欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Revatio
适用类别Human
治疗领域Hypertension, Pulmonary
通用名/非专利名称sildenafil
活性成分sildenafil
产品号EMEA/H/C/000638
患者安全信息no
授权状态Authorised
ATC编码G04BE03
是否额外监管no
是否仿制药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
批准上市日期2005/10/28
上市许可持有人/公司名称Upjohn EESV
人用药物治疗分组Urologicals
审评意见发布日期2005/07/27
决定日期2023/09/26
修订号50
适应症Treatment of adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.Paediatric populationTreatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.Revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
首次发布日期2018/07/30
修订日期2023/11/20
产品信息https://www.ema.europa.eu/en/documents/product-information/revatio-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/revatio
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