Hirobriz Breezhaler

Medicinal product

(Invented) name

Hirobriz 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
38942	52624	1052624	lizdinė plokštelė	N10 ir inhaliatorius		Receptinis	EU/1/09/594/001	Netiekiama	-	-	No	-	-
38943	52625	1052625	lizdinė plokštelė	N30 ir inhaliatorius		Receptinis	EU/1/09/594/002	Netiekiama	-	-	No	-	-
38944	52626	1052626	lizdinė plokštelė	N2x30 ir inhaliatorius		Receptinis	EU/1/09/594/003	Netiekiama	-	-	No	-	-
38945	52627	1052627	lizdinė plokštelė	N3x30 ir inhaliatorius		Receptinis	EU/1/09/594/004	Netiekiama	-	-	No	-	-
38946	52628	1052628	lizdinė plokštelė	N30x10 ir inhaliatorius		Receptinis	EU/1/09/594/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-30	Registruotas