法规知识库 · EMA 集中审评
Bosulif
bosutinib (as monohydrate) · EMEA/H/C/002373 · 已授权
获批上市许可
2013-03-27
欧委会决定日
2026-01-11
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EA04
治疗领域：Leukemia, Myeloid
药理分类：Antineoplastic agents;Protein kinase inhibitors
修订号：29 · 最新影响 PI 的程序：VR/0000319527
适应症（原文）：Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.• Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
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。
2026-01-11 · 欧委会决定
2013-03-27 · 获批上市许可
2013-01-17 · 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
- 打开官方文件 ↗
Bosulif : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-12
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Bosulif-H-C-002373-X-0058-G : EPAR - Assessment report - Variation
variation-report · 2025-08-26 · EMA/195854/2025
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Bosulif : EPAR - Risk management plan
rmp · 2025-08-26
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Bosulif : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-08-26
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Bosulif : EPAR - Medicine overview
overview · 2025-08-26 · EMA/126710/2025
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Bosulif-H-C-002373-II-0050-G:EPAR - Assessment report - Variation
variation-report · 2022-05-03 · EMA/126509/2022
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Bosulif-H-C-PSUSA-00010073-202003:EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-01-29 · EMA/58304/2021
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Bosulif-H-C-2373-II-0025-G : EPAR - Assessment Report - Variation
variation-report · 2018-05-07 · EMA/CHMP/187737/2018
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Bosulif : Orphan designation withdrawal assessment report (post-authorisation)
orphan-maintenance-report-post · 2018-05-07 · EMA/214220/2018
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Bosulif-H-C-PSUSA-00010073-201603:EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-12-09
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Bosulif-H-C-PSUSA-00010073-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-01-08 · EMA/CHMP/820763/2015
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Bosulif : EPAR - Public assessment report
assessment-report · 2013-04-09 · EMA/70979/2013
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。