Decitabine Accord

Medicinal product

(Invented) name

Decitabine Accord

Active substance (s)

Decitabinas

Strength

50 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC08, Decitabine

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2026-05-04

Date of renewal

Documents

6012-13_pakuotes lapelis_2026-05-04.docx

6012-6013_Decitabine-Accord.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/1497/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Decitabinas	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
120696	106803	1106803	flakonas	N1		Receptinis	LT/1/26/6013/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-05-04	Registruotas