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

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Current effective version

Adopted 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

Adopted guideline


Overview of comments


Draft guideline

In operation: 03/10/2011–present


Published: 03/10/2011


Published: 30/03/2011

Superseded documentCore SmPCPublished: 29/07/2010
Superseded documentCore package leafletPublished: 29/07/2010


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