Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Mayzent 0.25 mg film-coated tablets.
Mayzent 1 mg film-coated tablets.
Mayzent 2 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Mayzent 0.25 mg film-coated tablets: Pale red, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “T” on the other side. Mayzent 1 mg film-coated tablets: Violet white, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “L” on the other side. Mayzent 2 mg film-coated tablets: Pale yellow, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “II” on the other side. |
Each film-coated tablet contains siponimod fumaric acid equivalent to 0.25 mg siponimod.
Excipient with known effect: Each tablet contains 59.1 mg lactose (as monohydrate) and 0.092 mg soya lecithin.
Each film-coated tablet contains siponimod fumaric acid equivalent to 1 mg siponimod.
Excipient with known effect: Each tablet contains 58.3 mg lactose (as monohydrate) and 0.092 mg soya lecithin.
Each film-coated tablet contains siponimod fumaric acid equivalent to 2 mg siponimod.
Excipient with known effect: Each tablet contains 57.3 mg lactose (as monohydrate) and 0.092 mg soya lecithin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Siponimod |
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 |
|---|
Mayzent 0.25 mg film-coated tabletsTablet core: Lactose monohydrate Tablet coating: Polyvinyl alcohol Mayzent 1 mg film-coated tabletsTablet core: Lactose monohydrate Tablet coating: Polyvinyl alcohol Mayzent 2 mg film-coated tabletsTablet core: Lactose monohydrate Tablet coating: Polyvinyl alcohol |
Mayzent 0.25 mg film-coated tablets:
Titration packs of 12 film-coated tablets in PA/alu/PVC/alu blister in wallet.
Packs of 84 or 120 film-coated tablets in PA/alu/PVC/alu blisters.
Mayzent 1 mg film-coated tablets:
Packs of 28 or 98 film-coated tablets in PA/alu/PVC/alu blisters.
Mayzent 2 mg film-coated tablets:
Packs of 14, 28 or 98 film-coated tablets in PA/alu/PVC/alu blisters.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Mayzent 0.25 mg film-coated tablets:
EU/1/19/1414/001
EU/1/19/1414/002
EU/1/19/1414/004
Mayzent 1 mg film-coated tablets:
EU/1/19/1414/007
EU/1/19/1414/008
Mayzent 2 mg film-coated tablets:
EU/1/19/1414/003
EU/1/19/1414/005
EU/1/19/1414/006
13 January 2020
| Drug | Countries | |
|---|---|---|
| MAYZENT | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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