TICAGRELOR SANDOZ (Sandoz Pty Ltd)
Product name
TICAGRELOR SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
139 (255 working days)
Active ingredients
ticagrelor
Registration type
New generic medicine
Indication
Ticagrelor Sandoz, in combination with aspirin, is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in adult patients with acute coronary syndromes (unstable angina [UA], non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]) including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine