Azacitidine ICG farma

Medicinal product

(Invented) name

Azacitidine ICG farma

Active substance (s)

Azacitidinas

Strength

25 mg/ml

Pharmaceutical form

milteliai injekcinei suspensijai

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC07, Azacitidine

Marketing authorisation holder

UAB ICG farma, Lietuva

Date of authorisation

2023-07-26

Date of renewal

Documents

5208_pakuotes lapelis_2023-07-26.docx

LT_H_0174_1_DC_PAR+LT_apzvalga.pdf

5208_Azicitidine ICG farma.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0174/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml paruoštos suspensijos yra:	1 ml
Azacitidinas	25 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
111325	97438	1097438	flakonas	100 mg N1		Receptinis	LT/1/23/5208/001	Netiekiama	-	-	No	-	-
111326	97439	1097439	flakonas	150 mg N1		Receptinis	LT/1/23/5208/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-26	Registruotas