Azacitidine Accord

Medicinal product

(Invented) name

Azacitidine Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-02-13

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

Powder for solution for suspension	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
103353	89455	1089455	flakonas	100 mg N1		Receptinis	EU/1/19/1413/001	Netiekiama	2024-07-24	2025-12-31	Yes	2024-07-30	2025-12-31
108397	94501	1094501	flakonas	150 mg N1		Receptinis	EU/1/19/1413/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-02-13	Registruotas