| 商品名称 | Unituxin |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Neuroblastoma |
| 通用名/非专利名称 | dinutuximab |
| 活性成分 | Dinutuximab |
| 产品号 | EMEA/H/C/002800 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | L01FX06 |
| 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 | 2015/08/14 |
| 上市许可开发者/申请人/持有人 | United Therapeutics Europe Ltd |
| 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 | 2015/05/21 |
| 欧盟委员会决定日期 | 2017/03/20 |
| 修订号 | 3 |
| 治疗适应症 | Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/03/20 |
| 最后更新日期 | 2017/04/28 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/unituxin-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/unituxin |