Cytarabine Accord

Medicinal product

(Invented) name

Cytarabine Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2010-08-13

Date of renewal

2018-05-08

Documents

2138 Pakuotės lapelis 2022 12 04.docx

2138 Cytarabine Accord II PL 2022 12 04.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4561/001/DC

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
31740	34155	1034155	flakonas	1 ml N1		Receptinis	LT/1/10/2138/001	Netiekiama	-	-	No	-	-
31741	34156	1034156	flakonas	1 ml N5		Receptinis	LT/1/10/2138/002	Netiekiama	-	-	No	-	-
31742	34157	1034157	flakonas	5 ml N1		Receptinis	LT/1/10/2138/003	Netiekiama	-	-	No	-	-
42432	56199	1056199	flakonas	5 ml N5		Receptinis	LT/1/10/2138/004	Netiekiama	-	-	No	-	-
42433	56200	1056200	flakonas	10 ml N1		Receptinis	LT/1/10/2138/005	Netiekiama	2025-06-25	-	No	-	-
52801	66735	1066735	flakonas	20 ml N1		Receptinis	LT/1/10/2138/006	Netiekiama	-	-	No	-	-
59931	74201	1074201	flakonas	40 ml N1		Receptinis	LT/1/10/2138/007	Netiekiama	-	-	No	-	-
59932	74202	1074202	flakonas	50 ml N1		Receptinis	LT/1/10/2138/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-08	Perregistruotas
2010-08-13	Registruotas