This is a summary of the European public assessment report (EPAR) for SomaKit TOC. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use SomaKit TOC.
For practical information about using SomaKit TOC, patients should read the package leaflet or contact their doctor or pharmacist.
SomaKit TOC : EPAR - Summary for the public (PDF/77.63 KB)
First published: 20/02/2017
Last updated: 20/02/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Advanced Accelerator Applications
|Date of issue of marketing authorisation valid throughout the European Union||
17/12/2018 SomaKit TOC - EMEA/H/C/004140 - N/0009
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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This medicinal product is for diagnostic use only.
After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.