Setronon

Medicinal product

(Invented) name

Setronon

Active substance (s)

Ondansetronas

Strength

2 mg/ml

Pharmaceutical form

injekcinis 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

Teva Pharma B.V., Nyderlandai

Date of authorisation

2005-10-26

Date of renewal

2009-04-10

Documents

0192_5_8 Setronon inj RPP 170307.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0131/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ondansetronas	2 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
15175	19365	1019365	ampulė	2 ml N5		Receptinis	LT/1/05/0192/005	Netiekiama	-	-	No	-	-
17833	5445	1005445	ampulė	4 ml N5		Receptinis	LT/1/05/0192/006	Netiekiama	-	-	No	-	-	Download
23390	26093	1026093	ampulė	2 ml N1		Receptinis	LT/1/05/0192/007	Netiekiama	-	-	No	-	-
23391	26094	1026094	ampulė	4 ml N1		Receptinis	LT/1/05/0192/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-05	Išregistruotas
2009-04-10	Perregistruotas
2005-10-26	Registruotas