nitric oxide

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 15/01/2021

Authorisation details

Product details
Agency product number
Active substance
Nitric oxide
International non-proprietary name (INN) or common name
nitric oxide
Therapeutic area (MeSH)
  • Hypertension, Pulmonary
  • Respiratory Insufficiency
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Linde Healthcare AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Rättarvägen 3
169 68 Solna

Product information

20/10/2020 INOmax - EMEA/H/C/000337 - N/0061


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other respiratory system products

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.

Assessment history

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