| 商品名称 | Zynlonta |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell |
| 通用名/非专利名称 | loncastuximab tesirine |
| 活性成分 | loncastuximab tesirine |
| 产品号 | EMEA/H/C/005685 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | L01FX22 |
| 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 | yes |
| 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 | 2022/12/20 |
| 上市许可持有人/公司名称 | Swedish Orphan Biovitrum AB |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2022/09/15 |
| 决定日期 | 2023/04/28 |
| 修订号 | 2 |
| 适应症 | Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy. |
| 首次发布日期 | 2022/09/14 |
| 修订日期 | 2023/05/02 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/zynlonta-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/zynlonta |