ZETEZE ezetimibe/atorvastatin 10mg/20mg tablet blister pack

Active ingredient:

atorvastatin calcium trihydrate, Quantity: 21.7 mg (Equivalent: atorvastatin, Qty 20 mg); ezetimibe, Quantity: 10 mg

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

atorvastatin calcium trihydrate,Ezetimibe

Pharmaceutical form:

Tablet, multilayer

Composition:

Excipient Ingredients: polysorbate 80; magnesium stearate; povidone; lactose monohydrate; sodium lauryl sulfate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; hyprolose; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention of Cardiovascular Disease ZETEZE is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin 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 (see Clinical Trials). Primary Hypercholesterolaemia ZETEZE 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 atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe Homozygous Familial Hypercholesterolaemia (HoFH) ZETEZE is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).

Product summary:

Visual Identification: Capsule shaped, biconvex, white to off white tablets, with "333" debossed on one side of the tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-02-04