EU/3/18/2068: Orphan designation for the treatment of growth hormone deficiency
Somapacitan
Table of contents
Overview
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.
Key facts
Active substance |
Somapacitan
|
Intended use |
Treatment of growth hormone deficiency
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/18/2068
|
Date of designation |
24/08/2018
|
Sponsor |
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
.
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: