Revinty Ellipta (fluticasone furoate;vilanterol)
- Region
- 🇪🇺 EU
- Active substance
- fluticasone furoate;vilanterol
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Asthma
- CHMP opinion
- Thu 20 Mar 2014
- EU approval
- Fri 02 May 2014
- Application
- EMEA/H/C/002745
- ATC
- R03AK10
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Relvar Ellipta Authorised · GlaxoSmithKline Trading Services Limited
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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.