Irinotecan Accord

Medicinal product

(Invented) name

Irinotecan Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2016-08-08

Date of renewal

2021-08-27

Documents

3953 Pakuotės lapelis 2025 04 02.docx

3953 Irinotecan Accord II PL 2025 04 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4565/001

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
61772	76128	1076128	flakonas	2 ml N1		Receptinis	LT/1/16/3953/001	Netiekiama	-	-	No	-	-
66169	80691	1080691	flakonas	5 ml N1		Receptinis	LT/1/16/3953/002	Netiekiama	2024-10-22	2024-11-29	No	-	-
66170	80692	1080692	flakonas	15 ml N1		Receptinis	LT/1/16/3953/003	Netiekiama	-	-	No	-	-
66171	80693	1080693	flakonas	25 ml N1		Receptinis	LT/1/16/3953/004	Netiekiama	-	-	No	-	-
103802	89904	1089904	flakonas	50 ml N1		Receptinis	LT/1/16/3953/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-27	Perregistruotas
2016-08-08	Registruotas