Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator - Scientific guideline

HumanScientific guidelines

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This document describes the information to be included in the summary of products characteristics and package leaflet for (68Ge/68Ga) generator.

Keywords: Radiopharmaceuticals, radionuclide, kit for radiopharmaceutical preparation, core SmPC, core package leaflet, gallium68, germanium68, generator

Current effective version

Guideline on core SmPC and Package Leaflet for (68Ge/68Ga) generator - First version

Adopted Reference Number: EMA/CHMP/337681/2016 Legal effective date: Summary:

This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for (68Ge/68Ga) generator.

English (EN) (530.31 KB - PDF)

Публикувано за първи път: Последна актуализация:
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Document history

Draft guideline on the development of new medicinal products for the treatment of Crohn's disease

Draft: consultation closed Reference Number: CPMP/EWP/2284/99 Rev. 1

English (EN) (103.54 KB - PDF)

Публикувано за първи път: Последна актуализация:
Виж

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