| 商品名称 | Lumoxiti |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Leukemia, Hairy Cell |
| 通用名/非专利名称 | moxetumomab pasudotox |
| 活性成分 | Moxetumomab pasudotox |
| 产品号 | EMEA/H/C/005322 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | L01X |
| 是否额外监管 | no |
| 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 | no |
| 是否加速审评 | no |
| 是否罕用药 | no |
| 批准上市日期 | 2021/02/08 |
| 上市许可持有人/公司名称 | AstraZeneca AB |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2020/12/10 |
| 决定日期 | 2021/07/23 |
| 修订号 | |
| 适应症 | Lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (PNA). |
| 首次发布日期 | 2021/03/09 |
| 修订日期 | 2021/08/11 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/lumoxiti-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/lumoxiti |