Hirobriz Breezhaler

Medicinal product

(Invented) name

Hirobriz 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
38947	52629	1052629	lizdinė plokštelė	N10 ir inhaliatorius		Receptinis	EU/1/09/594/006	Netiekiama	-	-	No	-	-
38948	52630	1052630	lizdinė plokštelė	N30 ir inhaliatorius		Receptinis	EU/1/09/594/007	Netiekiama	-	-	No	-	-
38949	52631	1052631	lizdinė plokštelė	N2x30 ir inhaliatorius		Receptinis	EU/1/09/594/008	Netiekiama	-	-	No	-	-
38950	52632	1052632	lizdinė plokštelė	N3x30 ir inhaliatorius		Receptinis	EU/1/09/594/009	Netiekiama	-	-	No	-	-
38951	52633	1052633	lizdinė plokštelė	N30x10 ir inhaliatorius		Receptinis	EU/1/09/594/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-30	Registruotas