EU/3/04/234

Table of contents

About

Please note that this product was withdrawn from the Community register of designated orphan medicinal products in March 2013 on request of the sponsor.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The marketing authorisation was withdrawn on 10 December 2010.

Key facts

Active substance
sitaxentan sodium
Medicine name
Thelin
Disease / condition
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of decision
21/10/2004
Outcome
Withdrawn
Orphan decision number
EU/3/04/234

Sponsor's contact details

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 0NJ
United Kingdom
Tel. +44 (0)1304 616161
Fax +44 (0)1304 652 144
E-mail: orphan_enquiries@pfizer.com

Patients' organisations

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.

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