法规知识库 · EMA 集中审评
Cabometyx
cabozantinib (s)-malate · EMEA/H/C/004163 · 已授权
获批上市许可
2016-09-09
欧委会决定日
2026-01-15
持有人 / 申请人
Ipsen Pharma
终止日期字段
无
从产品到官方文件
文件记录
17
官方索引 17
EPAR / 审评
14
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EX07
治疗领域：Carcinoma, Renal Cell;Carcinomas, Hepatocellular
药理分类：Antineoplastic agents
修订号：21 · 最新影响 PI 的程序：VR/0000271719
适应症（原文）：Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
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。
2026-01-15 · 欧委会决定
2016-09-09 · 获批上市许可
2016-07-21 · 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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Cabometyx : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-10-15 · EMADOC-1700519818-3494988
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Cabometyx : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-15
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Cabometyx : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-07
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Cabometyx-H-C-004163-II-0040 : EPAR - Assessment report - Variation
variation-report · 2025-09-17 · EMA/CHMP/138089/2025
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Cabometyx : EPAR - Risk-management-plan
rmp · 2025-09-17
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Cabometyx : EPAR - Medicine overview
overview · 2025-09-17 · EMA/189718/2022
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Cabometyx-H-C-004163-P46 : EPAR - Assessment report
variation-report · 2023-04-05 · EMA/CHMP/68009/2023
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Cabometyx-H-C-PSUSA-00010180-202111: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2022-10-25 · EMA/846935/2022
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Cabometyx-H-C-004163-II-0023 : EPAR - Assessment report - Variation
variation-report · 2022-06-09 · EMA/214682/2022
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Cabometyx-H-C-004163-II-0017 : EPAR - Assessment report - Variation
variation-report · 2021-04-21 · EMA/145012/2021
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Cabometyx-H-C-004163-II-0005 : EPAR - Assessment report - Variation
variation-report · 2019-01-24 · EMA/704052/2018
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Cabometyx-H-C-PSUSA-00010180-201711: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-09-13 · EMA/517947/2018
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Cabometyx-H-C-004163-II-0003 : EPAR - Assessment report - Variation
variation-report · 2018-06-07 · EMA/235286/2018
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Cabometyx : EPAR - Public assessment report
assessment-report · 2016-10-12 · EMA/664123/2016
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。