NeoVanc – Treatment of late onset bacterial sepsis caused by Vancomycin susceptible bacteria in neonates and infants aged under three months
The NeoVanc project’s objective is the marketing of a new formulation of vancomycin for the treatment of neonatal sepsis in patients up to 3 months of age.
Throughout the project clinical and preclinical studies will be conducted in accordance with the Paediatric Investigation Plan (PIP) approved by the Paediatric Committee at the European Medicinal Agency. Such studies are aimed at defining the pharmacokinetics of this antibiotic as well as at identifying the optimal dosages for its use in the paediatric population.
The achieved results will support the application for a Paediatric Use Marketing Authorisation (PUMA) of the formulation intended for neonates and infants under 3 months of life.