MAYZENT FILM-COATED TABLET 0.25MG

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Siponimod fumaric acid equiv siponimod

제공처:

NOVARTIS (SINGAPORE) PTE LTD

ATC 코드:

L04AA42

약제 형태:

TABLET, FILM COATED

구성:

Siponimod fumaric acid equiv siponimod 0.25mg

관리 경로:

ORAL

처방전 유형:

Prescription Only

Manufactured by:

NOVARTIS PHARMA STEIN AG

승인 상태:

ACTIVE

승인 날짜:

2020-11-16

제품 특성 요약

Mayzent Dec2022.SINv1
Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Mayzent 0.25 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 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 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.
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 relapses or imaging features
of inflammatory activity (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Before initiation of treatment, patients must be genotyped for CYP2C9
to determine their CYP2C9
metaboliser status (see sections 4.4, 4.5 and 5.2).
In patients with a CYP2C9*3*3 genotype, Mayzent should not be used
(see sections 4.3, 4.4 and 5.2).
Mayzent Dec2022.SINv1
Page 2 of 22
In patients with a CYP2C9*2*3 or *1*3 genotype, the recommended
maintenance dose is 1 mg taken
once daily (four tablets of 0.25 mg) (see sections 4.4 and 5.2).
The recommended maintenance dose of Mayzent in all other CYP2C9
genotype patients is 2 mg.
Mayzent is taken once daily.
Posology
_Treatment initiation _
Treatment has