information · 2026-02-05
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Dasatinib Accord Healthcare : EPAR - All authorised presentations
all-authorised-presentations · 2025-08-21
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。