Trelegy Ellipta


fluticasone furoate / umeclidinium / vilanterol

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Trelegy Ellipta. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide detailed practical advice on how to use Trelegy Ellipta.

For practical information about using Trelegy Ellipta, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/06/2018

Authorisation details

Product details
Trelegy Ellipta
Agency product number
Active substance
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
International non-proprietary name (INN) or common name
fluticasone furoate / umeclidinium / vilanterol
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
GlaxoSmithKline Trading Services
Date of issue of marketing authorisation valid throughout the European Union
Contact address
County Cork

Product information

29/05/2018 Trelegy Ellipta - EMEA/H/C/004363 - IG/0931


Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.

Assessment history

How useful was this page?

Add your rating