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
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Advanced Accelerator Applications
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12/06/2017 SomaKit TOC - EMEA/H/C/004140 - IB/0003
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.