Zonisamide Viatris [Zonisamide Mylan]

Medicinal product

(Invented) name

Zonisamide Viatris [Zonisamide Mylan]

Active substance (s)

Zonizamidas

Strength

50 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	50 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
65680	80189	1080189	lizdinė plokštelė	N14		Receptinis	EU/1/16/1093/005	Netiekiama	-	-	No	-	-
65681	80190	1080190	lizdinė plokštelė	N28		Receptinis	EU/1/16/1093/006	Netiekiama	-	-	No	-	-
65682	80191	1080191	lizdinė plokštelė	N56		Receptinis	EU/1/16/1093/007	Netiekiama	-	-	No	-	-
65683	80192	1080192	dalomoji lizdinė plokštelė	N14x1		Receptinis	EU/1/16/1093/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-31	Registruotas