🇪🇺 Nitric oxide by inhalation INOMAX in European Union

EMA authorised Nitric oxide by inhalation INOMAX on 1 August 2001

Marketing authorisation

Application: EMEA/H/C/000337
Marketing authorisation holder: Linde Healthcare AB
Local brand name: INOmax
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
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Nitric oxide by inhalation INOMAX approved in European Union?

Yes. EMA authorised it on 1 August 2001.

Who is the marketing authorisation holder for Nitric oxide by inhalation INOMAX in European Union?

Linde Healthcare AB holds the EU marketing authorisation.