欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称MicardisPlus
适用类别Human
治疗领域Hypertension
通用名/非专利名称
活性成分telmisartan;hydrochlorothiazide
产品号EMEA/H/C/000413
患者安全信息No
许可状态Authorised
ATC编码C09DA07
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2002/04/19
上市许可开发者/申请人/持有人Boehringer Ingelheim International GmbH
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2025/03/29
修订号37
治疗适应症Treatment of essential hypertension. MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. MicardisPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
适用物种
兽用药物ATC编码
首次发布日期2017/04/06
最后更新日期2025/03/31
产品说明书https://www.ema.europa.eu/en/documents/product-information/micardisplus-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/micardisplus
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