EU/3/04/197

Table of contents

About

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.

Key facts

Active substance
Treprostinil sodium (inhalation use)
Disease / condition
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of first decision
14/04/2004
Outcome
Positive
EU designation number
EU/3/04/197

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 HTAPFrance
    31 rue Jacques Cellier 
    F-51100 Reims
    France 
    Telephone : +33 3 26 36 93 32 
    E-mail : secretariat@htapfrance.com
  • Pulmonale Hypertonie 
    Kriegsstraße 25 
    D-76133 Karlsruhe
    Germany 
    Telephone: +49 721 352 83 81 
    Telefax: +49 721 352 88 80 
    E-mail: info@phev.de
  • Pulmonary Hypertension Association 
    PO Box 2760 
    Lewes 
    Sussex BN8 4WA
    United Kingdom 
    Telephone: +44 800 389 81 56 
    Telefax: (44-701) 071 57 23 
    E-mail: pha_uk@hotmail.com

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