BIVALIRUDIN ANS (Southern XP IP Pty Ltd)
Product name
BIVALIRUDIN ANS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
127 (255 working days
Active ingredients
bivalirudin
Registration type
New generic medicine
Indication
BIVALIRUDIN SXP, BIVALIRUDIN HMH, BIVALIRUDIN ANS 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).
BIVALIRUDIN SXP, BIVALIRUDIN HMH, BIVALIRUDIN ANS is intended for use with aspirin.
A P2Y12 antagonist (eg clopidogrel or ticlopidine) may be used in addition to aspirin.