Anoro Ellipta

Medicinal product

(Invented) name

Anoro Ellipta

Active substance (s)

Umeklidinas/Vilanterolas

Strength

55 µg/22 µg

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AL03, Vilanterol and umeclidinium bromide

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited, Airija

Date of authorisation

2014-05-08

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, pre-dispensed	1 dozėje
Umeklidinas	55 µg
Vilanterolas	22 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
59197	73421	1073421	inhaliatorius	7 dozės N1		Receptinis	EU/1/14/898/001	Netiekiama	-	-	No	-	-
59198	73422	1073422	inhaliatorius	30 dozių N1		Receptinis	EU/1/14/898/002	Tiekiama	-	-	No	-	-
59199	73423	1073423	inhaliatorius	90 dozių (N3x30) (sudėtinė)		Receptinis	EU/1/14/898/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-05-08	Registruotas