EU/3/16/1794: Orphan designation for the diagnosis of gastrointestinal stromal tumours

68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2

Overview

On 12 December 2016 orphan designation (EU/3/16/1794) was granted by the European Commission to Advanced Accelerator Applications, France, for 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 (also known as 68Ga-NeoBOMB1) for the diagnosis of gastrointestinal stromal tumours.

Key facts

Active substance
68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2
Intended use
Diagnosis of gastrointestinal stromal tumours
Orphan designation status
Positive
EU designation number
EU/3/16/1794
Date of designation
12/12/2016
Sponsor
Advanced Accelerator Applications
20 rue Diesel
01630 Saint-Genis-Pouilly
France
Tel. +33 4 50 99 30 76
E-mail: Regulatory_Affairs@adacap.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

Patients' organisations

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

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

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

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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