欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
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
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
上市许可日期2004/11/15
上市许可开发者/申请人/持有人Takeda Pharmaceuticals International AG Ireland
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
欧盟委员会决定日期2023/02/16
修订号40
治疗适应症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 patient An 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.
适用物种
兽用药物ATC编码
首次发布日期2018/07/11
最后更新日期2023/02/20
产品说明书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
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase