法规知识库 · EMA 集中审评
Xalkori
crizotinib · EMEA/H/C/002489 · 已授权
获批上市许可
2012-10-23
欧委会决定日
2026-01-05
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
19
官方索引 19
EPAR / 审评
16
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01ED01
治疗领域：Carcinoma, Non-Small-Cell Lung
药理分类：Antineoplastic agents
修订号：40 · 最新影响 PI 的程序：VR/0000317352
适应症（原文）：Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC) The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)
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。
2026-01-05 · 欧委会决定
2012-10-23 · 获批上市许可
2012-07-19 · 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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Xalkori : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-09-30
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Xalkori : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-08
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Xalkori : EPAR - Risk management plan
rmp · 2026-01-08
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Xalkori-H-C-002489-P46-026 : EPAR - Assessment report
variation-report · 2025-10-06 · EMA/43612/2025
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Xalkori : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2025-09-29 · EMADOC-1700519818-2457012
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Xalkori-H-C-002489-X-0080-G : EPAR - Assessment report - Variation
variation-report · 2024-09-24 · EMA/351984/2024 Rev1
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Xalkori : EPAR - Medicine overview
overview · 2024-09-24 · EMA/321838/2024
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Xalkori-H-C-002489-II-0072 : EPAR - Assessment report - Variation
variation-report · 2022-12-02 · EMA/846028/2022
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Xalkori-PSUSA-00010042-202108 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-06-27 · EMA/246133/2022
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Xalkori-H-C-002489-P46-025 : EPAR - Assessment Report
variation-report · 2021-08-20 · EMA/CHMP/443216/2021
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Xalkori-H-C-2489-II-0039 : EPAR - Assessment Report - Variation
variation-report · 2016-09-29 · EMA/CHMP/327604/2016
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Xalkori-H-C-PSUSA/00010042/201508 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-05-31 · EMA/375653/2016
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Xalkori-H-C-2489-II-0024 : EPAR - Assessment Report - Variation
variation-report · 2016-01-26 · EMA/CHMP/465053/2015
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Xalkori-H-C-PSUSA-00010042-201502: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-01-13 · EMA/699343/2015
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Xalkori-H-C-2489-PSUV-0012 : EPAR - Scientific conclusions and grounds for recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-06-16 · EMA/342496/2014
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Xalkori : EPAR - Public assessment report
assessment-report · 2012-11-14 · EMA/CHMP/497137/2012
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。