Azacitidine Auxilia

Medicinal product

(Invented) name

Azacitidine Auxilia

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

Auxilia Pharma OÜ, Estija

Date of authorisation

2021-10-01

Date of renewal

Documents

4814 Azacitidine Auxilia PCS PL 2023 12 02.docx

4814 Pakuotės lapelis 2023 12 02.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/6310/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml paruoštos suspensijos yra:	1 ml
Azacitidinas	25 mg/ml

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
107277	93381	1093381	flakonas	100 mg N1		Receptinis	LT/1/21/4814/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-10-01	Registruotas