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NEXLIZET Seqirus Pty Ltd
Product name
NEXLIZET
Sponsor
Accepted date
Sep-2025
Active ingredients
Bempedoic acid, ezetimibe
Proposed indication
Nexlizet (bempedoic acid and cezetimibe) is proposed to treat adults with high cholesterol or mixed lipid problems. Along with dietary measures it may be:
-combined with a statin when statin plus ezetimibe does not lower LDL cholesterol.
-used alone for people who can’t take statins and where LDL is not decreasing with ezetimibe.
-given to patients already taking bempedoic acid and ezetimibe as separate tablets, with or without a statin.
Nexlizet (bempedoic acid andcezetimibe) is also proposed to treat adults, with heart disease or at high risk of it, to lower bad cholesterol (LDL-C) and reduce heart problems. It’s proposed to be added to treatment when:
-statins and ezetimibe do not reduce LDL levels sufficently.
-statins can’t be used, and ezetimibe alone do not reduce LDL levels sufficently.
-bempedoic acid and ezetimibe are already taken as separate tablets.
-combined with a statin when statin plus ezetimibe does not lower LDL cholesterol.
-used alone for people who can’t take statins and where LDL is not decreasing with ezetimibe.
-given to patients already taking bempedoic acid and ezetimibe as separate tablets, with or without a statin.
Nexlizet (bempedoic acid andcezetimibe) is also proposed to treat adults, with heart disease or at high risk of it, to lower bad cholesterol (LDL-C) and reduce heart problems. It’s proposed to be added to treatment when:
-statins and ezetimibe do not reduce LDL levels sufficently.
-statins can’t be used, and ezetimibe alone do not reduce LDL levels sufficently.
-bempedoic acid and ezetimibe are already taken as separate tablets.
Application type
B (new combination)
Publication date
Sep-2025