Zofran

Medicinal product

(Invented) name

Zofran

Active substance (s)

Ondansetronas

Strength

8 mg

Pharmaceutical form

plėvele dengtos 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

Sandoz d.d., Slovėnija

Date of authorisation

1994-03-31

Date of renewal

2008-04-07

Documents

1091 Zofran 8mg pl dengtos tab II PL 2024 05 10.docx

1091 Pakuotės lapelis 2024 05 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ondansetronas	8 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
2209	2048	1002048	lizdinė plokštelė	N10		Receptinis	LT/1/94/1091/004	Netiekiama	-	-	No	-	-	Download
29554	32046	1032046	lizdinė plokštelė	N30		Receptinis	LT/1/94/1091/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-04-07	Perregistruotas
1994-03-31	Registruotas