Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in April 2014 on request of the Sponsor.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.
|Disease / condition||
Treatment of systemic sclerosis (scleroderma)
|Date of decision||
|Orphan decision number||
Sponsor's contact details
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;