Mayzent

Medicinal product

(Invented) name

Mayzent

Active substance (s)

Siponimodas

Strength

0,25 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AE03, siponimod

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2020-01-13

Date of renewal

Documents

Mayzent gydytojo zymimas kontrolinis sarasas.pdf

Mayzent vadovas pacientui ir globejui.pdf

Mayzent nėštumo priminimo kortelė.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Siponimodas	0,25 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
103178	89279	1089279	lizdinė plokštelė	N12 (titravimo pak.)		Receptinis	EU/1/19/1414/001	Tiekiama	-	-	No	-	-
103179	89280	1089280	lizdinė plokštelė	N120		Receptinis	EU/1/19/1414/002	Netiekiama	-	-	No	-	-
103516	89618	1089618	lizdinė plokštelė	N84		Receptinis	EU/1/19/1414/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-13	Registruotas