欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Eltrombopag Accord
适用类别Human
治疗领域Purpura, Thrombocytopenic, Idiopathic
通用名/非专利名称eltrombopag
活性成分eltrombopag olamine
产品号EMEA/H/C/006459
患者安全信息No
许可状态Authorised
ATC编码B02BX05
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2025/03/28
上市许可开发者/申请人/持有人Accord Healthcare S.L.U.
人用药物治疗学分组Antihemorrhagics
兽用药物治疗学分组
审评意见日期2025/01/30
修订号
治疗适应症Eltrombopag Accord is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Accord is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Accord is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.
适用物种
兽用药物ATC编码
首次发布日期2025/01/31
最后更新日期2025/04/23
产品说明书https://www.ema.europa.eu/en/documents/product-information/eltrombopag-accord-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/eltrombopag-accord
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