ONDAVELL

Medicinal product

(Invented) name

ONDAVELL

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

UAB "Eletis Medica", Lietuva

Date of authorisation

2012-03-27

Date of renewal

Documents

2864_01 ONDAVELL.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

4 ml tirpalo (vienoje ampulėje) 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
47541	61358	1061358	ampulė	4 ml N5		Receptinis	LT/1/12/2864/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-31	Išregistruotas
2012-03-27	Registruotas