EU/3/14/1237

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

Advanced Accelerator Applications
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.

How useful was this page?

Add your rating