Zonisamide Viatris [Zonisamide Mylan]

Medicinal product

(Invented) name

Zonisamide Viatris [Zonisamide Mylan]

Active substance (s)

Zonizamidas

Strength

25 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N03AX15, Zonisamide

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2016-03-31

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Zonizamidas	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
65676	80185	1080185	lizdinė plokštelė	N14		Receptinis	EU/1/16/1093/001	Netiekiama	-	-	No	-	-
65677	80186	1080186	lizdinė plokštelė	N28		Receptinis	EU/1/16/1093/002	Netiekiama	-	-	No	-	-
65678	80187	1080187	lizdinė plokštelė	N56		Receptinis	EU/1/16/1093/003	Netiekiama	-	-	No	-	-
65679	80188	1080188	dalomoji lizdinė plokštelė	N14x1		Receptinis	EU/1/16/1093/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-31	Registruotas