Onbrez Breezhaler

Medicinal product

(Invented) name

Onbrez Breezhaler

Active substance (s)

Indakaterolis

Strength

300 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)

R03AC18, Indacaterol

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2009-11-30

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder, hard capsule	1 vnt.
Indakaterolis	300 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
38723	52405	1052405	lizdinė plokštelė	N10 ir inhaliatorius		Receptinis	EU/1/09/593/006	Netiekiama	-	-	No	-	-
38724	52406	1052406	lizdinė plokštelė	N30 ir inhaliatorius		Receptinis	EU/1/09/593/007	Tiekiama	-	-	No	-	-
38725	52407	1052407	lizdinė plokštelė	N2x30 ir inhaliatorius		Receptinis	EU/1/09/593/008	Netiekiama	-	-	No	-	-
38726	52408	1052408	lizdinė plokštelė	N3x30 ir inhaliatorius		Receptinis	EU/1/09/593/009	Netiekiama	-	-	No	-	-
38727	52409	1052409	lizdinė plokštelė	N30x10 ir inhaliatorius		Receptinis	EU/1/09/593/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-30	Registruotas