Flixonase

Medicinal product

(Invented) name

Flixonase

Active substance (s)

Flutikazono propionatas

Strength

50 µg/išpurškime

Pharmaceutical form

nosies purškalas (suspensija)

Route (s) of administration

vartoti į nosį

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R01AD08, Fluticasone

Marketing authorisation holder

GlaxoSmithKline Dungarvan Limited, Airija

Date of authorisation

2015-10-12

Date of renewal

Documents

3806 Pakuotės lapelis Rp 2021 11 19.docx

3806 Flixonase Rp PCS PL 2021 11 19.docx

3806 Pakuotės lapelis OTC 2021 11 19.docx

3806 Flixonase OTC PCS PL 2021 11 19.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PT/H/2266/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename išpurškime (dozėje) yra	1 išpurškime
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
58818	73034	1073034	buteliukas	60 išpurškimų N1		Nereceptinis	LT/1/15/3806/001	Netiekiama	-	-	No	-	-
98639	84743	1084743	buteliukas	120 išpurškimų, N1		Receptinis	LT/1/15/3806/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-27	Išregistruotas
2015-10-12	Registruotas