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

This document describes the information to be included in the summary of products characteristics and package leaflet for gadoteric acid.

Keywords: Magnetic resonance, contrast media, gadolinium compounds, core SmPC, core package leaflet, gadoteric acid

Current effective version

Draft guideline on core SmPC and package leaflet for gadoteric acid

Draft: consultation closed Consultation dates: 01/06/2016 to 30/09/2016 Reference Number: EMA/CHMP/337820/2016 Summary:

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