法规知识库 · EMA 集中审评
Lonsurf
trifluridine;tipiracil hydrochloride · EMEA/H/C/003897 · 已授权
获批上市许可
2016-04-25
欧委会决定日
2023-07-26
持有人 / 申请人
Les Laboratoires Servier
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
7
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01BC59
治疗领域:Colorectal Neoplasms
药理分类:Antineoplastic agents
修订号:10 · 最新影响 PI 的程序:II/0026
适应症(原文):Colorectal cancer Lonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents. Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti EGFR agents Gastric cancer Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
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。
2023-07-26 · 欧委会决定
2016-04-25 · 获批上市许可
2016-02-25 · 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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Lonsurf : EPAR - Risk management plan
rmp · 2024-04-05
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Lonsurf : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-04-05
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Lonsurf-H-C-003897-II-0026 : EPAR - Assessment report - Variation
variation-report · 2023-09-11 · EMA/CHMP/221594/2023
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Lonsurf : EPAR - Medicine overview
overview · 2023-09-11 · EMA/301690/2023
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Lonsurf-H-C-003897-II-0012 : EPAR - Assessment report - Variation
variation-report · 2019-10-08 · EMA/479870/2019
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Lonsurf : EPAR - Scientific conclusions on the request for one-year marketing protection presented by the European Medicines Agency
scientific-conclusion · 2019-10-08
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Lonsurf : EPAR - Public assessment report
assessment-report · 2016-05-12 · EMA/CHMP/287846/2016
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。