法规知识库 · EMA 集中审评
Imbruvica
ibrutinib · EMEA/H/C/003791 · 已授权
获批上市许可
2014-10-21
欧委会决定日
2026-09-14
持有人 / 申请人
Janssen-Cilag International NV
终止日期字段
无
从产品到官方文件
文件记录
31
官方索引 31
EPAR / 审评
28
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EL01
治疗领域：Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, Chronic, B-Cell
药理分类：Antineoplastic agents;Protein kinase inhibitors
修订号：38 · 最新影响 PI 的程序：PSUR/0000336107
适应症（原文）：Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
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。
2026-09-14 · 欧委会决定
2014-10-21 · 获批上市许可
2014-07-25 · 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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Imbruvica : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-07
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Imbruvica : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-27
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Imbruvica-H-C-003791-II-0092 : EPAR - Assessment report - Variation
variation-report · 2025-09-10 · EMA/CHMP/200822/2025
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Imbruvica : EPAR - Medicine overview
overview · 2025-09-10 · EMA/635597/2022
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Imbruvica-H-C-PSUSA-00010301-202311 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-09-20 · EMA/437838/2024
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Imbruvica : EPAR - Risk-management-plan summary
rmp-summary · 2024-01-18
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Imbruvica -H-C-PSUSA-10301-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2023-09-22 · EMA/334777/2023
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Imbruvica : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2022-09-22 · EMA/630579/2022
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Imbruvica-H-C-003791-II-0070 : EPAR - Assessment Report - Variation
variation-report · 2022-08-18 · EMA/667445/2022
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Imbruvica-H-C-003791-P46-03 : EPAR - Assessment Report
variation-report · 2022-08-18 · EMA/190958/2022
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Imbruvica-H-C-003791-P46-036 : EPAR - Assessment report
variation-report · 2022-08-18 · EMA/190956/2022
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Imbruvica-H-C-003791-P46-037 : EPAR - Assessment Report
variation-report · 2022-08-18 · EMA/CHMP/241590/2022
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Imbruvica-H-C-PSUSA-00010301-202011 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-08-27 · EMA/403012/2021
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Imbruvica-H-C-3791-II-0059 : EPAR - Assessment Report - Variation
variation-report · 2020-09-14 · EMA/CHMP/452512/2020
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Imbruvica-H-C-PSUSA-00010301-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-08-25 · EMA/445661/2020
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Imbruvica-H-C-3791-II-0046: EPAR - Assessment Report - Variation
variation-report · 2019-12-04 · EMA/CHMP/644926/2019
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Imbruvica-H-C-3791-II-0047: EPAR - Assessment Report - Variation
variation-report · 2019-12-04 · EMA/CHMP/644912/2019
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Imbruvica-H-C-PSUSA-00010301-201705 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-11-12 · EMA/CHMP/608212/2019
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Imbruvica-H-C-PSUSA-00010301-201811 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-11-12 · EMA/CHMP/351105/2019
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Imbruvica-H-C-PSUSA-00010301-201705 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-11-12 · EMA/CHMP/608212/2019
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Imbruvica-H-C-PSUSA-00010301-201811 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-11-12 · EMA/CHMP/351105/2019
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Imbruvica : Orphan designation assessment report (post-authorisation)
orphan-maintenance-report-post · 2019-09-25 · EMADOC-2005359794-147797
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Imbruvica-H-C-PSUSA-00010301-201611 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-09-29 · EMA/CHMP/644858/2017
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Imbruvica- H-C-PSUSA-00010301-201605 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-03-31 · EMA/215182/2017
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Imbruvica-H-C-3791-II-0017 : EPAR - Assessment Report - Variation
variation-report · 2016-10-06
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Imbruvica-H-C-3791-II-00016: EPAR - Assessment Report - Variation
variation-report · 2016-06-09 · EMA/373867/2016
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Imbruvica-H-C-3791-II-0001 : EPAR - Assessment Report - Variation
variation-report · 2015-08-13 · EMA/CHMP/473724/2015
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Imbruvica : EPAR - Public assessment report
assessment-report · 2014-11-25 · EMA/CHMP/645137/2014
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。