paediatric-use marketing authorisation

A type of marketing authorisation covering the indication(s) and appropriate formulation(s) for the paediatric population, which was introduced by the Paediatric Regulation. Applicants can request paediatric-use marketing authorisations for medicines that are already authorised, are no longer covered by a supplementary protection certificate or a patent that qualifies as such and are developed exclusively for use in children.

Abbreviated as PUMA.

More information can be found under 'Paediatric-use marketing authorisations'.