Azacitidine Kabi

Medicinal product

(Invented) name

Azacitidine Kabi

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

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2024-01-05

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

After reconstitution, each mL of suspension contains	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
112511	98631	1098631	flakonas	N1		Receptinis	EU/1/23/1777/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-05	Registruotas