EZETIMIBE - ROSUVASTATIN SANDOZ (Sandoz Pty Ltd)
Product name
EZETIMIBE - ROSUVASTATIN SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
Rosuvastatin calcium, Ezetimibe
Registration type
New generic medicine
Indication
Primary Hypercholesterolaemia
EZETIMIBE - ROSUVASTATIN SANDOZ 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)