Trixeo Aerosphere

Medicinal product

(Invented) name

Trixeo Aerosphere

Active substance (s)

Formoterolio fumaratas dihidratas/Glikopironis/Budezonidas

Strength

5 µg/14,4 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

2020-12-09

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Spūsnyje (iš prietaiso išpurškiamoje dozėje) yra	1 spūsnis
Formoterolio fumaratas dihidratas	5 µg
Glikopironis	14,4 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
122361	108473	1108473	inhaliatorius	120 spūsnių N1		Receptinis	EU/1/20/1498/004	Netiekiama	-	-	No	-	-
122362	108474	1108474	inhaliatorius	120 spūsnių N3 (360 spūsnių)		Receptinis	EU/1/20/1498/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-09	Registruotas