Relvar Ellipta
fluticasone furoate / vilanterol
Table of contents
Overview
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.
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List item
Relvar Ellipta : EPAR - Medicine overview (PDF/76.82 KB)
First published: 10/12/2013
Last updated: 25/04/2018
EMA/731724/2013 -
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List item
Relvar Ellipta : EPAR - Risk-management-plan summary (PDF/233.76 KB)
First published: 07/06/2018
Last updated: 06/10/2022
Authorisation details
Product details | |
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Name |
Relvar Ellipta
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Agency product number |
EMEA/H/C/002673
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AK10
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Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline (Ireland) Limited
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Revision |
25
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Date of issue of marketing authorisation valid throughout the European Union |
13/11/2013
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Contact address |
12 Riverwalk |
Product information
06/07/2023 Relvar Ellipta - EMEA/H/C/002673 - WS2438/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic indication
Asthma indication:
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.
COPD indication:
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.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 201826/01/2018
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08/05/2015
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20/09/2013