EU/3/12/1087: Orphan designation for the treatment of growth hormone deficiency
Recombinant modified human growth hormone
Table of contents
Overview
On 24 January 2013, orphan designation (EU/3/12/1087) was granted by the European Commission to Richardson Associates Regulatory Affairs Ltd, United Kingdom, for recombinant modified human growth hormone for the treatment of growth-hormone deficiency.
The sponsorship was transferred to Richardson Associates Regulatory Affairs Ltd, Ireland, in December 2018.
The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in April 2020.
Recombinant modified human growth hormone has been authorised in the EU as Ngenla since 14 February 2022.
This medicine is now known as somatrogon.
Key facts
Active substance |
Recombinant modified human growth hormone
|
Intended use |
Treatment of growth hormone deficiency
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/12/1087
|
Date of designation |
24/01/2013
|
Sponsor |
Pfizer Europe MA EEIG |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
The Committee for Orphan Medicinal Products reviewed the orphan designation of Ngenla 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: