| 商品名称 | Tecvayli |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Multiple Myeloma |
| 通用名/非专利名称 | teclistamab |
| 活性成分 | teclistamab |
| 产品号 | EMEA/H/C/005865 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01F |
| 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 | No |
| 上市许可日期 | 2022/08/23 |
| 上市许可开发者/申请人/持有人 | Janssen-Cilag International N.V. |
| 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 | 2022/07/21 |
| 欧盟委员会决定日期 | 2025/06/12 |
| 修订号 | 7 |
| 治疗适应症 | TECVAYLI is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/07/18 |
| 最后更新日期 | 2025/10/08 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tecvayli |