Palonosetron Sandoz

Medicinal product

(Invented) name

Palonosetron Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2017-02-13

Date of renewal

Documents

4046_1_6 Palonosetron Sandoz PCS PL 170825.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/4431/001/E/001

Marketing authorisation procedure

Kartotinė 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
67726	82282	1082282	flakonas	5 ml N1		Receptinis	LT/1/17/4046/001	Netiekiama	-	-	No	-	-	Download
67727	82283	1082283	flakonas	5 ml N2		Receptinis	LT/1/17/4046/002	Netiekiama	-	-	No	-	-
67728	82284	1082284	flakonas	5 ml N3		Receptinis	LT/1/17/4046/003	Netiekiama	-	-	No	-	-
67729	82285	1082285	flakonas	5 ml N5		Receptinis	LT/1/17/4046/004	Netiekiama	-	-	No	-	-
67730	82286	1082286	flakonas	5 ml N1	ASPĮ	Receptinis	LT/1/17/4046/005	Netiekiama	-	-	No	-	-
67731	82287	1082287	flakonas	5 ml N5	ASPĮ	Receptinis	LT/1/17/4046/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-03-31	Išregistruotas
2017-02-13	Registruotas