Revinty Ellipta

fluticasone furoate / vilanterol

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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’).

: 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.
Revinty Ellipta can only be obtained with a prescription. For more information about using Revinty Ellipta, see the package leaflet or contact your doctor or pharmacist.

: Revinty 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 Revinty Ellipta improves breathing and reduces flare- ups in patients with persistent asthma.
In two of the studies, Revinty 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). Revinty Ellipta 184/22 also improved FEV1by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
In a third study, fewer patients taking Revinty 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 Revinty 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 Revinty Ellipta treatment was able to maintain their FEV1.
COPD
Four studies in over 5,500 patients showed that Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with COPD.
The first study showed that Revinty Ellipta 92/22 improved average FEV1by 115 ml more than placebo, and a second study showed that Revinty Ellipta 184/22 improved average FEV1by 131 ml more than placebo.
In two further studies, Revinty Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.

: The most common side effects with Revinty 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 Revinty Ellipta, see the package leaflet.

: Revinty 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 Revinty 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 Revinty 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 Revinty Ellipta have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Revinty Ellipta are continuously monitored. Side effects reported with Revinty Ellipta are carefully evaluated and any necessary action taken to protect patients.

: Revinty Ellipta received a marketing authorisation valid throughout the EU on 2 May 2014.

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Revinty Ellipta : EPAR - Medicine overview (PDF/83 KB)

First published: 17/06/2014
Last updated: 17/05/2018
EMA/176766/2014
- Bulgarian
  (PDF/106.51 KB)
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  (PDF/98.9 KB)
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  (PDF/75.44 KB)
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  (PDF/75.75 KB)
- Estonian
  (PDF/75.76 KB)
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  (PDF/75.62 KB)
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  (PDF/77.03 KB)
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  (PDF/113.61 KB)
- Hungarian
  (PDF/97.38 KB)
- Italian
  (PDF/75.72 KB)
- Latvian
  (PDF/107.54 KB)
- Lithuanian
  (PDF/100.9 KB)
- Maltese
  (PDF/102.67 KB)
- Polish
  (PDF/101.76 KB)
- Portuguese
  (PDF/76.32 KB)
- Romanian
  (PDF/108.73 KB)
- Slovak
  (PDF/100.38 KB)
- Slovenian
  (PDF/94.99 KB)
- Spanish
  (PDF/76.86 KB)
- Swedish
  (PDF/75.78 KB)
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Revinty Ellipta : EPAR - Risk-management-plan summary (PDF/678.99 KB)

First published: 17/06/2014
Last updated: 06/10/2022

This EPAR was last updated on 02/02/2023

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	GlaxoSmithKline (Ireland) Limited
Revision	21
Date of issue of marketing authorisation valid throughout the European Union	02/05/2014
Contact address	12 Riverwalk Citywest Business Campus Dublin 24 Ireland

Product information

15/09/2022 Revinty Ellipta - EMEA/H/C/002745 - WS/2274

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Revinty Ellipta : EPAR - Product Information (PDF/895.12 KB)

First published: 17/06/2014
Last updated: 10/11/2021
- Bulgarian
  (PDF/1.05 MB)
- Croatian
  (PDF/970.25 KB)
- Czech
  (PDF/945.88 KB)
- Danish
  (PDF/857.23 KB)
- Dutch
  (PDF/694.57 KB)
- Estonian
  (PDF/680.27 KB)
- Finnish
  (PDF/722.48 KB)
- French
  (PDF/985.01 KB)
- German
  (PDF/813.37 KB)
- Greek
  (PDF/946.85 KB)
- Hungarian
  (PDF/958.97 KB)
- Icelandic
  (PDF/754.69 KB)
- Italian
  (PDF/856.55 KB)
- Latvian
  (PDF/1007.83 KB)
- Lithuanian
  (PDF/1.06 MB)
- Maltese
  (PDF/1001.62 KB)
- Norwegian
  (PDF/768.88 KB)
- Polish
  (PDF/975.56 KB)
- Portuguese
  (PDF/1006.83 KB)
- Romanian
  (PDF/997.02 KB)
- Slovak
  (PDF/1.09 MB)
- Slovenian
  (PDF/996.94 KB)
- Spanish
  (PDF/799.8 KB)
- Swedish
  (PDF/836.28 KB)

