On 14 April 2004, orphan designation (EU/3/04/197) was granted by the European Commission to LungRx Limited, United Kingdom, for treprostinil sodium (inhalation use) for the treatment of pulmonary artery hypertension and chronic thromboembolic pulmonary hypertension.
The sponsorship was transferred to United Therapeutics Europe Ltd, United Kingdom, in January 2008.
The sponsorship was transferred to Unither Therapeutik GmbH, Germany, in February 2019.
The sponsor's address was updated in July 2021.
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
|Orphan designation status||
|EU designation number||
|Date of designation||
|February 2023||The sponsorship was transferred from Unither Therapeutik GmbH, Germany, to United Therapeutics Ireland Limited, Ireland|
Documents related to this orphan designation evaluation
EU/3/04/197: Public summary of positive opinion for orphan designation of treprostinil sodium (inhalation use) for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (PDF/101.31 KB)
First published: 23/09/2009
Last updated: 23/09/2009
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: