EU/3/04/197:

Treprostinil sodium

Table of contents

Overview

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.

Key facts

Active substance
Treprostinil sodium
Intented use
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation
14/04/2004
Orphan designation status
Positive
EU designation number
EU/3/04/197

Sponsor's contact details

Unither Therapeutik GmbH
Dieselstrasse 42
Offenbach Am Main 63071
Hassia
Germany
Tel: +49 69 98535179

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

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