Revinty Ellipta

RSS

fluticasone furoate / vilanterol

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

Overview

An overview of Revinty Ellipta and why it is authorised in the EU

Revinty Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD). In asthma, it is used for regular treatment of patients from 12 years of age:

  • whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting beta-2 agonist;
  • whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting beta-2 agonist.

In COPD, it is used in adults who have flare-ups of the disease despite regular bronchodilator treatment (treatment to widen the airways).

Revinty Ellipta contains the active substances fluticasone furoate and vilanterol.

This medicine is the same as Relvar Ellipta, which is already authorised in the EU. The company that makes Relvar Ellipta has agreed that its scientific data can be used for Revinty Ellipta (‘informed consent’).

This EPAR was last updated on 18/09/2018

Authorisation details

Product details
Name
Revinty Ellipta
Agency product number
EMEA/H/C/002745
Active substance
  • fluticasone furoate
  • vilanterol trifenatate
International non-proprietary name (INN) or common name
fluticasone furoate / vilanterol
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03AK10
Publication details
Marketing-authorisation holder
Glaxo Group Ltd
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
02/05/2014
Contact address
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Product information

21/08/2018 Revinty Ellipta - EMEA/H/C/002745 - N/0037

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

Adrenergics and other drugs for obstructive airway diseases

Therapeutic indication

Asthma Indication
Revinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:

  • patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists.

COPD Indication
Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.

Assessment history

Changes since initial authorisation of medicine

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