Suche Orphan Drug
Marktzulassung mit Orphan-Drug-Designation - USA
- Produkt: TRACLEER
- ATC-Code : C02KX01
- EU-Nummer: -
- MA date : 20/11/2001
- Zulassungsinhaber: ACTELION PHARMACEUTICALS LTD.
Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
- in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients withWHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases(21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).
- in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.