Relvar Ellipta

Medicinal product

(Invented) name

Relvar Ellipta

Active substance (s)

Flutikazono furoatas/Vilanterolas

Strength

92 µg/22 µg

Pharmaceutical form

dozuoti įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AK10, Vilanterol and fluticasone furoate

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited, Airija

Date of authorisation

2013-11-13

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
Flutikazono furoatas	92 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
57982	72104	1072104	lizdinė plokštelė	14 dozių N1		Receptinis	EU/1/13/886/001	Netiekiama	-	-	No	-	-
57983	72105	1072105	lizdinė plokštelė	30 dozių N1		Receptinis	EU/1/13/886/002	Tiekiama	-	-	No	-	-
57984	72106	1072106	lizdinė plokštelė	90 dozių (N3x30)		Receptinis	EU/1/13/886/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-13	Registruotas