Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use - Scientific guideline
Table of contents
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) and package leaflet for sodium iodide (131I) for therapeutic use.
Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core SmPC, core package leaflet, sodium iodide (131I), therapeutic use
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Submission of comments on 'Guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule' (EMA/CHMP/649301/2016) (PDF/438.63 KB)
First published: 22/03/2018
Last updated: 22/03/2018
EMA/630247/2017 -
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Draft guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule (PDF/300.66 KB)
Draft: consultation closed
First published: 26/04/2017
Last updated: 26/04/2017
Consultation dates: 26/04/2017 to 31/08/2017
EMA/CHMP/649301/2016