欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Opsumit
适用类别Human
治疗领域Hypertension, Pulmonary
通用名/非专利名称macitentan
活性成分macitentan
产品号EMEA/H/C/002697
患者安全信息No
许可状态Authorised
ATC编码C02KX04
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2013/12/20
上市许可开发者/申请人/持有人Janssen-Cilag International N.V.  
人用药物治疗学分组Antihypertensives
兽用药物治疗学分组
欧盟委员会决定日期2025/12/16
修订号26
治疗适应症Adults Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Paediatric populationOpsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHO Functional Class (FC) II to III. Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 2 years to less than 18 years with WHO Functional Class (FC) II to III.
适用物种
兽用药物ATC编码
首次发布日期2018/08/23
最后更新日期2025/12/16
产品说明书https://www.ema.europa.eu/en/documents/product-information/opsumit-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/opsumit
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