Relvar Ellipta

fluticasone furoate / vilanterol

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

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.

: Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms). The doctor will decide which inhaler the patient should use. The dose is one inhalation (‘puff’) into the mouth once a day at the same time each day.
Relvar Ellipta can only be obtained with a prescription. For more information about using Relvar Ellipta, see the package leaflet or contact your doctor or pharmacist.

: Relvar Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Fluticasone furoate is a corticosteroid. It works on various types of immune cells, blocking the release of substances involved in inflammation. This reduces inflammation in the airways and improves the patient’s breathing.
Vilanterol is a long-acting beta-2 agonist. It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.

: Asthma
Three studies in over 3,200 patients showed that Relvar Ellipta improves breathing and reduces flare-ups in patients with asthma.
In two of the studies, Relvar Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV₁) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment). Relvar Ellipta 184/22 also improved FEV₁by193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
In a third study, fewer patients taking Relvar Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
A fourth study in 1,522 patients showed that Relvar Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol). These patients were already well controlled with the comparator medicine and Relvar Ellipta treatment was able to maintain their FEV₁.
COPD
Four studies in over 5,500 patients showed that Relvar Ellipta improves breathing and reduces flare-ups of symptoms in patients with COPD.
The first study showed that Relvar Ellipta 92/22 improved average FEV₁ by 115 ml more than placebo, and a second study showed that Relvar Ellipta 184/22 improved average FEV₁ by 131 ml more than placebo.
In two further studies, Relvar Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.

: The most common side effects with Relvar Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat). More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma. For the full list of side effects of Relvar Ellipta, see the package leaflet.

: Relvar Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD. Regarding its safety, the most frequent side effects reported with Relvar Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
The European Medicines Agency concluded that Relvar Ellipta’s benefits are greater than its risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relvar Ellipta have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Relvar Ellipta are continuously monitored. Side effects reported with Relvar Ellipta are carefully evaluated and any necessary action taken to protect patients.

: Relvar Ellipta received a marketing authorisation valid throughout the EU on 13 November 2013.

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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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  (PDF/105.29 KB)
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  (PDF/74.82 KB)
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  (PDF/75 KB)
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  (PDF/84.32 KB)
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  (PDF/74.91 KB)
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  (PDF/76.3 KB)
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  (PDF/76.74 KB)
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  (PDF/111.32 KB)
- Hungarian
  (PDF/95.48 KB)
- Italian
  (PDF/74.85 KB)
- Latvian
  (PDF/106.53 KB)
- Lithuanian
  (PDF/100.11 KB)
- Maltese
  (PDF/101.45 KB)
- Polish
  (PDF/101.07 KB)
- Portuguese
  (PDF/75.85 KB)
- Romanian
  (PDF/107.22 KB)
- Slovak
  (PDF/99.53 KB)
- Slovenian
  (PDF/93.25 KB)
- Spanish
  (PDF/76.03 KB)
- Swedish
  (PDF/75.1 KB)
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Relvar Ellipta : EPAR - Risk-management-plan summary (PDF/233.76 KB)

First published: 07/06/2018
Last updated: 06/10/2022

This EPAR was last updated on 04/09/2023

Authorisation details

Product details
Name	Relvar Ellipta
Agency product number	EMEA/H/C/002673
Active substance	fluticasone furoate vilanterol
International non-proprietary name (INN) or common name	fluticasone furoate vilanterol
Therapeutic area (MeSH)	Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code	R03AK10

Publication details
Marketing-authorisation holder	GlaxoSmithKline (Ireland) Limited
Revision	25
Date of issue of marketing authorisation valid throughout the European Union	13/11/2013
Contact address	12 Riverwalk Citywest Business Campus Dublin 24 Ireland

Product information

06/07/2023 Relvar Ellipta - EMEA/H/C/002673 - WS2438/G

List item

Relvar Ellipta : EPAR - Product Information (PDF/1.04 MB) (updated)

First published: 10/12/2013
Last updated: 04/09/2023
- Bulgarian
  (PDF/1.26 MB)
- Croatian
  (PDF/1.36 MB)
- Czech
  (PDF/1.23 MB)
- Danish
  (PDF/1.24 MB)
- Dutch
  (PDF/1.06 MB)
- Estonian
  (PDF/1.15 MB)
- Finnish
  (PDF/1.14 MB)
- French
  (PDF/1.09 MB)
- German
  (PDF/1.48 MB)
- Greek
  (PDF/1.13 MB)
- Hungarian
  (PDF/1.33 MB)
- Icelandic
  (PDF/1.16 MB)
- Italian
  (PDF/1.27 MB)
- Latvian
  (PDF/1.49 MB)
- Lithuanian
  (PDF/1.33 MB)
- Maltese
  (PDF/1.05 MB)
- Norwegian
  (PDF/1.45 MB)
- Polish
  (PDF/1.18 MB)
- Portuguese
  (PDF/1.16 MB)
- Romanian
  (PDF/1.38 MB)
- Slovak
  (PDF/1.41 MB)
- Slovenian
  (PDF/1.83 MB)
- Spanish
  (PDF/1.13 MB)
- Swedish
  (PDF/1.33 MB)

Other EU languages available icon 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.

