Palonosetron Accord

Medicinal product

(Invented) name

Palonosetron Accord

Active substance (s)

Palonosetronas

Strength

250 µg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A04AA05, Palonosetron

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2016-05-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	5 ml
Palonosetronas	250 µg

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
66038	80554	1080554	flakonas	5 ml N1		Receptinis	EU/1/16/1104/001	Tiekiama	2025-08-02	-	No	-	-

Stadijos

Data	Stadija
2016-05-26	Registruotas