US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| INOMAX | 800PPM; 4880PPM | gas · inhalation | MALLINCKRODT IRELAND | Prescription | 23 Dec 1999 |
| NOXIVENT | 800PPM | gas · inhalation | VERO BIOTECH INC | Prescription | 2 Oct 2018 |
| GENOSYL | 800PPM | gas · inhalation | VERO BIOTECH INC | Prescription | 20 Dec 2019 |
| ULSPIRA | 800PPM | gas · inhalation | AIRGAS THERAP | Prescription | 27 Jul 2023 |
| INOMAX | 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | gas · inhalation | MALLINCKRODT IRELAND | Discontinued | 23 Dec 1999 |
| NOXIVENT | 100PPM | gas · inhalation | VERO BIOTECH INC | Discontinued | 2 Oct 2018 |
EMA European Union — centrally authorised medicines
INOmax Linde Healthcare AB · Authorised · authorised 1 Aug 2001 · ATC R07AX
Therapeutic indication (EMA)
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.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| INOMAX | 02270846 | 800 PPM / CYLR | GAS · INHALATION | INO THERAPEUTICS |
| KINOX | 02451328 | 800 PPM / CYLR | GAS · INHALATION | AIRGAS THERAPEUTICS LLC |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.