Irinotecan Actavis

Medicinal product

(Invented) name

Irinotecan Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2008-01-17

Date of renewal

2010-03-31

Documents

0956 Irinotecan Actavis konc inf PCS PL 2021_06_01.docx

0956 Pakuotės lapelis 2021_06_01.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1728/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato 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
20691	23659	1023659	buteliukas	2 ml N1		Receptinis	LT/1/08/0956/001	Netiekiama	-	-	No	-	-	Download
20692	23660	1023660	buteliukas	5 ml N1		Receptinis	LT/1/08/0956/002	Netiekiama	-	-	No	-	-
38959	52641	1052641	buteliukas	25 ml N1		Receptinis	LT/1/08/0956/003	Netiekiama	-	-	No	-	-
38958	52640	1052640	buteliukas	5 ml N5		Receptinis	LT/1/08/0956/004	Netiekiama	-	-	No	-	-
44280	58073	1058073	buteliukas	15 ml N1		Receptinis	LT/1/08/0956/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-28	Išregistruotas
2010-03-31	Perregistruotas
2008-01-17	Registruotas