Azelastine/Fluticasone Zentiva

Medicinal product

(Invented) name

Azelastine/Fluticasone Zentiva

Active substance (s)

Azelastino hidrochloridas/Flutikazono propionatas

Strength

137 µg/50 µg/spūsnyje

Pharmaceutical form

nosies purškalas (suspensija)

Route (s) of administration

vartoti į nosį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R01AD58, Fluticasone, combinations

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2026-08-11

Date of renewal

Documents

6112_pakuotes lapelis_2026-08-11.docx

6112_Azelast_Flutic_Zentiva.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

FI/H/1388/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Spūsnyje (0,14 g suspensijos) yra	1 spūsnis
Azelastino hidrochloridas	137 µg
Flutikazono propionatas	50 µg

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
121856	107964	1107964	buteliukas	120 spūsnių (23 g) N1		Receptinis	LT/1/26/6112/001	Netiekiama	-	-	No	-	-
121857	107965	1107965	buteliukas	120 spūsnių (23 g), N3		Receptinis	LT/1/26/6112/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-08-11	Registruotas