Irinotecan Seacross

Medicinal product

(Invented) name

Irinotecan Seacross

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

Seacross Pharmaceuticals Limited, Jungtinė Karalystė

Date of authorisation

2011-04-21

Date of renewal

Documents

2422_1_4 Irinotecan Seacross konc II PL 170622.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

UK/H/4178/001/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
39264	52947	1052947	flakonas	2 ml N1		Receptinis	LT/1/11/2422/001	Netiekiama	-	-	No	-	-	Download
39265	52948	1052948	flakonas	5 ml N1		Receptinis	LT/1/11/2422/002	Netiekiama	-	-	No	-	-
39266	52949	1052949	flakonas	15 ml N1		Receptinis	LT/1/11/2422/003	Netiekiama	-	-	No	-	-
39267	52950	1052950	flakonas	25 ml N1		Receptinis	LT/1/11/2422/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-19	Išregistruotas
2011-04-21	Registruotas