EU/3/19/2213: Orphan designation for the treatment of growth hormone deficiency
lonapegsomatropin
Table of contents
Overview
On 17 October 2019, orphan designation EU/3/19/2213 was granted by the European Commission to Ascendis Pharma Endocrinology Division A/S, Denmark, for lonapegsomatropin for the treatment of growth hormone deficiency.
The sponsor’s address was updated in April 2021.
The medicinal product has been authorised in the EU as Lonapegsomatropin Ascendis Pharma since 11 January 2022.
Key facts
Active substance |
lonapegsomatropin
|
Intended use |
Treatment of growth hormone deficiency
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/19/2213
|
Date of designation |
17/10/2019
|
Sponsor |
Ascendis Pharma Endocrinology Division A/S |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of product 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: