Mayzent

Nazione: Unione Europea

Lingua: inglese

Fonte: EMA (European Medicines Agency)

Principio attivo:

Siponimod fumaric acid

Commercializzato da:

Novartis Europharm Limited 

Codice ATC:

L04

INN (Nome Internazionale):

siponimod

Gruppo terapeutico:

Selective immunosuppressants

Area terapeutica:

Multiple Sclerosis, Relapsing-Remitting

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Revision: 10

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2020-01-13

Foglio illustrativo

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

Scheda tecnica

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