EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE (Alphapharm Pty Ltd)
Product name
EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
97 (255 working days)
Active ingredients
ezetimibe
Registration type
New generic medicine
Indication
Primary Hypercholesterolaemia
EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE (tablet) administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.
Homozygous Familial Hypercholesterolaemia (HoFH)
EZETIMIBE ALPHAPHARM,MYLAN-EZETIMIBE administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Homozygous Sitosterolaemia (Phytosterolaemia)
EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.