Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use

Current version

PDF iconAdopted guideline

Reference numberEMA/CHMP/630248/2017
Published22/03/2018
Effective from16/01/2018
KeywordsRadiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core SmPC, core package leaflet, sodium iodide (131I), therapeutic use
DescriptionThis guideline describes the information to be included in the Summary of Product Characteristics (SmPC) and package leaflet for sodium iodide (131I) for therapeutic use.


Document history

First version

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation: 16/01/2018 - present

Published: 22/03/2018

Published: 22/02/2007

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