Core summary of product characteristics (SmPC) and package leaflet for radiopharmaceuticals - Scientific guideline
Table of contents
This document describes the information to be included in the summary of product characteristics and package leaflet for radiopharmaceuticals.
Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core summary of product characteristics (SmPC), core package leaflet
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Overview of comments on 'Draft guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals' (PDF/309.79 KB)
First published: 03/10/2011
Last updated: 03/10/2011
EMA/358709/2011 -
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Draft guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals (PDF/277.44 KB)
Draft: consultation closed
First published: 30/03/2011
Last updated: 30/03/2011
Consultation dates: 17/03/2011 to 25/04/2011
EMA/CHMP/167834/2011 -
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Core summary of product characteristics for Radiopharmaceuticals (PDF/89.8 KB)
First published: 29/07/2010
Last updated: 29/07/2010
EMA/CHMP/EWP/430004/2010 -
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Package leaflet: information for the patient: Fludeoxyglucose (PDF/93.9 KB)
First published: 14/12/2010
Last updated: 14/12/2010