欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Lonsurf
适用类别Human
治疗领域Colorectal Neoplasms
通用名/非专利名称trifluridine;tipiracil
活性成分trifluridine;tipiracil hydrochloride
产品号EMEA/H/C/003897
患者安全信息No
许可状态Authorised
ATC编码L01BC59
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2016/04/25
上市许可开发者/申请人/持有人Les Laboratoires Servier
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2016/02/25
欧盟委员会决定日期2023/07/26
修订号10
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2017/08/14
最后更新日期2024/04/05
产品说明书https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/lonsurf
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