Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Siponimod fumaric acid
Novartis Europharm Limited
L04
siponimod
Selective immunosuppressants
Multiple Sclerosis, Relapsing-Remitting
Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.
Revision: 10
Authorised
2020-01-13
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Mayzent 0.25 mg film-coated tablets Mayzent 1 mg film-coated tablets Mayzent 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mayzent 0.25 mg film-coated tablets 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. Mayzent 1 mg film-coated tablets 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. Mayzent 2 mg film-coated tablets 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. 3. 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. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by r Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Mayzent 0.25 mg film-coated tablets Mayzent 1 mg film-coated tablets Mayzent 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mayzent 0.25 mg film-coated tablets 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. Mayzent 1 mg film-coated tablets 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. Mayzent 2 mg film-coated tablets 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. 3. 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. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by r Read the complete document