Ondansetron Kabi

Medicinal product

(Invented) name

Ondansetron Kabi

Active substance (s)

Ondansetronas

Strength

0,08 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 Ondansetron Kabi PCS PL 2024 01 03.docx

5166_5167 Pakuotės lapelis 2024 01 03.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/0640/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml infuzinio tirpalo yra:	1 ml
Ondansetronas	0,08 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
110853	96964	1096964	buteliukas	50 ml N1		Receptinis	LT/1/23/5166/001	Netiekiama	-	-	No	-	-
110854	96965	1096965	buteliukas	50 ml N10		Receptinis	LT/1/23/5166/002	Netiekiama	-	-	No	-	-
110855	96966	1096966	buteliukas	50 ml N20		Receptinis	LT/1/23/5166/003	Netiekiama	-	-	No	-	-
110856	96967	1096967	buteliukas	50 ml N40		Receptinis	LT/1/23/5166/004	Netiekiama	-	-	No	-	-
110857	96968	1096968	buteliukas	100 ml N1		Receptinis	LT/1/23/5166/005	Netiekiama	-	-	No	-	-
110858	96969	1096969	buteliukas	100 ml N10		Receptinis	LT/1/23/5166/006	Netiekiama	-	-	No	-	-
110859	96970	1096970	buteliukas	100 ml N20		Receptinis	LT/1/23/5166/007	Netiekiama	-	-	No	-	-
110860	96971	1096971	buteliukas	100 ml N40		Receptinis	LT/1/23/5166/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-18	Registruotas