| 商品名称 | Eribulin Baxter |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms;Liposarcoma |
| 通用名/非专利名称 | eribulin |
| 活性成分 | Eribulin mesylate |
| 产品号 | EMEA/H/C/006191 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XX41 |
| 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 | 2024/06/27 |
| 上市许可开发者/申请人/持有人 | Baxter Holding B.V. |
| 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 | 2024/04/25 |
| 欧盟委员会决定日期 | 2024/11/20 |
| 修订号 | 1 |
| 治疗适应症 | Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Eribulin Baxter is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/04/26 |
| 最后更新日期 | 2024/12/02 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/eribulin-baxter-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/eribulin-baxter |