Ondansetron Accord

Medicinal product

(Invented) name

Ondansetron Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2013-06-27

Date of renewal

2018-05-08

Documents

3331 Pakuotės lapelis 2025 03 24.docx

3331 Ondansetron Accord II PL 2025 03 24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4569/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Viename tirpalo mililitre 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
54707	68706	1068706	ampulė	2 ml N5		Receptinis	LT/1/13/3331/001	Netiekiama	2024-12-04	-	No	-	-
56495	70595	1070595	ampulė	2 ml N10		Receptinis	LT/1/13/3331/002	Netiekiama	-	-	No	-	-
56496	70596	1070596	ampulė	4 ml N5		Receptinis	LT/1/13/3331/003	Netiekiama	-	-	No	-	-
56497	70597	1070597	ampulė	4 ml N10		Receptinis	LT/1/13/3331/004	Netiekiama	2025-07-18	2025-12-31	Yes	2025-07-21	2025-12-31

Stadijos

Data	Stadija
2018-05-08	Perregistruotas
2013-06-27	Registruotas