EU/3/11/920: Orphan designation for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours

Gallium (68Ga)-pasireotide tetraxetan


On 27 October 2011, orphan designation (EU/3/11/920) was granted by the European Commission to OctreoPharm Sciences GmbH, Germany, for gallium (68Ga)-pasireotide tetraxetan for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours.

Key facts

Active substance
Gallium (68Ga)-pasireotide tetraxetan
Intended use
Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Orphan designation status
EU designation number
Date of designation
OctreoPharm Sciences GmbH
Robert-Roessle-Str. 10
13125 Berlin
Tel. +49 30 948 93360
Fax +49 30 948 93364

Review of designation

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

Documents related to this orphan designation evaluation

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.

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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