法规知识库 · EMA 集中审评
Ecansya (previously Capecitabine Krka)
capecitabine · EMEA/H/C/002605 · 已授权
获批上市许可
2012-04-20
欧委会决定日
2025-04-04
持有人 / 申请人
KRKA tovarna zdravil d.d. Novo mesto
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：L01BC06
治疗领域：Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms
药理分类：Antineoplastic agents
修订号：16 · 最新影响 PI 的程序：PSUSA/00000531/202404
适应症（原文）：Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Ecansya is indicated for the treatment of metastatic colorectal cancer. Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Ecansya in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Ecansya is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
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。
2025-04-04 · 欧委会决定
2012-04-20 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Ecansya-H-C-PSUSA-00000531-202404 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-05-05 · EMA/151502/2025
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Ecansya : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-05
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Ecansya-H-C-2605-A31-0023 : EPAR - Assessment Report - Article 31
variation-report · 2020-07-31 · EMA/274404/2020
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Ecansya : EPAR - Scientific conclusions
scientific-conclusion · 2020-07-31
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Ecansya : EPAR - Medicine overview
overview · 2020-07-31 · EMA/374044/2020
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Ecansya-H-C-PSUSA-00000531-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-08-12 · EMA/CHMP/455409/2019
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Capecitabine Krka : EPAR - Public assessment report
assessment-report · 2012-05-07 · EMA/199988/2012
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。