KINOX (nitric oxide) - Hypoxic respiratory
Opinions on drugs -
Posted on
Feb 13 2025
Reason for request
First listing
Summary of opinion
Favourable opinion for reimbursement for the treatment of:
- newborn infants of > 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;
- episodes of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, aged 0-17 years in conjunction with heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
No clinical added value of the new forms compared to the forms already available.
Clinical Benefit
Substantial |
The Committee deems that the clinical benefit of KINOX 800 ppm mol/mol (nitric oxide) medicinal gas, compressed is substantial in the MA indications. |
Clinical Added Value
no clinical added value |
This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the forms already listed. |
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