Ondansetron Baxter

Medicinal product

(Invented) name

Ondansetron Baxter

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

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2009-11-25

Date of renewal

2022-01-28

Documents

1782 Ondansetron Baxter PCS PL 2022 02 23.docx

1782 Pakuotės lapelis 2022 02 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0865/001

Marketing authorisation procedure

Decentralizuota 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
23862	5467	1005467	ampulė	2 ml N5		Receptinis	LT/1/09/1782/001	Tiekiama	-	-	No	-	-	Download
26858	29423	1029423	ampulė	2 ml N25		Receptinis	LT/1/09/1782/002	Netiekiama	-	-	No	-	-
39379	5584	1005584	ampulė	4 ml N5		Receptinis	LT/1/09/1782/003	Netiekiama	2025-01-01	2025-10-01	No	-	-
39380	53079	1053079	ampulė	4 ml N25		Receptinis	LT/1/09/1782/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-28	Perregistruotas
2009-11-25	Registruotas