EU/3/16/1794

About

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
Disease / condition
Diagnosis of gastrointestinal stromal tumours
Date of first decision
12/12/2016
Outcome
Positive
EU designation number
EU/3/16/1794

Review of designation

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

Sponsor's contact details

Advanced Accelerator Applications
20 rue Diesel
01630 Saint-Genis-Pouilly
France
Tel. +33 4 50 99 30 76
E-mail: Regulatory_Affairs@adacap.com

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.

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