Dymista

Medicinal product

(Invented) name

Dymista

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

3227 Dymista PCS II PL 2024 08 29.docx

3227 Pakuotės lapelis 2024 08 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DE/H/3355/001/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
49124	62990	1062990	buteliukas	28 dozės N1		Receptinis	LT/1/13/3227/001	Netiekiama	-	-	No	-	-
55340	69388	1069388	buteliukas	28 dozės N10		Receptinis	LT/1/13/3227/002	Netiekiama	-	-	No	-	-
55341	69389	1069389	buteliukas	120 dozių N1		Receptinis	LT/1/13/3227/003	Tiekiama	-	-	No	-	-	Download
55342	69390	1069390	buteliukas	120 dozių N3		Receptinis	LT/1/13/3227/004	Netiekiama	-	-	No	-	-

Stadijos

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