Rolufta Ellipta

Medicinal product

(Invented) name

Rolufta 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

2017-03-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10c

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
67922	82483	1082483	inhaliatorius	7 dozės N1		Receptinis	EU/1/17/1174/001	Netiekiama	-	-	No	-	-
67923	82484	1082484	inhaliatorius	30 dozių N1		Receptinis	EU/1/17/1174/002	Netiekiama	-	-	No	-	-
67924	82485	1082485	inhaliatorius	N3x30 dozių (sudėtinė)		Receptinis	EU/1/17/1174/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-20	Registruotas