Core summary of product characteristics and package leaflet for gadopentetate dimeglumine - Scientific guideline

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

Keywords: Magnetic resonance contrast media, gadolinium compounds, core summary of product characteristics (SmPC), core package leaflet, gadopentetate dimeglumine

Current effective version

Draft guideline on core SmPC and Package Leaflet for gadopentetate dimeglumine

Draft: consultation closedConsultation dates: 01/02/2016 to 30/04/2016Reference Number: EMA/CHMP/39163/2016Summary:

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and package leaflet for gadopentetate dimeglumine.