法规知识库 · EMA 集中审评
Capecitabine SUN
capecitabine · EMEA/H/C/002050 · 已撤市
获批上市许可
2013-06-21
欧委会决定日
2016-06-21
持有人 / 申请人
Sun Pharmaceutical Industries Europe B.V.
终止日期字段
2021-06-21
从产品到官方文件
文件记录
5
官方索引 5
EPAR / 审评
3
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01BC06
治疗领域：Stomach Neoplasms;Breast Neoplasms;Colonic Neoplasms;Colorectal Neoplasms
药理分类：capecitabine
修订号：3 · 最新影响 PI 的程序：IB/0007
适应症（原文）：Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine is indicated for the treatment of metastatic colorectal cancer. Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine 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. Capecitabine 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。
2021-06-21 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2016-06-21 · 欧委会决定
2013-06-21 · 获批上市许可
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
- 打开官方文件 ↗
Capecitabine SUN : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2016-12-22
- 打开官方文件 ↗
Capecitabine SUN : EPAR - Summary for the public
overview · 2016-12-22 · EMA/411926/2013
- 打开官方文件 ↗
Capecitabine SUN : EPAR - Public assessment report
assessment-report · 2016-12-22 · EMA/370014/2013
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。