Irinotecan Mylan [Irinotecan Strides]

Medicinal product

(Invented) name

Irinotecan Mylan [Irinotecan Strides]

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

Mylan S.A.S., Prancūzija

Date of authorisation

2012-04-27

Date of renewal

Documents

2918_1_2 Irinotecan Mylan konc RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2009/001/DC

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
41461	55219	1055219	buteliukas	2 ml N1		Receptinis	LT/1/12/2918/001	Netiekiama	-	-	No	-	-
41462	55220	1055220	buteliukas	5 ml N1		Receptinis	LT/1/12/2918/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-06-06	Išregistruotas
2012-04-27	Registruotas