AZAVIN

Medicinal product

(Invented) name

AZAVIN

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

2024-07-05

Date of renewal

Documents

5488 AZAVIN RPP 2025 08 14.docx

5488 Pakuotės lapelis 2025 08 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/2296/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Spūsnyje (0,14 g) 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
114158	100270	1100270	buteliukas	120 spūsnių N1 (23 g, su purškalo pompa)		Receptinis	LT/1/24/5488/001	Netiekiama	-	-	No	-	-
118461	104567	1104567	buteliukas	120 spūsnių N3 (23 g, su purškalo pompa)		Receptinis	LT/1/24/5488/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-05	Registruotas