法规知识库 · EMA 集中审评
Calquence
acalabrutinib · EMEA/H/C/005299 · 已授权
获批上市许可
2020-11-05
欧委会决定日
2026-08-25
持有人 / 申请人
AstraZeneca AB
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：L01EL02
治疗领域：Leukemia, Lymphocytic, Chronic, B-Cell
药理分类：Antineoplastic agents
修订号：13 · 最新影响 PI 的程序：PSUR/0000327904
适应症（原文）：Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.
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。
2026-08-25 · 欧委会决定
2020-11-05 · CHMP 意见通过
2020-11-05 · 获批上市许可
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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Calquence-PSUSA-00010887-202510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-07 · EMADOC-1700519818-3490819
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Calquence : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-07
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Calquence : EPAR - Risk management plan
rmp · 2026-07-06
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Calquence-H-C-005299-II-0025 : EPAR - Assessment report
variation-report · 2025-11-28 · EMA/176133/2025
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Calquence : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-09-19
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Calquence : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-19
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Calquence-H-C-005299-II-0028 : EPAR - Assessment report - Variation
variation-report · 2025-07-15 · EMA/CHMP/124570/2025
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Calquence : EPAR - Medicine overview
overview · 2025-07-15 · EMA/161301/2025
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Calquence-H-C-005299-II-0026 : EPAR - Assessment report extension of indication
variation-report · 2025-05-27 · EMA/CHMP/50170/2025
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Calquence-H-C-005299-X-0009-G : EPAR - Assessment report
variation-report · 2023-03-06 · EMA/38803/2023
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Calquence : EPAR - Public assessment report
assessment-report · 2020-11-11 · EMA/CHMP/458179/2020
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Calquence : Orphan designation withdrawal assessment report (initial authorisation)
orphan-maintenance-report · 2020-11-11 · EMA/OD/0000021547
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。