paediatric use marketing authorisation
- Guideline or reference source
- EMA Glossary of terms
- Definition
- 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 paedicatric-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.
- Abbreviation for
- PUMA
- Related Term
- class waiver
- paediatric-first development
- paediatric-only development
- paediatric committee
- product-specific waiver
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.