Azelastine/Fluticasone Teva [Azelastine hydrochloride/Fluticasone propionate Teva]

Medicinal product

(Invented) name

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)

ATC code (s)

R01AD58, Fluticasone, combinations

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2023-11-06

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/7110/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename 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
111882	97997	1097997	buteliukas	120 spūsnių (23 g) N1		Receptinis	LT/1/23/5254/001	Tiekiama	2025-08-27	-	No	-	-
111883	97998	1097998	buteliukas	120 spūsnių (23 g) N3		Receptinis	LT/1/23/5254/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-06	Registruotas