Irinotecan Kabi

Medicinal product

(Invented) name

Irinotecan Kabi

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)

L01CE02, Irinotecan

Marketing authorisation holder

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

Date of authorisation

2009-07-21

Date of renewal

2017-07-27

Documents

1640 Irinotecan Kabi konc PCS 2024 12 19.docx

1640 Pakuotės lapelis 2024 04 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0742/001

Marketing authorisation procedure

Savitarpio pripažinimo 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
23239	25962	1025962	flakonas	2 ml N1		Receptinis	LT/1/09/1640/001	Netiekiama	-	-	No	-	-	Download
23240	25963	1025963	flakonas	5 ml N1		Receptinis	LT/1/09/1640/002	Tiekiama	-	-	No	-	-	Download
40397	54134	1054134	flakonas	15 ml N1		Receptinis	LT/1/09/1640/003	Netiekiama	-	-	No	-	-
40398	54135	1054135	flakonas	25 ml N1		Receptinis	LT/1/09/1640/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2017-07-27	Perregistruotas
2009-07-21	Registruotas