Revinty Ellipta

fluticasone furoate / vilanterol

  • Email
  • Help

About

An overview of Revinty Ellipta and why it is authorised in the EU

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’).

How is Revinty Ellipta used?

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.

How does Revinty Ellipta work?

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.

What benefits of Revinty Ellipta have been shown in studies?

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.

What are the risks associated with Revinty Ellipta?

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.

Why is Revinty Ellipta authorised in the EU?

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.

What measures are being taken to ensure the safe and effective use of Revinty Ellipta?

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.

Other information about Revinty Ellipta

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

Name Language First published Last updated
Revinty Ellipta : EPAR - Medicine overview BG = bălgarski 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview ES = español 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview CS = čeština 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview DA = dansk 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview DE = Deutsch 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview ET = eesti keel 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview EL = elliniká 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview FR = français 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview IT = italiano 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview LV = latviešu valoda 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview LT = lietuvių kalba 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview HU = magyar 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview MT = Malti 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview NL = Nederlands 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview PL = polski 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview PT = português 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview RO = română 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview SK = slovenčina 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview SL = slovenščina 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview FI = suomi 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview SV = svenska 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Medicine overview HR = Hrvatski 2014-06-17 2018-05-17
Name Language First published Last updated
Revinty Ellipta : EPAR - Risk-management-plan summary (English only) 2014-06-17  

This EPAR was last updated on 17/05/2018 .

Authorisation details

Product details

Product details for Revinty Ellipta
NameRevinty Ellipta
Agency product numberEMEA/H/C/002745
Active substance

fluticasone furoate / vilanterol trifenatate

International non-proprietary name (INN) or common name

fluticasone furoate / vilanterol

Therapeutic area Asthma
Anatomical therapeutic chemical (ATC) code R03AK10
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Revinty Ellipta
Marketing-authorisation holder

Glaxo Group Ltd

Revision12
Date of issue of marketing authorisation valid throughout the European Union02/05/2014

Contact address:

Glaxo Group Ltd
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
 

Product information

Product information

10/04/2018  Revinty Ellipta -EMEA/H/C/002745 -N/0034

Name Language First published Last updated
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17
Revinty Ellipta : EPAR - Product Information EN = English 2014-06-17 2018-05-17

Contents

  • 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

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.


Name Language First published Last updated
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  
Revinty Ellipta : EPAR - All Authorised presentations EN = English 2014-06-17  

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

Name Language First published Last updated
Revinty Ellipta : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-02-04 2018-05-17
Revinty Ellipta-H-C-2745-WS-1208 : EPAR - Assessment Report - Variation EN = English 2018-05-17  
Revinty Ellipta-H-C-2745-P46-0005 : EPAR - Assessment Report EN = English 2018-01-30  
Revinty Ellipta-H-C-2745-P46-0006 : EPAR - Assessment Report EN = English 2018-01-30  
CHMP post-authorisation summary of positive opinion for Revinty Ellipta EN = English 2018-01-26  
Revinty Ellipta-H-C-2745-A31-14165: EPAR - Assessment Report - Article 31 EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Revinty Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  

Initial marketing-authorisation documents

Name Language First published Last updated
Revinty Ellipta : EPAR - Public assessment report EN = English 2014-06-17  
CHMP summary of positive opinion for Revinty Ellipta EN = English 2014-03-21