法规知识库 · EMA 集中审评
Sprycel
dasatinib · EMEA/H/C/000709 · 已授权
获批上市许可
2006-11-20
欧委会决定日
2026-09-03
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
23
官方索引 23
EPAR / 审评
20
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：48 · 最新影响 PI 的程序：VR/0000356665
适应症（原文）：Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. Sprycel 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 mesilate; Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Sprycel 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.
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。
2026-09-03 · 欧委会决定
2006-11-20 · 获批上市许可
2006-09-21 · 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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Sprycel : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-02
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Sprycel : EPAR - Risk management plan
rmp · 2026-10-02
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Sprycel-PAM-0000291073 : EPAR - Assessment report
variation-report · 2026-03-06 · EMADOC-1700519818-2348379
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Sprycel : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-15
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Sprycel-PSUSA-00000935-202106 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-04-21 · EMA/176825/2022
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Sprycel-H-C-709-P46-048 : EPAR - Assessment report
variation-report · 2022-02-25 · EMA/119741/2022
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Sprycel-H-C-709-P46-047 : EPAR - Assessment report
variation-report · 2021-02-16 · EMA/500437/2020
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Sprycel-PSUSA-00000935-201806 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-04-16 · EMA/227269/2019
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Sprycel-H-C-709-II-0059 : EPAR - Assessment report - Variation
variation-report · 2019-03-29 · EMA/CHMP/3851/2019
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Sprycel : EPAR - Medicine overview
overview · 2019-03-29
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Sprycel-H-C-000709-X-0056-G : EPAR - Assessment Report - Variation
variation-report · 2018-07-09 · EMA/CHMP/302652/2018
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Sprycel-H-C-709-P46-0041 : EPAR - Assessment report
variation-report · 2015-12-17 · EMA/725514/2015
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Sprycel-H-C-709-PSUV-0041 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-08-06 · EMA/CHMP/109489/2015
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Sprycel-H-C-709-A46-0035 : EPAR - Assessment Report
variation-report · 2012-05-23 · EMA/273206/2012
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Sprycel-H-709-II-0023 : EPAR - Assessment Report - Variation
variation-report · 2010-12-22 · EMA/761358/2010
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Sprycel-H-C-709-II-0010 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2009-05-13
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Sprycel-H-C-709-II-0008 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-09-01
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Sprycel-H-C-709-II-0002 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-11-27
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Sprycel : EPAR - Scientific Discussion
scientific-discussion · 2006-11-30
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Sprycel : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-11-30
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。