fluticasone furoate / vilanterol
Relvar 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).
Relvar Ellipta contains the active substances fluticasone furoate and vilanterol.
Relvar Ellipta : EPAR - Medicine overview (PDF/76.82 KB)
First published: 10/12/2013
Last updated: 25/04/2018
Relvar Ellipta : EPAR - Risk-management-plan summary (PDF/682.36 KB)
First published: 07/06/2018
Last updated: 20/08/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Pulmonary Disease, Chronic Obstructive
|Anatomical therapeutic chemical (ATC) code||
GlaxoSmithKline (Ireland) Limited
|Date of issue of marketing authorisation valid throughout the European Union||
24/04/2019 Relvar Ellipta - EMEA/H/C/002673 - N/0044
- 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
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Relvar 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.
- patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.
Relvar 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.