Trelegy Ellipta (fluticasone furoate;umeclidinium;vilanterol)
- Region
- 🇪🇺 EU
- Active substance
- fluticasone furoate;umeclidinium;vilanterol
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 14 Sep 2017
- EU approval
- Wed 15 Nov 2017
- Application
- EMEA/H/C/004363
- ATC
- R03AL08
- Official record
- www.ema.europa.eu
Indication
Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Elebrato Ellipta Authorised · GlaxoSmithKline Trading Services Limited
- 🇪🇺 Temybric Ellipta Lapsed · GlaxoSmithKline Trading Services Limited
Follow Trelegy Ellipta
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.