| 商品名称 | Capecitabine SUN |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Stomach Neoplasms;Breast Neoplasms;Colonic Neoplasms;Colorectal Neoplasms |
| 通用名/非专利名称 | capecitabine |
| 活性成分 | capecitabine |
| 产品号 | EMEA/H/C/002050 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | L01BC06 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2013/06/21 |
| 上市许可开发者/申请人/持有人 | Sun Pharmaceutical Industries Europe B.V. |
| 人用药物治疗学分组 | capecitabine |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2016/06/21 |
| 修订号 | 3 |
| 治疗适应症 | 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. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2016/06/21 |
| 最后更新日期 | 2016/12/22 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/capecitabine-sun-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/capecitabine-sun |