MYTANTEN (Nova Pharmaceuticals Australasia Pty Ltd)
Product name
MYTANTEN
Date registered
Evaluation commenced
Decision date
Approval time
116 (255 working days)
Active ingredients
Macitentan
Registration type
New generic medicine
Indication
[TRADENAME], as monotherapy or in combination with approved PAH treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), 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.