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REPATHA (Amgen Australia Pty Ltd)
Product name
REPATHA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
183 working days (255)
Active ingredients
evolocumab
Registration type
EOI
Indication
REPATHA (solution for injection) is now indicated as an adjunct to diet and exercise in:
Prevention of Cardiovascular Events
REPATHA is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies.
Primary hypercholesterolaemia
REPATHA is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (LDL-C):
- in combination with a statin or statin with other lipid lowering therapies, or
- alone or in combination with other lipid-lowering therapies in patients who are statin intolerant.