法规知识库 · EMA 集中审评
Besponsa
Inotuzumab ozogamicin · EMEA/H/C/004119 · 已授权
获批上市许可
2017-06-28
欧委会决定日
2026-05-06
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
12
官方索引 12
EPAR / 审评
9
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FB01
治疗领域：Precursor Cell Lymphoblastic Leukemia-Lymphoma
药理分类：Antineoplastic agents
修订号：12 · 最新影响 PI 的程序：VR/0000257310
适应症（原文）：Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult pPatients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting 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。
2026-05-06 · 欧委会决定
2017-06-28 · 获批上市许可
2017-04-20 · 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 ↗
Besponsa-VR-0000257310 : EPAR - Assessment report - Variation
variation-report · 2026-05-18 · EMADOC-1700519818-3075832
- 打开官方文件 ↗
Besponsa-PAM-0000319860 : EPAR - Assessment report
variation-report · 2026-05-18 · EMADOC-1700519818-3071647
- 打开官方文件 ↗
Besponsa : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-18
- 打开官方文件 ↗
Besponsa : EPAR - Risk management plan
rmp · 2026-05-18
- 打开官方文件 ↗
Besponsa : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-05-18
- 打开官方文件 ↗
Besponsa : EPAR - Medicine overview
overview · 2026-05-18 · EMADOC-1829012207-48119
- 打开官方文件 ↗
Besponsa-H-C-004119-II-0026 : EPAR - Assessment report - Variation
variation-report · 2024-02-15 · EMA/3833/2024
- 打开官方文件 ↗
Besponsa-H-C-004119-P46-004 : EPAR - Assessment report
variation-report · 2024-02-15 · EMA/3836/2024
- 打开官方文件 ↗
Besponsa : EPAR - Public assessment report
assessment-report · 2017-12-12 · EMA/289046/2017
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。