Mayzent

देश: यूरोपीय संघ

भाषा: अंग्रेज़ी

स्रोत: EMA (European Medicines Agency)

सक्रिय संघटक:

Siponimod fumaric acid

थमां उपलब्ध:

Novartis Europharm Limited 

ए.टी.सी कोड:

L04

INN (इंटरनेशनल नाम):

siponimod

चिकित्सीय समूह:

Selective immunosuppressants

चिकित्सीय क्षेत्र:

Multiple Sclerosis, Relapsing-Remitting

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

Revision: 10

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2020-01-13

सूचना पत्रक

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

उत्पाद विशेषताएं

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