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Relvar Ellipta (fluticasone furoate;vilanterol)

Region
🇪🇺 EU
Active substance
fluticasone furoate;vilanterol
Company
GlaxoSmithKline Trading Services Limited
Status
Authorised
Therapeutic area
Pulmonary Disease, Chronic Obstructive
CHMP opinion
Thu 19 Sep 2013
EU approval
Wed 13 Nov 2013
Application
EMEA/H/C/002673
ATC
R03AK10
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.