FERANT

Medicinal product

(Invented) name

FERANT

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

Medochemie Ltd., Kipras

Date of authorisation

2016-07-22

Date of renewal

2021-03-05

Documents

3936 FERANT PCS 2024 12 12.docx

3936 Pakuotės lapelis 2021 11 04.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1541/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje (5 ml tirpalo) 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
61720	76063	1076063	ampulė	5 ml N1		Receptinis	LT/1/16/3936/001	Tiekiama	-	-	No	-	-	Download
66056	80576	1080576	ampulė	5 ml N5		Receptinis	LT/1/16/3936/002	Netiekiama	-	-	No	-	-
66057	80577	1080577	ampulė	5 ml N10		Receptinis	LT/1/16/3936/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-05	Perregistruotas
2016-07-22	Registruotas