| 商品名称 | Arzerra |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Leukemia, Lymphocytic, Chronic, B-Cell |
| 通用名/非专利名称 | ofatumumab |
| 活性成分 | ofatumumab |
| 产品号 | EMEA/H/C/001131 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | L01XC10 |
| 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 | 2010/04/19 |
| 上市许可开发者/申请人/持有人 | Novartis Europharm Ltd |
| 人用药物治疗学分组 | Monoclonal antibodies |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2017/10/02 |
| 修订号 | 16 |
| 治疗适应症 | Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Relapsed CLL: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL. Refractory CLL: Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/10/02 |
| 最后更新日期 | 2019/05/10 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/arzerra-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra |