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

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/167834/2011
Published23/09/2011
Effective from03/10/2011
KeywordsRadiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core summary of product characteristics (SmPC), core package leaflet
DescriptionThis document describes the information to be included in the summary of product characteristics and package leaflet for radiopharmaceuticals.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 03/10/2011–present


Published: 03/10/2011


Published: 30/03/2011

Superseded document PDF iconCore SmPC Published: 29/07/2010
Superseded document PDF iconCore package leaflet Published: 29/07/2010


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