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.
Recombinant modified human growth hormone
Treatment of growth hormone deficiency
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Review of designation
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: