EU/3/14/1237: Orphan designation for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours

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

Overview

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
Intended use
Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Orphan designation status
Positive
EU designation number
EU/3/14/1237
Date of designation
19/02/2014
Sponsor

Advanced Accelerator Applications
8 Rue Henri Sainte Claire Deville
92500 Rueil-Malmaison
France
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.

Update history

DateUpdate
May 2023The sponsor’s address was updated.

Documents related to this orphan designation evaluation

Patients' organisations

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

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

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

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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