Cytarabine Kabi

Medicinal product

(Invented) name

Cytarabine Kabi

Active substance (s)

Citarabinas

Strength

100 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC01, Cytarabine

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2012-07-19

Date of renewal

2022-06-09

Documents

3015 Cytarabine Kabi_perr2022-06-09.docx

3015 pakuotes lapelis_2022-06-09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2328/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Citarabinas	100 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
44504	58299	1058299	flakonas	1 ml N1		Receptinis	LT/1/12/3015/001	Netiekiama	-	-	No	-	-
52966	66906	1066906	flakonas	5 ml N1		Receptinis	LT/1/12/3015/002	Netiekiama	-	-	No	-	-	Download
52967	66907	1066907	flakonas	10 ml N1		Receptinis	LT/1/12/3015/003	Tiekiama	-	-	No	-	-	Download
52968	66908	1066908	flakonas	20 ml N1		Receptinis	LT/1/12/3015/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-09	Perregistruotas
2012-07-19	Registruotas