EU/3/15/1450: Orphan designation for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours

Gallium (68Ga)-edotreotide


On 19 March 2015, orphan designation (EU/3/15/1450) was granted by the European Commission to Advanced Accelerator Applications SA, France, for gallium (68Ga)-edotreotide for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours.

In September 2016, Advanced Accelerator Applications SA changed name to Advanced Accelerator Applications.

Gallium (68Ga)-edotreotide has been authorised in the EU as SomaKit TOC since 8 December 2016.

Key facts

Active substance
Gallium (68Ga)-edotreotide
Medicine name
SomaKit TOC
Intended use
Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Orphan designation status
EU designation number
Date of designation

Advanced Accelerator Applications
8 Rue Henri Sainte Claire Deville
92500 Rueil-Malmaison

Review of designation

On 14 October 2016, the Committee for Orphan Medicinal Products (COMP) completed a review of the designation EU/3/15/1450 for SomaKit TOC (edotreotide, for use after radiolabelling as gallium (68Ga)-edotreotide) as an orphan medicinal product for the diagnosis of gastroenteropancreatic neuroendocrine tumours (GEP-NET). The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of diagnosis. As other methods of diagnosis are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with GEP-NET. The COMP recommended that the orphan designation of the medicine be maintained1.

1The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.

Update history

May 2023The sponsor’s address was updated.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: SomaKit TOC (edotreotide) for the diagnosis of gastroenteropancreatic neuroendocrine tumours (PDF/80.65 KB)


    First published: 20/02/2017
    Last updated: 20/02/2017

  • Patients' organisations

    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

    • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

    • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

    EU register of orphan medicines

    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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