REZALTO 10 mg Film-coated tablet Ref.[115242] Active ingredients: Rivaroxaban

Source: Health Products Regulatory Authority (ZA)  Publisher: Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa, Tel: 0860287835

Product name and form

REZALTO 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink, round, biconvex film-coated tablets, engraved with “10” on one side, plain on the other.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg rivaroxaban.

Each film-coated tablet contains 95,6 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient

Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Croscarmellose sodium
Hypromellose
Lactose monohydrate
Magnesium stearate
Purified water
Sodium laurilsulfate

Film-coating:

Hypromellose 2910 (E464)
Titanium dioxide (E171)

Pack sizes and marketing

Tablets are packed in transparent PVC/Aluminium blister strips of 7 or 10, which are further packed in printed cartons, in pack sizes of 10 or 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa, Tel: 0860287835

Marketing authorization dates and numbers

REZALTO 10 mg: 53/8.2/0194

03 November 2020

Drugs

Drug Countries
REZALTO South Africa

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