Incruse Ellipta

Medicinal product

(Invented) name

Incruse Ellipta

Active substance (s)

Umeklidinas

Strength

55 µg

Pharmaceutical form

dozuoti įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03BB07, Umeclidinium bromide

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited, Airija

Date of authorisation

2014-04-28

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

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
59055	73276	1073276	inhaliatorius	7 dozės N1		Receptinis	EU/1/14/922/001	Netiekiama	-	-	No	-	-
59056	73277	1073277	inhaliatorius	30 dozių N1		Receptinis	EU/1/14/922/002	Tiekiama	2025-06-20	-	No	-	-
59057	73278	1073278	inhaliatorius	30 dozių N3 (90 dozių)		Receptinis	EU/1/14/922/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-04-28	Registruotas