This is a summary of the European public assessment report (EPAR) for INOmax. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for INOmax.
Therapeutic Indication
### Therapeutic indication 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.
Therapeutic Area (MeSH)
ATC Code
R07AX
ATC Item
其它呼吸系统药物
Pharmacotherapeutic Group
Other respiratory system products
Active Substance (Summary)
INN / Common Names
EMA Name
INOmax
Medicine Name
INOmax
Aliases
N/ANo risk management plan link.