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

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

Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core summary of product characteristic (SmPC), core package leaflet, fludeoxyglucose (¹⁸F)

Current effective version

Guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F)

Adopted Reference Number: EMA/CHMP/448228/2012 Summary:

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for fludeoxyglucose (18F).

Document history - First version

Guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F)

Adopted Reference Number: EMA/CHMP/448228/2012 Summary:

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for fludeoxyglucose (18F).

Overview of comments on 'draft guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F)'

Reference Number: EMA/CHMP/448578/2012

Draft guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F)

Draft: consultation closed Consultation dates: 12/09/2011 to 31/12/2011 Reference Number: EMA/547466/2011 Summary:

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for Fludeoxyglucose (18F).

Document history - Superseded document

Core summary of product characteristics (SmPC) for fludeoxyglucose

Document history - Superseded document

Package leaflet: information for the patient: Fludeoxyglucose