Riltrava Aerosphere

Medicinal product

(Invented) name

Riltrava Aerosphere

Active substance (s)

Formoterolio fumaratas dihidratas/Glikopironis/Budezonidas

Strength

5 µg/7,2 µg/160 µg

Pharmaceutical form

suslėgtoji įkvepiamoji suspensija

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

R03AL11, formoterol, glycopyrronium bromide and budesonide

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2022-01-06

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Each single actuation (delivered dose, ex-actuator) contains	1 išpurškime
Formoterolio fumaratas dihidratas	5 µg
Glikopironis	7,2 µg
Budezonidas	160 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
107845	93950	1093950	inhaliatorius	120 išpurškimų N1		Receptinis	EU/1/21/1604/001	Netiekiama	-	-	No	-	-
107846	93951	1093951	inhaliatorius	120 išpurškimų N3 (3×120)		Receptinis	EU/1/21/1604/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-06	Registruotas