Bemrist Breezhaler

Medicinal product

(Invented) name

Bemrist Breezhaler

Active substance (s)

Indakaterolis/Mometazono furoatas

Strength

125 µg/62,5 µg

Pharmaceutical form

įkvepiamieji milteliai (kietosios kapsulės)

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AK14, indacaterol and mometasone

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2020-05-30

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

Each delivered dose contains	1 dozėje
Indakaterolis	125 µg
Mometazono furoatas	62,5 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
104246	90350	1090350	dalomoji lizdinė plokštelė	N10x1 ir inhaliatorius		Receptinis	EU/1/20/1441/001	Netiekiama	-	-	No	-	-
104247	90351	1090351	dalomoji lizdinė plokštelė	N30x1 ir inhaliatorius		Receptinis	EU/1/20/1441/002	Netiekiama	-	-	No	-	-
104248	90352	1090352	dalomoji lizdinė plokštelė	N90x1 (3x30x1) ir 3 inhaliatoriai		Receptinis	EU/1/20/1441/003	Netiekiama	-	-	No	-	-
104249	90353	1090353	dalomoji lizdinė plokštelė	N150x1 (15x10x1) ir 15 inhaliatorių		Receptinis	EU/1/20/1441/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-30	Registruotas