欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ferriprox
适用类别Human
治疗领域beta-Thalassemia;Iron Overload
通用名/非专利名称deferiprone
活性成分Deferiprone
产品号EMEA/H/C/000236
患者安全信息No
许可状态Authorised
ATC编码V03AC02
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1999/08/25
上市许可开发者/申请人/持有人Chiesi Farmaceutici S.p.A.
人用药物治疗学分组All other therapeutic products
兽用药物治疗学分组
欧盟委员会决定日期2025/08/12
修订号33
治疗适应症Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.
适用物种
兽用药物ATC编码
首次发布日期2017/07/04
最后更新日期2025/08/13
产品说明书https://www.ema.europa.eu/en/documents/product-information/ferriprox-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ferriprox
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