EU/3/14/1237
Table of contents
About
On 19 February 2014, orphan designation (EU/3/14/1237) was granted by the European Commission to Advanced Accelerator Applications SA, France, for Gallium [Ga-68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic(2-7)disulfide for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours.
In September 2016, Advanced Accelerator Applications SA changed name to Advanced Accelerator Applications.
Key facts
Active substance |
Gallium [Ga-68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic(2-7)disulfide
|
Disease / condition |
Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
|
Date of first decision |
19/02/2014
|
Outcome |
Positive
|
EU designation number |
EU/3/14/1237
|
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. +33 450 993076
Fax +33 450 993071
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.