PUMA (Paediatric use marketing authorisation)
The Paediatric use marketing authorisation (PUMA) is a new type of marketing authorisation.
PUMA can be used for each already authorised medicinal product in adults. PUMA will utilise existing marketing authorisation procedures but is specified for medicinal products developed exclusively for use in children. This includes paediatric indications in all or subsets of the paediatric population and / or the development of appropriate strength, pharmaceutical form or route of administration. The development has to be in line with the agreed PIP by the PDCO.