| 商品名称 | Padcev |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Carcinoma, Transitional Cell; Urologic Neoplasms |
| 通用名/非专利名称 | enfortumab vedotin |
| 活性成分 | Enfortumab vedotin |
| 产品号 | EMEA/H/C/005392 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | L01FX13 |
| 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 | 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 | 2022/04/13 |
| 上市许可持有人/公司名称 | Astellas Pharma Europe B.V. |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2022/02/24 |
| 决定日期 | 2023/04/26 |
| 修订号 | 1 |
| 适应症 | Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor. |
| 首次发布日期 | 2022/05/05 |
| 修订日期 | 2023/05/08 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/padcev |