Is Umeclidinium + Vilanterol trifenatate approved by the US FDA?

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

Is Umeclidinium + Vilanterol trifenatate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Umeclidinium + Vilanterol trifenatate: Anoro Ellipta (previously Anoro).

Active substances

Umeclidinium + Vilanterol trifenatate

US FDA 1
EMA 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	powder · inhalation	GLAXOSMITHKLINE	Prescription	18 Dec 2013

EMA European Union — centrally authorised medicines

Anoro Ellipta (previously Anoro) GlaxoSmithKline Trading Services Limited · Authorised · authorised 8 May 2014 · ATC R03AL03

Therapeutic indication (EMA)

Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

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.