Bemrist Breezhaler

Medicinal product

(Invented) name

Bemrist Breezhaler

Active substance (s)

Indakaterolis/Mometazono furoatas

Strength

125 µg/127,5 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	127,5 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
104250	90354	1090354	dalomoji lizdinė plokštelė	N10x1 ir inhaliatorius		Receptinis	EU/1/20/1441/005	Netiekiama	-	-	No	-	-
104251	90355	1090355	dalomoji lizdinė plokštelė	N30x1 ir inhaliatorius		Receptinis	EU/1/20/1441/006	Netiekiama	-	-	No	-	-
104252	90356	1090356	dalomoji lizdinė plokštelė	N90x1 (3x30x1) ir 3 inhaliatoriai		Receptinis	EU/1/20/1441/007	Netiekiama	-	-	No	-	-
104253	90357	1090357	dalomoji lizdinė plokštelė	N150x1 (15x10x1) ir 15 inhaliatorių		Receptinis	EU/1/20/1441/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-30	Registruotas