Relvar Ellipta

fluticasone furoate / vilanterol

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

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.

How is Relvar 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.

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.

How does Relvar Ellipta work?

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.

What benefits of Relvar Ellipta have been shown in studies?

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 FEV1 by193 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.

What are the risks associated with Relvar Ellipta?

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.

Why is Relvar Ellipta authorised in the EU?

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.

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

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.

Other information about Relvar Ellipta

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

Name Language First published Last updated
Relvar Ellipta : EPAR - Medicine overview BG = bălgarski 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview ES = español 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview CS = čeština 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview DA = dansk 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview DE = Deutsch 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview ET = eesti keel 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview EL = elliniká 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview FR = français 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview IT = italiano 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview LV = latviešu valoda 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview LT = lietuvių kalba 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview HU = magyar 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview MT = Malti 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview NL = Nederlands 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview PL = polski 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview PT = português 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview RO = română 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview SK = slovenčina 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview SL = slovenščina 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview FI = suomi 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview SV = svenska 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Medicine overview HR = Hrvatski 2013-12-10 2018-04-25
Name Language First published Last updated
Relvar Ellipta : EPAR - Risk-management-plan summary (English only) 2018-06-07  

This EPAR was last updated on 07/06/2018 .

Authorisation details

Product details

Product details for Relvar Ellipta
NameRelvar Ellipta
Agency product numberEMEA/H/C/002673
Active substance

fluticasone furoate / vilanterol

International non-proprietary name (INN) or common name

fluticasone furoate / vilanterol

Therapeutic area Pulmonary Disease, Chronic Obstructive
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 Relvar Ellipta
Marketing-authorisation holder

Glaxo Group Ltd

Revision15
Date of issue of marketing authorisation valid throughout the European Union13/11/2013

Contact address:

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

Product information

Product information

12/04/2018  Relvar Ellipta -EMEA/H/C/002673 -WS/1283

Name Language First published Last updated
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25
Relvar Ellipta : EPAR - Product Information EN = English 2013-12-10 2018-04-25

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
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  
Relvar Ellipta : EPAR - All Authorised presentations EN = English 2013-12-10  

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

Name Language First published Last updated
Relvar Ellipta : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2014-08-13 2018-04-25
Relvar Ellipta-H-C-2673-WS-1208 : EPAR - Assessment Report - Variation EN = English 2018-04-25  
Relvar Ellipta-H-C-2673-P46-0011 : EPAR - Assessment Report EN = English 2018-01-30  
Relvar Ellipta-H-C-2673-P46-0012 : EPAR - Assessment Report EN = English 2018-01-30  
CHMP post-authorisation summary of positive opinion for Relvar Ellipta (WS-1208) EN = English 2018-01-26  
Relvar Ellipta-H-C-2673-A31-14165: EPAR - Assessment Report - Article 31 EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  
Relvar Ellipta : EPAR - Scientific Conclusion EN = English 2016-07-15  

Initial marketing-authorisation documents

Name Language First published Last updated
Relvar Ellipta : EPAR - Public assessment report EN = English 2013-12-10  
CHMP summary of positive opinion for Relvar Ellipta EN = English 2013-09-20