Regulatory PathRegulatory requirements compared

Active substances

Fluticasone + Vilanterol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RELVAR ELLIPTA100,25 µg,µgInhalation powder · Inhalation use1 InhalerSAR 158.40NCE · PrescriptionGlaxo Saudi Arabia Ltd.Valid
RELVAR ELLIPTA 200/25 mcg inhalation powder200,25 µg,µgInhalation powder · Inhalation use1 InhalerSAR 158.40NCE · PrescriptionGlaxo Saudi Arabia Ltd.Valid
Indications — CHI Daman Drug Formulary

ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

EMA European Union — centrally authorised medicines

Relvar Ellipta GlaxoSmithKline Trading Services Limited · Authorised · authorised 13 Nov 2013 · ATC R03AK10

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BREO ELLIPTA02408872100 MCG / ACT; 25 MCG / ACTPOWDER · INHALATIONGLAXOSMITHKLINE INC
BREO ELLIPTA0244418625 MCG / ACT; 200 MCG / ACTPOWDER · INHALATIONGLAXOSMITHKLINE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFLUTICASONE-VILANTEROL 100-25$3.8971per EA23 Sep 2026
US NADACFLUTICASONE-VILANTEROL 200-25$3.91371per EA23 Sep 2026
NHS Drug TariffFluticasone furoate 184micrograms/dose / Vilanterol 22micrograms/dose dry powder inhaler£29.5030 dose1 Oct 2026
NHS Drug TariffFluticasone furoate 92micrograms/dose / Vilanterol 22micrograms/dose dry powder inhaler£22.0030 dose1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
    Therapeutic equivalent to budesonide + formoterol for Asthma

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.