欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Adempas
适用类别Human
治疗领域Hypertension, Pulmonary
通用名/非专利名称riociguat
活性成分riociguat
产品号EMEA/H/C/002737
患者安全信息No
许可状态Authorised
ATC编码C02KX05
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2014/03/27
上市许可开发者/申请人/持有人Bayer AG
人用药物治疗学分组Antihypertensives for pulmonary arterial hypertension
兽用药物治疗学分组
审评意见日期2014/01/23
欧盟委员会决定日期2025/08/06
修订号17
治疗适应症Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. Pulmonary arterial hypertension (PAH) AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists. 
适用物种
兽用药物ATC编码
首次发布日期2018/03/07
最后更新日期2025/12/03
产品说明书https://www.ema.europa.eu/en/documents/product-information/adempas-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/adempas
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