| 商品名称 | Ebvallo |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Lymphoproliferative Disorders |
| 通用名/非专利名称 | tabelecleucel |
| 活性成分 | Tabelecleucel |
| 产品号 | EMEA/H/C/004577 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | |
| 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 | yes |
| 是否加速审评 | no |
| 是否罕用药 | yes |
| 批准上市日期 | 2022/12/16 |
| 上市许可持有人/公司名称 | Pierre Fabre Medicament |
| 审评意见发布日期 | 2022/10/13 |
| 决定日期 | 2023/03/09 |
| 修订号 | 2 |
| 适应症 | Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. |
| 首次发布日期 | 2022/10/12 |
| 修订日期 | 2023/03/10 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/ebvallo-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ebvallo |