Zondaron

Medicinal product

(Invented) name

Zondaron

Active substance (s)

Ondansetronas

Strength

2 mg/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

SOPHARMA AD, Bulgarija

Date of authorisation

2014-10-16

Date of renewal

2019-10-01

Documents

3641_1_2_Pakuotės lapelis_200225.docx

3641_1_2_Zondaron_inj_inf_tirp_RPP_200225.docx

Ondansetron VVB_AR.pdf

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė 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
58042	72165	1072165	ampulė	4 ml N10		Receptinis	LT/1/14/3641/001	Netiekiama	-	-	No	-	-	Download
60423	74700	1074700	ampulė	4 ml N50		Receptinis	LT/1/14/3641/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-08-31	Išregistruotas
2019-10-01	Perregistruotas
2014-10-16	Registruotas