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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Revinty Ellipta : EPAR - All Authorised presentations (PDF/21.36 KB)

First published: 17/06/2014
Last updated: 17/06/2014
- Bulgarian
  (PDF/60.54 KB)
- Croatian
  (PDF/28.79 KB)
- Czech
  (PDF/39.72 KB)
- Danish
  (PDF/20.5 KB)
- Dutch
  (PDF/21.43 KB)
- Estonian
  (PDF/23.29 KB)
- Finnish
  (PDF/22.39 KB)
- French
  (PDF/20.65 KB)
- German
  (PDF/22.44 KB)
- Greek
  (PDF/45.94 KB)
- Hungarian
  (PDF/35.07 KB)
- Icelandic
  (PDF/20.77 KB)
- Italian
  (PDF/23.37 KB)
- Latvian
  (PDF/43.96 KB)
- Lithuanian
  (PDF/39.79 KB)
- Maltese
  (PDF/40.9 KB)
- Norwegian
  (PDF/22.18 KB)
- Polish
  (PDF/39.11 KB)
- Portuguese
  (PDF/22.15 KB)
- Romanian
  (PDF/35.56 KB)
- Slovak
  (PDF/36.65 KB)
- Slovenian
  (PDF/26.22 KB)
- Spanish
  (PDF/22.42 KB)
- Swedish
  (PDF/20.2 KB)

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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Revinty Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/197.18 KB)

First published: 04/02/2015
Last updated: 06/10/2022
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Revinty Ellipta-H-C-2745-P46-0009 : EPAR - Assessment Report (PDF/2.68 MB)

Adopted

First published: 02/02/2023
EMA/49502/2023
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Revinty Ellipta-H-C-2745-WS-0708 : EPAR - Assessment Report - Variation (PDF/706.83 KB)

Adopted

First published: 28/01/2020
EMA/499766/2015
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Revinty Ellipta-H-C-2745-WS-1208 : EPAR - Assessment Report - Variation (PDF/1.63 MB)

Adopted

First published: 17/05/2018
Last updated: 17/05/2018
EMA/CHMP/187802/2018
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Revinty Ellipta-H-C-2745-P46-0005 : EPAR - Assessment Report (PDF/2.13 MB)

Adopted

First published: 30/01/2018
Last updated: 30/01/2018
EMA/60364/2018
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Revinty Ellipta-H-C-2745-P46-0006 : EPAR - Assessment Report (PDF/1.03 MB)

Adopted

First published: 30/01/2018
Last updated: 30/01/2018
EMA/61080/2018
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CHMP post-authorisation summary of positive opinion for Revinty Ellipta (PDF/73.67 KB)

Adopted

First published: 26/01/2018
Last updated: 26/01/2018
EMA/CHMP/53722/2018
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Revinty Ellipta-H-C-2745-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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Revinty 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)

Revinty Ellipta

Table of contents

Overview

Revinty Ellipta : EPAR - Medicine overview (PDF/83 KB)

Revinty Ellipta : EPAR - Risk-management-plan summary (PDF/678.99 KB)

Authorisation details

Product information

Revinty Ellipta : EPAR - Product Information (PDF/895.12 KB)

Revinty Ellipta : EPAR - All Authorised presentations (PDF/21.36 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Revinty Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/197.18 KB)

Revinty Ellipta-H-C-2745-P46-0009 : EPAR - Assessment Report (PDF/2.68 MB)

Revinty Ellipta-H-C-2745-WS-0708 : EPAR - Assessment Report - Variation (PDF/706.83 KB)

Revinty Ellipta-H-C-2745-WS-1208 : EPAR - Assessment Report - Variation (PDF/1.63 MB)

Revinty Ellipta-H-C-2745-P46-0005 : EPAR - Assessment Report (PDF/2.13 MB)

Revinty Ellipta-H-C-2745-P46-0006 : EPAR - Assessment Report (PDF/1.03 MB)

CHMP post-authorisation summary of positive opinion for Revinty Ellipta (PDF/73.67 KB)

Revinty Ellipta-H-C-2745-A31-14165: EPAR - Assessment Report - Article 31 (PDF/228.27 KB)

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

Initial marketing-authorisation documents

Revinty Ellipta : EPAR - Public assessment report (PDF/252.62 KB)

CHMP summary of positive opinion for Revinty Ellipta (PDF/88.61 KB)

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