Elebrato Ellipta

RSS

fluticasone furoate / umeclidinium / vilanterol

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Elebrato 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 Elebrato Ellipta.

For practical information about using Elebrato 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
Name
Elebrato Ellipta
Agency product number
EMEA/H/C/004781
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
R03AL08
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 Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
15/11/2017
Contact address
Currabinny
Carrigaline
County Cork
Ireland

Product information

30/05/2018 Elebrato Ellipta - EMEA/H/C/004781 - IG/0931

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

Not yet assigned

Therapeutic indication

Elebrato 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