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Relvar Ellipta : EPAR - All Authorised presentations (PDF/22.79 KB)

First published: 10/12/2013
Last updated: 10/12/2013
- Bulgarian
  (PDF/42.78 KB)
- Croatian
  (PDF/29.72 KB)
- Czech
  (PDF/38.91 KB)
- Danish
  (PDF/20.59 KB)
- Dutch
  (PDF/20.37 KB)
- Estonian
  (PDF/23.01 KB)
- Finnish
  (PDF/23.76 KB)
- French
  (PDF/20.23 KB)
- German
  (PDF/22.94 KB)
- Greek
  (PDF/44.74 KB)
- Hungarian
  (PDF/27.12 KB)
- Icelandic
  (PDF/20.94 KB)
- Italian
  (PDF/23.66 KB)
- Latvian
  (PDF/42.54 KB)
- Lithuanian
  (PDF/38.05 KB)
- Maltese
  (PDF/39.43 KB)
- Norwegian
  (PDF/22.93 KB)
- Polish
  (PDF/39.07 KB)
- Portuguese
  (PDF/20.39 KB)
- Romanian
  (PDF/35.4 KB)
- Slovak
  (PDF/36.89 KB)
- Slovenian
  (PDF/25.7 KB)
- Spanish
  (PDF/21.29 KB)
- Swedish
  (PDF/22.21 KB)

Pharmacotherapeutic group

Adrenergics and other drugs for obstructive airway diseases

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

Changes since initial authorisation of medicine

List item

Relvar Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/260.46 KB) (updated)

First published: 13/08/2014
Last updated: 04/09/2023
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Relvar Ellipta-H-C-02673-P46-016 : EPAR - Assessment Report (PDF/2.67 MB)

Adopted

First published: 02/02/2023
EMA/30446/2023
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Relvar Ellipta-H-C-02673-P46-015 : EPAR - Assessment Report (PDF/1004.63 KB)

Adopted

First published: 18/03/2022
EMA/168280/2022
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Relvar Ellipta-H-C-2673-WS-0708 : EPAR - Assessment Report - Variation (PDF/706.83 KB)

Adopted

First published: 28/01/2020
EMA/499766/2015
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Relvar Ellipta-H-C-2673-WS-1208 : EPAR - Assessment Report - Variation (PDF/1.63 MB)

Adopted

First published: 25/04/2018
Last updated: 25/04/2018
EMA/CHMP/187802/2018
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Relvar Ellipta-H-C-2673-P46-0012 : EPAR - Assessment Report (PDF/1.03 MB)

Adopted

First published: 30/01/2018
Last updated: 30/01/2018
EMA/61047/2018
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Relvar Ellipta-H-C-2673-P46-0011 : EPAR - Assessment Report (PDF/2.13 MB)

Adopted

First published: 30/01/2018
Last updated: 30/01/2018
EMA/60086/2018
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CHMP post-authorisation summary of positive opinion for Relvar Ellipta (WS-1208) (PDF/73.71 KB)

Adopted

First published: 26/01/2018
Last updated: 26/01/2018
EMA/CHMP/12287/2018
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Relvar Ellipta-H-C-2673-A31-14165: EPAR - Assessment Report - Article 31 (PDF/228.27 KB)

Adopted

First published: 15/07/2016
Last updated: 15/07/2016
EMA/330021/2016
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Relvar Ellipta : EPAR - Scientific Conclusion (PDF/39.48 KB)

First published: 15/07/2016
Last updated: 15/07/2016
- Bulgarian
  (PDF/71.2 KB)
- Croatian
  (PDF/66.46 KB)
- Czech
  (PDF/71.36 KB)
- Danish
  (PDF/38.68 KB)
- Dutch
  (PDF/39.18 KB)
- Estonian
  (PDF/46.81 KB)
- Finnish
  (PDF/38.28 KB)
- French
  (PDF/39.98 KB)
- German
  (PDF/41.37 KB)
- Greek
  (PDF/74.71 KB)
- Hungarian
  (PDF/57.06 KB)
- Italian
  (PDF/38.8 KB)
- Latvian
  (PDF/66.17 KB)
- Lithuanian
  (PDF/68.75 KB)
- Maltese
  (PDF/71.25 KB)
- Polish
  (PDF/53.28 KB)
- Portuguese
  (PDF/39.31 KB)
- Romanian
  (PDF/68.61 KB)
- Slovak
  (PDF/68.56 KB)
- Slovenian
  (PDF/65.75 KB)
- Spanish
  (PDF/39.85 KB)
- Swedish
  (PDF/39.25 KB)

Relvar Ellipta

Table of contents

Overview

Relvar Ellipta : EPAR - Medicine overview (PDF/76.82 KB)

Relvar Ellipta : EPAR - Risk-management-plan summary (PDF/233.76 KB)

Authorisation details

Product information

Relvar Ellipta : EPAR - Product Information (PDF/1.04 MB) (updated)

Relvar Ellipta : EPAR - All Authorised presentations (PDF/22.79 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Relvar Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/260.46 KB) (updated)

Relvar Ellipta-H-C-02673-P46-016 : EPAR - Assessment Report (PDF/2.67 MB)

Relvar Ellipta-H-C-02673-P46-015 : EPAR - Assessment Report (PDF/1004.63 KB)

Relvar Ellipta-H-C-2673-WS-0708 : EPAR - Assessment Report - Variation (PDF/706.83 KB)

Relvar Ellipta-H-C-2673-WS-1208 : EPAR - Assessment Report - Variation (PDF/1.63 MB)

Relvar Ellipta-H-C-2673-P46-0012 : EPAR - Assessment Report (PDF/1.03 MB)

Relvar Ellipta-H-C-2673-P46-0011 : EPAR - Assessment Report (PDF/2.13 MB)

CHMP post-authorisation summary of positive opinion for Relvar Ellipta (WS-1208) (PDF/73.71 KB)

Relvar Ellipta-H-C-2673-A31-14165: EPAR - Assessment Report - Article 31 (PDF/228.27 KB)

Relvar Ellipta : EPAR - Scientific Conclusion (PDF/39.48 KB)

Initial marketing-authorisation documents

Relvar Ellipta : EPAR - Public assessment report (PDF/7.17 MB)

CHMP summary of positive opinion for Relvar Ellipta (PDF/95.09 KB)

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