Palonosetron Teva

Medicinal product

(Invented) name

Palonosetron Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2016-07-22

Date of renewal

Documents

3941_1 Palonosetron_Teva_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/4400/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 5 ml tirpalo flakone yra	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
61700	76042	1076042	flakonas	5 ml N1		Receptinis	LT/1/16/3941/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-06	Išregistruotas
2016-07-22	Registruotas