EU/3/18/2068: Orphan designation for the treatment of growth hormone deficiency
Table of contents
On 24 August 2018, orphan designation (EU/3/18/2068) was granted by the European Commission to Novo Nordisk A/S, Denmark, for somapacitan for the treatment of growth hormone deficiency.
Somapacitan has been authorised in the EU as Sogroya since 31 March 2021.
Treatment of growth hormone deficiency
|Orphan designation status||
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Novo Nordisk A/S
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Somapacitan at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the orphan medicine assessment report .
Documents related to this orphan designation evaluation
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: