ROXALEM rivaroxaban 20 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rivaroxaban, Quantity: 20 mg

Available from:

Alembic Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; croscarmellose sodium; magnesium stearate; lactose monohydrate; microcrystalline cellulose; poloxamer; titanium dioxide; macrogol 8000; iron oxide red; iron oxide black

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rivaroxaban is indicated for:,? Prevention of venous thromboembolism (VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks),? Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke,? Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE,Rivaroxaban, in combination with aspirin, is indicated for:,? The prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD)

Product summary:

Visual Identification: Round shaped, brown to dark brown, film-coated biconvex tablets debossed with 20 on one side and I on the other side. Approximately 6 mm in diameter and 3.40 mm in thickness.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 6 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-10-03