Relvar Ellipta

Medicinal product

(Invented) name

Relvar Ellipta

Active substance (s)

Flutikazono furoatas/Vilanterolas

Strength

184 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	184 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
57985	72107	1072107	lizdinė plokštelė	14 dozių N1		Receptinis	EU/1/13/886/004	Netiekiama	-	-	No	-	-
57986	72108	1072108	lizdinė plokštelė	30 dozių N1		Receptinis	EU/1/13/886/005	Tiekiama	-	-	No	-	-
57987	72109	1072109	lizdinė plokštelė	90 dozių (N3x30)		Receptinis	EU/1/13/886/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-13	Registruotas