EU/3/05/310: Orphan designation for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

Treprostinil diethanolamine

Table of contents

Overview

On 26 August 2005, orphan designation (EU/3/05/310) was granted by the European Commission to United Therapeutics Europe Ltd., United Kingdom, for treprostinil diethanolamine (oral use) for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Key facts

Active substance
Treprostinil diethanolamine
Intended use
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Orphan designation status
Positive
EU designation number
EU/3/05/310
Date of designation
26/08/2005
Sponsor

Gran Via Carlos III 94
08028 Barcelona
Spain
Email: egil@ferrer.com

Update history

DateUpdate
January 2022The sponsorship was transferred to Ferrer Internacional S.A., Spain.
July 2021The sponsor's address was updated.
February 2019The sponsorship was transferred to Unither Therapeutik GmbH, Germany.

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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