Bevespi Aerosphere

Medicinal product

(Invented) name

Bevespi Aerosphere

Active substance (s)

Glikopironis/Formoterolio fumaratas dihidratas

Strength

7,2 µg/5 µg

Pharmaceutical form

suslėgtoji įkvepiamoji suspensija

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AL07, Formoterol and glycopyrronium bromide

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2018-12-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Pressurised inhalation, suspension	1 dozėje
Glikopironis	7,2 µg
Formoterolio fumaratas dihidratas	5 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
100766	86876	1086876	inhaliatorius	120 išpurškimų N1		Receptinis	EU/1/18/1339/001	Netiekiama	-	-	No	-	-
102571	88672	1088672	inhaliatorius	120 išpurškimų N3 (360 išpurškimų)		Receptinis	EU/1/18/1339/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-12-18	Registruotas