Onbrez Breezhaler

Medicinal product

(Invented) name

Onbrez Breezhaler

Active substance (s)

Indakaterolis

Strength

150 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	150 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
38718	52400	1052400	lizdinė plokštelė	N10 ir inhaliatorius		Receptinis	EU/1/09/593/001	Netiekiama	-	-	No	-	-
38719	52401	1052401	lizdinė plokštelė	N30 ir inhaliatorius		Receptinis	EU/1/09/593/002	Tiekiama	-	-	No	-	-
38720	52402	1052402	lizdinė plokštelė	N2x30 ir inhaliatorius		Receptinis	EU/1/09/593/003	Netiekiama	-	-	No	-	-
38721	52403	1052403	lizdinė plokštelė	N3x30 ir inhaliatorius		Receptinis	EU/1/09/593/004	Netiekiama	-	-	No	-	-
38722	52404	1052404	lizdinė plokštelė	N30x10 ir inhaliatorius		Receptinis	EU/1/09/593/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-30	Registruotas