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fluticasone furoate/umeclidinium/vilanterol

Elebrato Ellipta, Trelegy Ellipta · ATC code R03AL08

Also known as: Fluticasonfuroat/Umeclidinium/Vilanterol, Flutikazon furoat/umeklidinyum/vilanterol, Fluticasone Furoate / Umeclidinium / Vilanterol

Key facts
Active substance
fluticasone furoate/umeclidinium/vilanterol (INN: fluticasone furoate / umeclidinium / vilanterol)
ATC code
R03AL08
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed · Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited
Information as of
2026-10-28

Key facts

Fluticasone furoate/umeclidinium/vilanterol is an inhaled triple combination of a corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-agonist. It is used as maintenance treatment of COPD in adults.

What it is used for

  • Maintenance treatment in adults with moderate to severe COPD not adequately treated by an inhaled corticosteroid plus long-acting beta2-agonist, or a long-acting beta2-agonist plus long-acting muscarinic antagonist (Elebrato Ellipta, Trelegy Ellipta).

Dosing

  • Elebrato Ellipta and Trelegy Ellipta: recommended and maximum dose is one inhalation once daily, at the same time each day.
  • Missed dose: inhale the next dose at the usual time the next day.
  • No dose adjustment in the elderly, renal impairment or hepatic impairment; use with caution in moderate to severe hepatic impairment.
  • For inhalation only; the inhaler should not be shaken. No relevant use in patients under 18 years of age.

Contraindications

  • Hypersensitivity to the active substances or any of the excipients.

Important warnings

  • Not to be used in asthma (not studied); not for acute bronchospasm or acute COPD exacerbations.
  • Paradoxical bronchospasm, which may be life-threatening: stop immediately.
  • Cardiovascular effects such as atrial fibrillation and tachycardia; caution in unstable or life-threatening cardiovascular disease.
  • Increased incidence of pneumonia in COPD patients receiving inhaled corticosteroids.
  • Caution in narrow-angle glaucoma and urinary retention; visual disturbance may indicate cataract, glaucoma or CSCR.
  • Do not stop without physician supervision.

Side effects

  • Most frequent: nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
  • Also common: pneumonia, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, oral and throat candidiasis, urinary tract infection. See the full text for more.

Interactions

  • Beta-blockers may weaken the effect of vilanterol; if needed, consider cardioselective beta-blockers.
  • Fluticasone furoate and vilanterol are metabolised by CYP3A4; strong CYP3A4 inhibitors may increase systemic exposure - see the full text.

Pregnancy and breastfeeding

  • Limited data; use in pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
  • Breast-feeding: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Turkey

  • Trelegy ElliptaGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 6 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Elebrato Ellipta, Trelegy Ellipta
Liechtenstein
Elebrato Ellipta, Trelegy Ellipta
Norway
Elebrato Ellipta, Trelegy Ellipta

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Elebrato Ellipta – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/elebrato-ellipta-epar-product-information_en.pdf
  2. European Medicines Agency. Trelegy Ellipta – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/trelegy-ellipta-epar-product-information_en.pdf
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.