Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator - Scientific guideline

This document describes the information to be included in the summary of products characteristics and package leaflet for (68Ge/68Ga) generator.

Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core SmPC, core package leaflet, gallium68, germanium68, generator

Current effective version

Guideline on core SmPC and Package Leaflet for (68Ge/68Ga) generator - First version

AdoptedReference Number: EMA/CHMP/337681/2016Legal effective date: 01/08/2017Summary:

This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for (68Ge/68Ga) generator.

Document history

Draft guideline on the development of new medicinal products for the treatment of Crohn's disease

Draft: consultation closedReference Number: CPMP/EWP/2284/99 Rev. 1