Topotecan Kabi

Medicinal product

(Invented) name

Topotecan Kabi

Active substance (s)

Topotekanas

Strength

1 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)

L01XX17, Topotecan

Marketing authorisation holder

Fresenius Kabi Oncology Plc, Jungtinė Karalystė

Date of authorisation

2013-10-09

Date of renewal

Documents

2388_03-08 Topotecan_Kabi_DP.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

UK/H/2113/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename koncentrato mililitre yra	1 ml
Topotekanas	1 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
52949	66889	1066889	flakonas	1 ml N1		Receptinis	LT/1/11/2388/003	Netiekiama	-	-	No	-	-
57400	71515	1071515	flakonas	1 ml N5		Receptinis	LT/1/11/2388/004	Netiekiama	-	-	No	-	-
57401	71516	1071516	flakonas	4 ml N1		Receptinis	LT/1/11/2388/005	Netiekiama	-	-	No	-	-
57402	71517	1071517	flakonas	4 ml N5		Receptinis	LT/1/11/2388/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-04	Išregistruotas
2013-10-09	Registruotas