EZESTAT COMPOSITE PACK (Pharmacor Pty Ltd)
Product name
EZESTAT COMPOSITE PACK
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
123 (255 working days)
Active ingredients
Ezetimibe, Rosuvastatin calcium
Registration type
New generic medicine
Indication
Primary Hypercholesterolaemia
EZESTAT COMPOSITE PACK is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients:
- not appropriately controlled with rosuvastatin or ezetimibe alone; or
- already treated with rosuvastatin and ezetimibe
Homozygous Familial Hypercholesterolaemia (HoFH)
EZESTAT COMPOSITE PACK is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).