INOmax (nitric oxide)
- Region
- 🇪🇺 EU
- Active substance
- nitric oxide
- Company
- Linde Healthcare AB
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary; Respiratory Insufficiency
- EU approval
- Wed 01 Aug 2001
- Application
- EMEA/H/C/000337
- ATC
- R07AX
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.