Core summary of product characteristics (SmPC) and package leaflet for fluorodopa (18F) - Scientific guideline

This document describes the information to be included in the summary of products characteristics and package leaflet for fluorodopa (18F).

Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core SmPC, core package leaflet, fluorodopa, 18F, fluorodopa (18F)

Current effective version

Draft guideline on core SmPC and package leaflet for fluorodopa (18F)

Draft: consultation closed Consultation dates: 01/06/2016 to 30/09/2016 Reference Number: EMA/CHMP/337958/2016 Summary:

This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for fluorodopa (18F).