| 商品名称 | Ordspono |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Lymphoma, Follicular |
| 通用名/非专利名称 | odronextamab |
| 活性成分 | odronextamab |
| 产品号 | EMEA/H/C/006215 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | Not yet assigned |
| 是否额外监管 | Yes |
| 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 | Yes |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | Yes |
| 上市许可日期 | 2024/08/22 |
| 上市许可开发者/申请人/持有人 | Regeneron Ireland Designated Activity Company (DAC) |
| 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 | 2024/06/27 |
| 欧盟委员会决定日期 | 2025/07/23 |
| 修订号 | 1 |
| 治疗适应症 | Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy. Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/06/28 |
| 最后更新日期 | 2025/09/19 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ordspono-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono |