Core summary of product characteristics (SmPC) and package leaflet for fludeoxyglucose (18F) - Scientific guideline
This document describes the information to be included in the summary of product characteristics and package leaflet for fludeoxyglucose (18F).
Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core summary of product characteristic (SmPC), core package leaflet, fludeoxyglucose (18F)
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Guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F) (PDF/155.59 KB)
Adopted
First published: 14/08/2012
Last updated: 14/08/2012
EMA/CHMP/448228/2012 -
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Overview of comments on 'draft guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F)' (PDF/124.77 KB)
First published: 14/08/2012
Last updated: 14/08/2012
EMA/CHMP/448578/2012 -
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Draft guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F) (PDF/311.84 KB)
Draft: consultation closed
First published: 03/10/2011
Last updated: 03/10/2011
Consultation dates: 12/09/2011 to 31/12/2011
EMA/547466/2011