Azecort

Medicinal product

(Invented) name

Azecort

Active substance (s)

Azelastino hidrochloridas/Flutikazono propionatas

Strength

137 µg/50 µg/dozėje

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

Viatris Healthcare Limited, Airija

Date of authorisation

2013-02-28

Date of renewal

2018-05-29

Documents

3225 Azecort PCS II PL 2024 08 29.docx

3225 Pakuotės lapelis 2024 08 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DE/H/3356/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vienoje dozėje (0,14 g) yra	1 dozėje
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
49125	62991	1062991	buteliukas	28 dozės N1		Receptinis	LT/1/13/3225/001	Netiekiama	-	-	No	-	-
55337	69385	1069385	buteliukas	28 dozės N10		Receptinis	LT/1/13/3225/002	Netiekiama	-	-	No	-	-
55338	69386	1069386	buteliukas	120 dozių N1		Receptinis	LT/1/13/3225/003	Netiekiama	-	-	No	-	-
55339	69387	1069387	buteliukas	120 dozių N3		Receptinis	LT/1/13/3225/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-29	Perregistruotas
2013-02-28	Registruotas