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.
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
Treprostinil sodium (inhalation use)
|Disease / condition||
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
|Date of first decision||
|EU designation number||
Sponsor's contact details
Unither Therapeutik GmbH
Tel. +49 6105 27137
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