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

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

Current effective version

Guideline on core SmPC and package leaflet for sodium iodide (131I) for therapeutic use

Adopted Reference Number: EMA/CHMP/630248/2017

Document history

Submission of comments on 'Guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule' (EMA/CHMP/649301/2016)

Reference Number: EMA/630247/2017

Draft guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule

Draft: consultation closed Consultation dates: 26/04/2017 to 31/08/2017 Reference Number: EMA/CHMP/649301/2016 Summary:

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and package leaflet for sodium iodide (131I) therapy capsule.