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BOSENTAN CIPLA, BOSENTAS, BOSENCIP (Cipla Australia Pty Ltd)
Product name
BOSENTAN CIPLA, BOSENTAS, BOSENCIP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
165 working days (255)
Active ingredients
bosentan (as monohydrate)
Registration type
New generic medicine
Indication
BOSENTAN CIPLA, BOSENTAS, BOSENCIP (tablets) is indicated for the treatment of:
- idiopathic pulmonary arterial hypertension;
- familial pulmonary arterial hypertension;
- pulmonary arterial hypertension associated with scleroderma; or
- pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology
in patients with WHO functional Class II, III or IV symptoms.