EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE (Alphapharm Pty Ltd)
Product name
EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
ezetimibe; simvastatin
Registration type
New generic medicine
Indication
Primary Hypercholesterolaemia
EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE (tablet) is indicated 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)
EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).