CLOAP 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg uncoated tablet blister pack

Active ingredient:

aspirin, Quantity: 100 mg; clopidogrel hydrogen sulfate, Quantity: 97.87 mg (Equivalent: clopidogrel, Qty 75 mg)

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Aspirin,clopidogrel hydrogen sulfate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose; hydrogenated castor oil; microcrystalline cellulose; crospovidone; glycerol dibehenate; Colour

Administration route:

Oral

Units in package:

98, 14, 28, 280, 50, 4, 7, 100, 2, 84, 30, 112

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Clopidogrel/Aspirin is a fixed-dose combination product.,Clopidogrel/Aspirin is intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products: Unstable angina or non-ST elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Clopidogrel/Aspirin is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent); ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Clopidogrel/Aspirin has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

Product summary:

Visual Identification: Mottled purple, oval, biconvex tablets debossed 'CL7' on one face and 'S1' on the other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-10-27