CIP MACITENTAN (Cipla Australia Pty Ltd)
Product name
CIP MACITENTAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
134 (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.