On 5 August 2013, orphan designation (EU/3/13/1179) was granted by the European Commission to Larode Ltd, United Kingdom, for recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains for the treatment of growth-hormone deficiency.
This medicine is now known as somavaratan.
Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in December 2018 on request of the Sponsor.
EU/3/13/1179: Public summary of opinion on orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains for the treatment of growth-hormone deficiency (PDF/147.51 KB)
First published: 13/09/2013
Last updated: 24/03/2015
EMA/COMP/440859/2013 Rev. 1
Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan)
|Disease / condition||
Treatment of growth-hormone deficiency
|Date of decision||
|Orphan decision number||
Review of designation
Sponsor's contact details
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;