| 商品名称 | Xagrid |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Thrombocythemia, Essential |
| 通用名/非专利名称 | anagrelide |
| 活性成分 | Anagrelide |
| 产品号 | EMEA/H/C/000480 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | L01XX35 |
| 是否额外监管 | no |
| 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 | 2004/11/15 |
| 上市许可持有人/公司名称 | Takeda Pharmaceuticals International AG Ireland Branch |
| 人用药物治疗分组 | Antineoplastic agents |
| 决定日期 | 2023/02/16 |
| 修订号 | 40 |
| 适应症 | Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.An at-risk patientAn at-risk ET is defined by one or more of the following features:>60 years of age or;a platelet count >1000 x 109/l or;a history of thrombohaemorrhagic events. |
| 首次发布日期 | 2018/07/11 |
| 修订日期 | 2023/02/20 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/xagrid-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/xagrid |