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VAZKEPA (AA-Med Pty Ltd)
Product name
VAZKEPA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
157 (255 working days)
Active ingredients
icosapent ethyl
Registration type
NCE/NBE
Indication
VAZKEPA is indicated to reduce the risk of cardiovascular events in adult statin- treated patients at high cardiovascular risk with elevated triglycerides (≥ 1.7 mmol/L) and
- established cardiovascular disease, or
- diabetes, and at least one other cardiovascular risk factor.