欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Imprida HCT
适用类别Human
治疗领域Hypertension
通用名/非专利名称amlodipine;valsartan;hydrochlorothiazide
活性成分amlodipine;valsartan;hydrochlorothiazide
产品号EMEA/H/C/001161
患者安全信息No
许可状态Lapsed
ATC编码C09DX01
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2009/10/15
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Angiotensin II antagonists, plain;Angiotensin II antagonists, combinations
兽用药物治疗学分组
欧盟委员会决定日期2012/10/20
修订号3
治疗适应症Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
适用物种
兽用药物ATC编码
首次发布日期2012/10/20
最后更新日期2012/10/22
产品说明书https://www.ema.europa.eu/en/documents/product-information/imprida-hct-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/imprida-hct
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