欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Adenuric
适用类别Human
治疗领域Gout
通用名/非专利名称febuxostat
活性成分febuxostat
产品号EMEA/H/C/000777
患者安全信息No
许可状态Authorised
ATC编码M04AA03
是否额外监管Nei
是否仿制药或hybrid药物Nei
是否生物类似药Nei
是否附条件批准Nei
是否特殊情形Nei
是否加速审评Nei
是否罕用药Nei
上市许可日期2008/04/21
上市许可开发者/申请人/持有人Menarini International Operations Luxembourg S.A. (MIOL)
人用药物治疗学分组Antigout preparations
兽用药物治疗学分组
欧盟委员会决定日期2024/09/12
修订号23
治疗适应症80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuric is indicated in adults.
适用物种
兽用药物ATC编码
首次发布日期2018/05/31
最后更新日期2024/09/13
产品说明书https://www.ema.europa.eu/en/documents/product-information/adenuric-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/adenuric
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