EZETIMIBE/SIMVASTATIN MSD 10 mg/10 mg ezetimibe 10 mg and simvastatin 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ezetimibe, Quantity: 10 mg; simvastatin, Quantity: 10 mg

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

Ezetimibe,Simvastatin

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: hypromellose; citric acid monohydrate; lactose monohydrate; microcrystalline cellulose; propyl gallate; croscarmellose sodium; magnesium stearate; butylated hydroxyanisole

Administration route:

Oral

Units in package:

10 Tablets, 5 Tablets, 30 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (greater than or equal to 18 years),Prevention of cardiovascular disease,EZETIMIBE/SIMVASTATIN MSD is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin 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 Section 5.1 Pharmacodynamic Properties, Clinical trials).,Primary hypercholesterolaemia,EZETIMIBE/SIMVASTATIN MSD 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 MSD is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Children and adolescents 10-17 years,(pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche) Heterozygous Familial Hypercholesterolaemia (HeFH),EZETIMIBE/SIMVASTATIN MSD is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia 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 MSD is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Product summary:

Visual Identification: White to off-white, capsule shaped, biconvex compressed tablet with "311" marked on the tablet; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-11-25