Zonisamide Sandoz

Medicinal product

(Invented) name

Zonisamide Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2016-04-06

Date of renewal

2021-06-29

Documents

3903 Pakuotės lapelis 2023 05 23.docx

3903 Zonisamide Sandoz PCS PL 2023 05 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/6328/002

Marketing authorisation procedure

Decentralizuota procedūra

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
61531	75871	1075871	lizdinė plokštelė	N14		Receptinis	LT/1/16/3903/004	Netiekiama	-	-	No	-	-
65467	79971	1079971	lizdinė plokštelė	N28		Receptinis	LT/1/16/3903/005	Tiekiama	-	-	No	-	-	Download
65468	79972	1079972	lizdinė plokštelė	N56		Receptinis	LT/1/16/3903/006	Netiekiama	-	-	No	-	-

Stadijos

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