Tracleer (bosentan)
- Region
- 🇪🇺 EU
- Active substance
- bosentan
- Status
- Authorised
- Therapeutic area
- Scleroderma, Systemic; Hypertension, Pulmonary
- CHMP opinion
- Thu 21 Feb 2002
- EU approval
- Tue 14 May 2002
- Application
- EMEA/H/C/000401
- ATC
- C02KX01
- Official record
- www.ema.europa.eu
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 familial) PAH; PAH secondary to scleroderma without significant interstitial pulmonary disease; PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. Some improvements have also been shown in patients with PAH 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Stayveer Authorised · Janssen-Cilag International NV
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.