Source: Health Products Regulatory Authority (ZA) Publisher: Innovata Pharmaceuticals (Pty) LTD, Crownwood Office Park, 100 Northern Parkway, Ormonde, Johannesburg, 2091, South Africa
VARIXA 15, (FILM COATED TABLETS).
VARIXA 20, (FILM COATED TABLETS).
| Pharmaceutical Form |
|---|
|
Film coated tablets. VARIXA 15 round brown, biconvex film coated tablets, debossed with “504” on one side and plain on the other side. VARIXA 20 triangle shaped, brown, film coated tablets, debossed with “505” on one side and plain on the other side. |
Each VARIXA 15 film-coated tablet contains rivaroxaban 15 mg.
Contains sugar (lactose – 31.5 mg per 15 mg tablet).
Each VARIXA 20 film-coated tablet contains rivaroxaban 20 mg.
Contains sugar (lactose – 42.0 mg per 20 mg tablet).
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 |
|---|
|
VARIXA 15: Lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, opadry brown, titanium dioxide, macrogol/peg, iron oxide red, ferrosoferric oxide (NF) black. VARIXA 20: Lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, opadry brown, titanium dioxide, macrogol/peg, iron oxide red, ferrosoferric oxide (NF) black. |
VARIXA (rivaroxaban) film-coated tablets are available as follows: A carton containing aluminium foil and transparent PVC/PVDC blister strips containing 10 tablets each.
Innovata Pharmaceuticals (Pty) LTD, Crownwood Office Park, 100 Northern Parkway, Ormonde, Johannesburg, 2091, South Africa
29 MARCH 2022
| Drug | Countries | |
|---|---|---|
| VARIXA | South Africa |
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