EU/3/13/1170: Orphan designation for the treatment of acromegaly
Table of contents
On 5 August 2013, orphan designation (EU/3/13/1170) was granted by the European Commission to Larode Ltd, United Kingdom, for octreotide acetate (oral use) for treatment of acromegaly.
The sponsorship was transferred to FGK Representative Service GmbH, Germany, in January 2019.
The sponsorship was transferred to Amryt Pharmaceuticals Designated Activity Company, Ireland in February 2022.
The medicinal product has been authorised in the EU as Mycapssa since 2 December 2022.
Treatment of acromegaly
|Orphan designation status||
|EU designation number||
|Date of designation||
Amryt Pharmaceuticals Designated Activity Company
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Mycapssa 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: