Temybric Ellipta (fluticasone furoate;umeclidinium;vilanterol)
- Region
- 🇪🇺 EU
- Active substance
- fluticasone furoate;umeclidinium;vilanterol
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Lapsed
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- EU approval
- Wed 12 Jun 2019
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005254
- ATC
- R03AL08
- Official record
- www.ema.europa.eu
Indication
Temybric 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 or a combination of a long-acting ?2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Trelegy Ellipta Authorised · GlaxoSmithKline Trading Services Limited
- 🇪🇺 Elebrato 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.