Revinty Ellipta

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Questions & Answers

On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Revinty Ellipta. The marketing authorisation holder for this medicinal product is Glaxo Group Ltd.

The CHMP adopted an extension to one of the existing indications as follows1:

Asthma

Revinty Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal 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 (Chronic Obstructive Pulmonary Disease)

Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Revinty Ellipta (English only) 2018-01-26  

Key facts

Product details for Revinty Ellipta
NameRevinty Ellipta
INN or common name

fluticasone furoate / vilanterol

Therapeutic area Asthma
Active substance

fluticasone furoate / vilanterol trifenatate

Date opinion adopted25/01/2018
Company name

Glaxo Group Ltd

StatusPositive
Application typePost authorisation