Zonisamide Sandoz

Medicinal product

(Invented) name

Zonisamide Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2016-04-06

Date of renewal

2021-06-29

Documents

3903 Zonisamide Sandoz PCS PL 2023 05 23.docx

3903 Pakuotės lapelis 2023 05 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/6328/001

Marketing authorisation procedure

Decentralizuota procedūra

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
61530	75870	1075870	lizdinė plokštelė	N14		Receptinis	LT/1/16/3903/001	Netiekiama	-	-	No	-	-
65465	79969	1079969	lizdinė plokštelė	N28		Receptinis	LT/1/16/3903/002	Tiekiama	-	-	No	-	-	Download
65466	79970	1079970	lizdinė plokštelė	N56		Receptinis	LT/1/16/3903/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-29	Perregistruotas
2016-04-06	Registruotas