Mayzent

国: 欧州連合

言語: 英語

ソース: EMA (European Medicines Agency)

有効成分:

Siponimod fumaric acid

から入手可能:

Novartis Europharm Limited 

ATCコード:

L04

INN（国際名）:

siponimod

治療群:

Selective immunosuppressants

治療領域:

Multiple Sclerosis, Relapsing-Remitting

適応症:

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.

製品概要:

Revision: 10

認証ステータス:

Authorised

承認日:

2020-01-13

情報リーフレット

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

製品の特徴

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