Ondansetron Kabi

Medicinal product

(Invented) name

Ondansetron Kabi

Active substance (s)

Ondansetronas

Strength

0,16 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A04AA01, Ondansetron

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2023-04-18

Date of renewal

Documents

5166_5167 Pakuotės lapelis 2024 01 03.docx

5166_5167 Ondansetron Kabi PCS PL 2024 01 03.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/0640/003/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml infuzinio tirpalo yra:	1 ml
Ondansetronas	0,16 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
110861	96972	1096972	buteliukas	50 ml N1		Receptinis	LT/1/23/5167/001	Netiekiama	-	-	No	-	-
110862	96973	1096973	buteliukas	50 ml N10		Receptinis	LT/1/23/5167/002	Netiekiama	-	-	No	-	-
110863	96974	1096974	buteliukas	50 ml N20		Receptinis	LT/1/23/5167/003	Netiekiama	-	-	No	-	-
110864	96975	1096975	buteliukas	50 ml N40		Receptinis	LT/1/23/5167/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-18	Registruotas