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BIVALIRUDIN MEDICIANZ (Medsurge Pharma Pty Ltd)
Product name
BIVALIRUDIN MEDICIANZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
140 (255 working days)
Active ingredients
bivalirudin
Registration type
New generic medicine
Indication
[TRADE NAME] is indicated for use as an anticoagulant:
- in the treatment of patients with moderate to high risk acute coronary syndromes(ACS) (unstable angina/non-ST segment elevation myocardial infarction(UA/NSTEMI) who are undergoing early invasive management, and
- in patients undergoing percutaneous coronary intervention (PCI).