PHARMACOR EZETIMIBE SIMVASTATIN, AKM-EZETIMIBE SIMVASTATIN (Pharmacor Pty Ltd)

PHARMACOR EZETIMIBE SIMVASTATIN, AKM-EZETIMIBE SIMVASTATIN (tablets) are indicated in adults (aged ≥18 years) for:

Prevention of Cardiovascular Disease

In patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

Primary Hypercholesterolaemia

As adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:

• Patients not appropriately controlled with a statin or ezetimibe alone.
• Patients already treated with a statin and ezetimibe.

Homozygous Familial Hypercholesterolaemia (HoFH)

In patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

PHARMACOR EZETIMIBE SIMVASTATIN, AKM-EZETIMIBE SIMVASTATIN (tablets) are also indicated Children and Adolescents (aged 10-17 years; pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche) for:

Heterozygous Familial Hypercholesterolaemia (HeFH)

As adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:

• Patients not appropriately controlled with a statin or ezetimibe alone.
• Patients already treated with a statin and ezetimibe.

Homozygous Familial Hypercholesterolaemia (HoFH)

In adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).