| 商品名称 | Atriance |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| 通用名/非专利名称 | nelarabine |
| 活性成分 | nelarabine |
| 产品号 | EMEA/H/C/000752 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | L01BB07 |
| 是否额外监管 | yes |
| 是否仿制药 | no |
| 是否生物类似药 | no |
| 是否附条件批准 | no |
| 是否特殊情形 | yes |
| 是否加速审评 | no |
| 是否罕用药 | no |
| 批准上市日期 | 2007/08/22 |
| 上市许可持有人/公司名称 | Sandoz Pharmaceuticals d.d. |
| 人用药物治疗分组 | Antineoplastic agents |
| 决定日期 | 2023/01/16 |
| 修订号 | 26 |
| 适应症 | Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens., , Due to the small patient populations in these disease settings, the information to support these indications is based on limited data., |
| 首次发布日期 | 2018/04/30 |
| 修订日期 | 2023/01/16 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/atriance-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/atriance |