Affiliations: Medical Affairs Department, Orphan Europe, Paris,
France. E-mail: [email protected]
Abstract: To date, prescription of drugs which are unlicensed and/or
unlabelled in the paediatric population is a concerning reality, particularly
in the neonatal units (90%) and in the paediatric units (49%). Therefore,
there is the need to develop effective and safe pharmacological treatments for
the paediatric population in general.
Keywords: Paediatric population, clinical trial, orphan drug