Trixeo Aerosphere

Medicinal product

(Invented) name

Trixeo 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

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

Pressurised inhalation, suspension	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
105430	91530	1091530	inhaliatorius	120 išpurškimų N1		Receptinis	EU/1/20/1498/002	Tiekiama	-	-	No	-	-
105431	91531	1091531	inhaliatorius	120 išpurškimų N3		Receptinis	EU/1/20/1498/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-09	Registruotas