EU/3/18/2130: Orphan designation for the treatment of pulmonary arterial hypertension
Ralinepag
Table of contents
Overview
On 11 January 2019, orphan designation (EU/3/18/2130) was granted by the European Commission to Arena Pharmaceuticals Limited, Ireland, for ralinepag for the treatment of pulmonary arterial hypertension.
The sponsorship was transferred to Unither Therapeutik GmbH, Germany in April 2019.
The sponsor's address was updated in July 2021.
Key facts
Active substance |
Ralinepag
|
Intended use |
Treatment of pulmonary arterial hypertension
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/18/2130
|
Date of designation |
11/01/2019
|
Sponsor |
United Therapeutics Ireland Limited |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Update history
Date | Update |
---|---|
January 2023 | The sponsorship was transferred from Unither Therapeutik GmbH, Germany, to United Therapeutics Ireland Limited, Ireland |
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: