Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: bosentan
Active substance: bosentan
Indication: Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:
• Primary (idiopathic and heritable) pulmonary arterial hypertension
• Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
• Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology
Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II.
Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/09/2015 PSUSA - Modification EMEA/H/C/PSUSA/425/201411 (2015)6117 of 28/08/2015
07/10/2016 PSUSA - Modification EMEA/H/C/PSUSA/425/201511 (2016)6543 of 06/10/2016
19/09/2017 PSUSA - Modification EMEA/H/C/PSUSA/425/201611 (2017) 6435 of 18/09/2017