Revinty Ellipta


fluticasone furoate / vilanterol

This medicine is authorised for use in the European Union.


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 21/05/2019

Authorisation details

Product details
Revinty Ellipta
Agency product number
Active substance
  • fluticasone furoate
  • vilanterol trifenatate
International non-proprietary name (INN) or common name
fluticasone furoate / vilanterol
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GlaxoSmithKline (Ireland) Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24

Product information

24/04/2019 Revinty Ellipta - EMEA/H/C/002745 - N/0042


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

How useful was this page?

Add your rating
1 rating