欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Riprazo HCT
适用类别Human
治疗领域Hypertension
通用名/非专利名称aliskiren;hydrochlorothiazide
活性成分aliskiren;hydrochlorothiazide
产品号EMEA/H/C/002420
患者安全信息No
许可状态Withdrawn
ATC编码C09XA52
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2011/04/13
上市许可开发者/申请人/持有人Novartis Europharm Ltd.
人用药物治疗学分组Agents acting on the renin-angiotensin system
兽用药物治疗学分组
欧盟委员会决定日期2012/08/30
修订号
治疗适应症Treatment of essential hypertension in adults. Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rirpozo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
适用物种
兽用药物ATC编码
首次发布日期2012/08/30
最后更新日期2012/09/20
产品说明书https://www.ema.europa.eu/en/documents/product-information/riprazo-hct-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/riprazo-hct
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