Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Novartis SA (Pty) Ltd., Magwa Crescent West, Waterfall City, Johannesburg, 2090
KIENDRA 0.25 mg film-coated tablets.
KIENDRA 2 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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KIENDRA 0.25 mg: Pale red, round, biconvex, beveled-edged film-coated tablet with Novartis logo on one side and T on other side. KIENDRA 2 mg: Pale yellow, round, biconvex, beveled-edged film-coated tablet with Novartis logo on one side and II on other side. |
KIENDRA 0.25 mg film-coated tablet contains 0,278 mg siponimod fumaric acid equivalent to 0,25 mg siponimod. Contains sugar: 62,2 mg lactose (as monohydrate) per tablet.
KIENDRA 2 mg film-coated tablet contains 2,224 mg siponimod fumaric acid equivalent to 2 mg siponimod. Contains sugar: 60,3 mg lactose (as monohydrate) per tablet.
For the full list of excipients see Section 6.1.
| Active Ingredient |
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Siponimod is a sphingosine-1-phosphate (S1P) receptor modulator. By acting as a functional antagonist on S1P1 receptors on lymphocytes, siponimod prevents egress from lymph nodes. This reduces the recirculation of T cells into the central nervous system (CNS) to limit central inflammation. Siponimod is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease. |
| List of Excipients |
|---|
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Lactose monohydrate Each 0.25 mg tablet contains 62.2 mg lactose monohydrate. Each 2 mg tablet contains 60.3 mg lactose monohydrate. Tablet coating: Polyvinyl alcohol |
KIENDRA 0,25 mg film-coated tablets in blisters composed of PA/AL/PVC-AL blister packs. Pack sizes: 12 or 120 tablets per pack.
KIENDRA 2 mg film-coated tablets in blisters composed of PA/AL/PVC-AL blister packs. Pack sizes: 28 tablets per pack.
Novartis SA (Pty) Ltd., Magwa Crescent West, Waterfall City, Johannesburg, 2090
KIENDRA 0.25 mg: 54/34/0653
KIENDRA 2 mg: 54/34/0654
08 April 2021
| Drug | Countries | |
|---|---|---|
| KIENDRA | South Africa |
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