欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称INOmax
适用类别Human
治疗领域Hypertension, Pulmonary;Respiratory Insufficiency
通用名/非专利名称nitric oxide
活性成分nitric oxide
产品号EMEA/H/C/000337
患者安全信息No
许可状态Authorised
ATC编码R07AX
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2001/08/01
上市许可开发者/申请人/持有人Linde Healthcare AB
人用药物治疗学分组Other respiratory system products
兽用药物治疗学分组
欧盟委员会决定日期2025/05/15
修订号25
治疗适应症INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ?34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
适用物种
兽用药物ATC编码
首次发布日期2018/03/22
最后更新日期2025/05/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/inomax-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/inomax
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase