Fludarabine Kabi

Medicinal product

(Invented) name

Fludarabine Kabi

Active substance (s)

Fludarabinas

Strength

50 mg

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BB05, Fludarabine

Marketing authorisation holder

Fresenius Kabi Oncology Plc, Jungtinė Karalystė

Date of authorisation

2013-03-27

Date of renewal

Documents

3257_01 Fludarabine_Kabi_DP.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Fludarabinas	50 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
49857	63728	1063728	flakonas	N1		Receptinis	LT/1/13/3257/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-04-06	Išregistruotas
2013-03-27	Registruotas