MACITENTAN-MSN (Accelagen Pty Ltd)
Product name
MACITENTAN-MSN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
Macitentan
Registration type
New generic medicine
Indication
[TRADE NAME], as monotherapy is indicated for the treatment of:
- idiopathic pulmonary arterial hypertension
- heritable pulmonary arterial hypertension
- pulmonary arterial hypertension associated with connective tissue disease
- pulmonary arterial hypertension associated with congenital heart disease with repaired shunts in patients with WHO Functional class II, III or IV symptoms.