EU/3/09/635: Orphan designation for the treatment of systemic sclerosis

Treprostinil diethanolamine

Table of contents


On 15 May 2009, orphan designation (EU/3/09/635) was granted by the European Commission to United Therapeutics Europe Ltd, United Kingdom, for treprostinil diethanolamine for the treatment of systemic sclerosis.

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 diethanolamine
Intended use
Treatment of systemic sclerosis
Orphan designation status
EU designation number
Date of designation

United Therapeutics Ireland Limited
6th Floor
South Bank House
Barrow Street
Dublin 4
D04 TR29

Update history

Date Update
February 2023

The sponsorship was transferred from Unither Therapeutik GmbH, Germany, to United Therapeutics Ireland Limited, Ireland

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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