Irinotecan Fresenius

Medicinal product

(Invented) name

Irinotecan Fresenius

Active substance (s)

Irinotekano hidrochloridas trihidratas

Strength

20 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XX19, Irinotecan

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2009-04-10

Date of renewal

2018-05-29

Documents

1525_1_4 Pakuotės lapelis 190115.docx

1525_1_4 Irinotecan Fresenius konc inf RPP 190115.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0892/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Irinotekano hidrochloridas trihidratas	20 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
22375	25155	1025155	flakonas	2 ml N1		Receptinis	LT/1/09/1525/001	Netiekiama	-	-	No	-	-
23292	26014	1026014	flakonas	5 ml N1		Receptinis	LT/1/09/1525/002	Netiekiama	-	-	No	-	-
47595	61416	1061416	flakonas	25 ml N1		Receptinis	LT/1/09/1525/003	Netiekiama	-	-	No	-	-
55139	69172	1069172	flakonas	15 ml N1		Receptinis	LT/1/09/1525/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-31	Išregistruotas
2018-05-29	Perregistruotas
2009-04-10	Registruotas