Please note that this product was withdrawn from the Community register of designated orphan medicinal products in May 2012 at the end of the period of market exclusivity.
On 14 February 2001, orphan designation (EU/3/01/019) was granted by the European Commission to Actelion Pharmaceuticals, France, for bosentan for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
The sponsorship was transferred to Actelion Registration Limited, United Kingdom in July 2001.
Bosentan for treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension has been authorised in the EU as Tracleer since 15 May 2002.
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
|Orphan designation status||
|EU designation number||
|Date of designation||
Actelion Registration Limited
Chiswick Tower 13th floor
389 Chiswick High Road
London W4 4AL
Tel. + 44 (0)20 8987 3320
Fax + 44 (0)20 8987 3322
Documents related to this orphan designation evaluation
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.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: