EU/3/04/197: Orphan designation for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

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
Intended use
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Orphan designation status
Positive
EU designation number
EU/3/04/197
Date of designation
14/04/2004
Sponsor

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

Documents related to this orphan designation evaluation

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:

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