| 商品名称 | Anagrelide Viatris (previously Anagrelide Mylan) |
|---|---|
| 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 hydrochloride |
| 产品号 | EMEA/H/C/004585 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XX35 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 |
| 上市许可日期 | 2018/02/15 |
| 上市许可开发者/申请人/持有人 | Viatris Limited |
| 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 | 2017/12/14 |
| 欧盟委员会决定日期 | 2025/11/14 |
| 修订号 | 12 |
| 治疗适应症 | Anagrelide Viatris 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 patient An at-risk essential thrombocythaemia patient is defined by one or more of the following features: • >60 years of age or • a platelet count >1,000 x 10⁹/l or • a history of thrombo-haemorrhagic events. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/02/15 |
| 最后更新日期 | 2025/11/14 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/anagrelide-viatris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/anagrelide-viatris |