APO-PRASUGREL, PRASUGREL AJS, PRASUGREL SCP, PRASUGREL TLB (Southern Cross Pharma Pty Ltd)
Product name
APO-PRASUGREL, PRASUGREL AJS, PRASUGREL SCP, PRASUGREL TLB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
163 working days (255)
Active ingredients
prasugrel
Registration type
New generic medicine
Indication
APO-PRASUGREL, PRASUGREL AJS, PRASUGREL SCP, PRASUGREL TLB (film-coated tablet), co-administered with aspirin, are indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (UA), non ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI)) who are to undergo percutaneous coronary intervention (PCI).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine