Zofran Zydis

Medicinal product

(Invented) name

Zofran Zydis

Active substance (s)

Ondansetronas

Strength

4 mg

Pharmaceutical form

burnoje disperguojamos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A04AA01, Ondansetron

Marketing authorisation holder

SIA Novartis Baltics , Latvija

Date of authorisation

2003-05-20

Date of renewal

2013-03-12

Documents

3250 Pakuotės lapelis 2022 02 25.docx

3250 Zofran Zydis disperg tab II PL 2022 02 25.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Vienoje tabletėje yra	1 vnt.
Ondansetronas	4 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
8066	4095	1004095	dvisluoksnė juostelė	N10		Receptinis	LT/1/03/3250/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-31	Išregistruotas
2013-03-12	Perregistruotas
2003-05-20	Registruotas