Zofran

Medicinal product

(Invented) name

Zofran

Active substance (s)

Ondansetronas

Strength

8 mg/4 ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

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

2004-03-31

Date of renewal

2008-04-07

Documents

1091 Zofran inj_inf II PL 2024 08 26.docx

1091 Pakuotės lapelis 2024 08 26.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

4 ml tirpalo yra	4 ml
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
18370	5448	1005448	ampulė	4 ml N5		Receptinis	LT/1/94/1091/008	Netiekiama	-	-	No	-	-	Download
29555	32047	1032047	užpildytas švirkštas	4 ml N5		Receptinis	LT/1/94/1091/009	Netiekiama	-	-	No	-	-
106061	92162	1092162	ampulė	4 ml N8		Receptinis	LT/1/94/1091/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-04-07	Perregistruotas
2004-03-31	Registruotas