Is Fluticasone + Vilanterol trifenatate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Fluticasone + Vilanterol trifenatate.

Is Fluticasone + Vilanterol trifenatate approved by the US FDA?

Drugs@FDA lists 1 application product line for Fluticasone + Vilanterol trifenatate, including BREO ELLIPTA (Prescription).

Is Fluticasone + Vilanterol trifenatate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fluticasone + Vilanterol trifenatate: Revinty Ellipta.

Active substances

Fluticasone + Vilanterol trifenatate

SFDA 2
US FDA 1
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
RELVAR ELLIPTA 200/25 mcg inhalation powder	200, 25 µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 158.40	NCE · Prescription	GLAXO OPERATION	Withdrawn by MAH · Not Marketed
RELVAR ELLIPTA inhalation powder		Inhalation powder · Inhalation use	1 Inhaler	SAR 158.40	NCE · Prescription	GLAXO OPERATION	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH; 0.2MG/INH;EQ 0.025MG BASE/INH; 0.05MG/INH;EQ 0.025MG BASE/INH	powder · inhalation	GLAXO GRP LTD	Prescription	10 May 2013

EMA European Union — centrally authorised medicines

Revinty Ellipta GlaxoSmithKline Trading Services Limited · Authorised · authorised 2 May 2014 · ATC R03AK10

Therapeutic indication (EMA)

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.

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.