Source: Health Products Regulatory Authority (ZA) Publisher: Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa, Tel: 0860287835
REZALTO 15 mg film-coated tablets.
REZALTO 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. REZALTO 15 mg: Red, round, biconvex film-coated tablets, engraved with “15” on one side, plain on the other. REZALTO 20 mg: Brown-red round biconvex film coated tablets, engraved with “20” on one side, plain on the other. |
REZALTO 15 mg: Each film-coated tablet contains 15 mg rivaroxaban. Each film-coated tablet contains 16,32 mg lactose monohydrate.
REZALTO 20 mg: Each film-coated tablet contains 20 mg rivaroxaban. Each film-coated tablet contains 21,76 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 Film-coating: Hypromellose 2910 (E464) |
REZALTO 15 mg: Packed in PVC/Aluminium blisters in cartons of 10, 30 or 42 tablets.
REZALTO 20 mg: Packed in PVC/Aluminium blisters in cartons of 10, 30 or 42 tablets.
Not all pack sizes may be marketed.
Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa, Tel: 0860287835
REZALTO 15 mg: 53/8.2/0195
REZALTO 20 mg: 53/8.2/0196
03 November 2020
| Drug | Countries | |
|---|---|---|
| REZALTO | South Africa |
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