| 商品名称 | Enrylaze |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| 通用名/非专利名称 | crisantaspase |
| 活性成分 | crisantaspase |
| 产品号 | EMEA/H/C/005917 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | L01XX02 |
| 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 | 2023/09/15 |
| 上市许可持有人/公司名称 | Jazz Pharmaceuticals Ireland Limited |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2023/07/20 |
| 修订号 | |
| 适应症 | Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. |
| 首次发布日期 | 2023/07/17 |
| 修订日期 | 2023/10/05 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/enrylaze-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/enrylaze |