Table of contents


Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in April 2014 on request of the Sponsor.

The sponsorship was transferred to Actelion Registration Limited, United Kingdom in July 2001.

On 17 March 2003, orphan designation (EU/3/03/139) was granted by the European Commission to Actelion Registration Limited, United Kingdom, for bosentan for the treatment of systemic sclerosis.

Bosentan for treatment of systemic sclerosis has been authorised in the EU as Tracleer since 7 June 2007.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Medicine name
Disease / condition
Treatment of systemic sclerosis (scleroderma)
Date of first decision
EU designation number

Sponsor's contact details

Actelion Registration Limited
Chiswick Tower 13th floor
389 Chiswick High Road
London W4 4AL
United Kingdom
Tel. + 44 (0)20 8987 3320
Fax + 44 (0)20 8987 3322

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.

How useful was this page?

Add your rating