Reason for request
Inclusion on the list of medicines approved for hospital use for the extension of indication: “treatment of premature neonates at high risk from respiratory distress syndrome (RDS) due to pulmonary surfactant deficiency (hyaline membrane disease)”.
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Clinical Benefit
Substantial |
The Actual Benefit of CUROSURF in the treatment of premature neonates with high risk of RDS is substantial. |
Clinical Added Value
important |
The Transparency Committee considers that CUROSURF provides a significant improvement in actual benefit (IAB II) in the management of neonates of less than 28 weeks of amenorrhoea (26 weeks gestational age), at high risk from respiratory distress syndrome (RDS) due to pulmonary surfactant deficiency (hyaline membrane disease). |
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Évaluation des médicaments