Role of CVBF
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.
Seventh Framework Programme, European Commission
7.8 million euro
5.9 milioni di euro
(1) Fondazione PENTA, Italy; (2) St George’s Hospital Medical School, UK; (3) Institut National de la Santé et de la RechercheMédicale, France; (4) Tartu Ulikool, Estonia; (5) Consorzio per Valutazioni Biologiche e Farmacologiche, Italy; (6) The University of Liverpool, UK; (7) Therakind Ltd, UK; (8) Ospedale Pediatrico Bambino Gesú, Italy; (9) Servicio Madrileno de Salud, Spain; (10) AristotelioPanepistimioThessalonikis, Greece; (11) The University of Edinburg, UK; (12) SynapseResearch Management Partners SL, Spain.