EU/3/16/1794
Table of contents
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
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.