Please note that this product was withdrawn from the Community register of designated orphan medicinal products in March 2013 on request of the sponsor.
On 21 October 2004, orphan designation (EU/3/04/234) was granted by the European Commission to PPD Global Ltd, UK, for sitaxentan sodium for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
The sponsorship was transferred to Encysive (UK) Ltd, United Kingdom, in July 2005 and to Pfizer Limited, United Kingdom, in September 2010.
Sitaxentan sodium was authorised in the EU as Thelin on 10 August 2006.
The marketing authorisation was withdrawn on 10 December 2010.
EU/3/04/234: Public summary of positive opinion for orphan designation of sitaxentan sodium for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (PDF/144.45 KB)
First published: 28/02/2007
Last updated: 30/09/2016
EMEA/COMP/69492/04 Rev. 3
|Disease / condition||
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
|Date of first decision||
|EU designation number||
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.