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

HumanScientific guidelines

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

AdoptedReference Number: EMA/CHMP/630248/2017

English (EN) (302.89 KB - PDF)

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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

English (EN) (438.63 KB - PDF)

First published: Last updated:
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Draft guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule

Draft: consultation closedConsultation dates: to Reference Number: EMA/CHMP/649301/2016Summary:

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

English (EN) (300.66 KB - PDF)

First published: Last updated:
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