SomaKit TOC

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edotreotide

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 04/09/2017

Authorisation details

Product details
Name
SomaKit TOC
Agency product number
EMEA/H/C/004140
Active substance
edotreotide
International non-proprietary name (INN) or common name
edotreotide
Therapeutic area (MeSH)
  • Neuroendocrine Tumors
  • Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
V09IX
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

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

Publication details
Marketing-authorisation holder
Advanced Accelerator Applications
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
08/12/2016
Contact address
20 rue Diesel
01630 Saint Genis Pouilly
France

Product information

12/06/2017 SomaKit TOC - EMEA/H/C/004140 - IB/0003

Contents

  • 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.

Pharmacotherapeutic group

DIAGNOSTIC RADIOPHARMACEUTICALS

Therapeutic indication

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.

Assessment history

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