EPOPROSTENOL SUN (Sun Pharma ANZ Pty Ltd)
Product name
EPOPROSTENOL SUN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
168 working days (255)
Active ingredients
Epoprostenol sodium
Registration type
New generic medicine
Indication
EPOPROSTENOL SUN (powder for injection) is indicated for the long-term treatment, via continuous intravenous infusion, in WHO functional Class III or Class IV patients with:
- Idiopathic pulmonary arterial hypertension
- Familial pulmonary arterial hypertension
- Pulmonary arterial hypertension associated with the scleroderma spectrum of diseases.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine