欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Volibris
适用类别Human
治疗领域Hypertension, Pulmonary
通用名/非专利名称ambrisentan
活性成分ambrisentan
产品号EMEA/H/C/000839
患者安全信息No
许可状态Authorised
ATC编码C02KX02
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2008/04/20
上市许可开发者/申请人/持有人GlaxoSmithKline Trading Services Limited
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2024/03/14
修订号26
治疗适应症Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).  Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).
适用物种
兽用药物ATC编码
首次发布日期2017/04/26
最后更新日期2025/07/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/volibris-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/volibris
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