Temybric Ellipta

Medicinal product

(Invented) name

Temybric Ellipta

Active substance (s)

Flutikazono furoatas/Umeklidinas/Vilanterolas

Strength

92 µg/55 µg/22 µg

Pharmaceutical form

dozuoti įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

R03AL08, Vilanterol, umeclidinium bromide and fluticasone furoate

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited, Airija

Date of authorisation

2019-06-12

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder, pre-dispensed	1 dozėje
Flutikazono furoatas	92 µg
Umeklidinas	55 µg
Vilanterolas	22 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
101933	88035	1088035	inhaliatorius	14 dozių N1	Receptinis	EU/1/19/1378/001	Netiekiama	-	-	No	-	-
101934	88036	1088036	inhaliatorius	30 dozių N1	Receptinis	EU/1/19/1378/002	Netiekiama	-	-	No	-	-
101935	88037	1088037	inhaliatorius	30 dozių N3 (90 dozių)	Receptinis	EU/1/19/1378/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-19	Išregistruotas
2019-06-12	Registruotas