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
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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: