Dualesia

Medicinal product

(Invented) name

Dualesia

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

Adalvo Limited, Malta

Date of authorisation

2026-08-17

Date of renewal

Documents

6128_pakuotes lapelis_2026-08-17.docx

6128_Dualesia.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

FI/H/1414/001/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
122010	108117	1108117	buteliukas	120 spūsnių (23 g) N1		Receptinis	LT/1/26/6128/001	Netiekiama	-	-	No	-	-
122011	108118	1108118	buteliukas	120 spūsnių (23 g) N3		Receptinis	LT/1/26/6128/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-08-17	Registruotas