Is Fluticasone + Umeclidinium + Vilanterol trifenatate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Fluticasone + Umeclidinium + Vilanterol trifenatate, including Trelegy Ellipta (200,62.5,25 µg, Inhalation powder, pre-dispensed, SAR 236.80).

Is Fluticasone + Umeclidinium + Vilanterol trifenatate authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Fluticasone + Umeclidinium + Vilanterol trifenatate: Trelegy Ellipta, Elebrato Ellipta.

Active substances

Fluticasone + Umeclidinium + Vilanterol trifenatate

SFDA 1
US FDA 1
EMA 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Trelegy Ellipta	200,62.5,25 µg	Inhalation powder, pre-dispensed · Inhalation use	1 Inhaler	SAR 236.80	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TRELEGY ELLIPTA	0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH; 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	powder · inhalation	GLAXOSMITHKLINE	Prescription	18 Sep 2017

EMA European Union — centrally authorised medicines

Trelegy Ellipta GlaxoSmithKline Trading Services Limited · Authorised · authorised 15 Nov 2017 · ATC R03AL08

Therapeutic indication (EMA)

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.

Elebrato Ellipta GlaxoSmithKline Trading Services Limited · Authorised · authorised 15 Nov 2017 · ATC R03AL08

Therapeutic indication (EMA)

Elebrato 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.

Temybric Ellipta GlaxoSmithKline Trading Services Limited · Lapsed · authorised 12 Jun 2019 · ATC R03AL08

Therapeutic indication (EMA)

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).

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.