EU/3/09/635

Table of contents

About

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.

Key facts

Active substance
Treprostinil diethanolamine
Disease / condition
Treatment of systemic sclerosis
Date of first decision
15/05/2009
Outcome
Positive
EU designation number
EU/3/09/635

Sponsor's contact details

Unither Therapeutik GmbH
Dreieichstrasse 11
64546 Moerfelden-Walldorf
Germany
Tel. +49 6105 27137

Patients' organisations

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

  • Association des Sclérodermiques de France
    41 Rue du Pont de Fer
    28260 Sorel-Moussel
    France
    Telephone: +33 0820 620 615
    E-mail: association.asf@club-internet.fr
  • Raynaud's & Scleroderma Association (RSA)
    112 Crewe Road
    Alsager
    Cheshire ST7 2JA
    United Kingdom
    Telephone: +44 1270 872776
    Freephone: +44 800 9172494 (for UK enquiries only)
    Fax: +44 1270 883556
    Email: info@raynauds.org.uk
  • Sklerodermie Selbsthilfe e.V. 
    Am Wollhaus 2 
    74072 Heilbronn 
    Germany
    Telephone: +49 7131 3902425
    Telefax: +49 7131 3902426
    E-mail: sklerodermie@t-online.de

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