Core summary of product characteristics (SmPC) and package leaflet for radiopharmaceuticals - Scientific guideline

This document describes the information to be included in the summary of product characteristics and package leaflet for radiopharmaceuticals.

Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core summary of product characteristics (SmPC), core package leaflet

Current effective version

Guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals

Adopted Reference Number: EMA/CHMP/167834/2011 Legal effective date: 23/09/2011 Summary:

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

Document history

Overview of comments on 'Draft guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals'

Reference Number: EMA/358709/2011

Draft guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals

Draft: consultation closed Consultation dates: 17/03/2011 to 25/04/2011 Reference Number: EMA/CHMP/167834/2011

Core summary of product characteristics for Radiopharmaceuticals

Reference Number: EMA/CHMP/EWP/430004/2010

Package leaflet: information for the patient: Fludeoxyglucose