Mayzent

Medicinal product

(Invented) name

Mayzent

Active substance (s)

Siponimodas

Strength

2 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 nėštumo priminimo kortelė.pdf

Mayzent gydytojo zymimas kontrolinis sarasas.pdf

Mayzent vadovas pacientui ir globejui.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	2 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
103180	89281	1089281	lizdinė plokštelė	N28		Receptinis	EU/1/19/1414/003	Tiekiama	-	-	No	-	-
104004	90109	1090109	lizdinė plokštelė	N14		Receptinis	EU/1/19/1414/005	Netiekiama	-	-	No	-	-
104005	90110	1090110	lizdinė plokštelė	N98		Receptinis	EU/1/19/1414/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-13	Registruotas