Azacitidine Mylan

Medicinal product

(Invented) name

Azacitidine Mylan

Active substance (s)

Azacitidinas

Strength

25 ml/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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2020-03-27

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

Paruošus, kiekviename suspensijos ml yra	1 ml
Azacitidinas	25 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
103708	89810	1089810	flakonas	N1		Receptinis	EU/1/20/1426/001	Netiekiama	2024-09-30	-	No	-	-
103709	89811	1089811	flakonas	N7		Receptinis	EU/1/20/1426/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-03-27	Registruotas