Relvar Ellipta granted authorisation change.

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 Relvar Ellipta (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI), from Glaxo Group.

The CHMP adopted an extension to one of the existing indications as follows: Relvar 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.