INOmax

RSS

nitric oxide

Authorised
This medicine is authorised for use in the European Union.

Overview

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 24/04/2018

Authorisation details

Product details
Name
INOmax
Agency product number
EMEA/H/C/000337
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
R07AX
Publication details
Marketing-authorisation holder
Linde Healthcare AB
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
01/08/2001
Contact address
S-18181 Lidingö
Sweden

Product information

22/03/2018 INOmax - EMEA/H/C/000337 - II/0051

Contents

  • 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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