Is Umeclidinium 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 Umeclidinium.

Is Umeclidinium approved by the US FDA?

Drugs@FDA lists 1 application product line for Umeclidinium, including INCRUSE ELLIPTA (Prescription).

Is Umeclidinium authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Umeclidinium: Incruse Ellipta (previously Incruse), Rolufta Ellipta (previously Rolufta).

Is Umeclidinium on the WHO Model List of Essential Medicines?

Yes — 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease (core list): Therapeutic equivalent to tiotropium bromide for Chronic obstructive pulmonary disease.

Are there safety signals or safety updates for Umeclidinium?

US FDA: 3 entries (latest 2023-12-13).

Active substance

Umeclidinium

SFDA 1
US FDA 1
EMA 2
Health Canada 1
US price lines 2
NHS prices 1
WHO EML 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
INCRUSE ELLIPTA 62.5 mcg inhalation powder	62.5 µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 153.15	Generic · Prescription	GLAXO OPERATION	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	powder · inhalation	GLAXO GRP ENGLAND	Prescription	30 Apr 2014

EMA European Union — centrally authorised medicines

Incruse Ellipta (previously Incruse) GlaxoSmithKline Trading Services Limited · Authorised · authorised 28 Apr 2014 · ATC R03BB07

Therapeutic indication (EMA)

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

Rolufta Ellipta (previously Rolufta) GlaxoSmithKline Trading Services Limited · Authorised · authorised 20 Mar 2017 · ATC R03BB07

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
INCRUSE ELLIPTA	02423596	62.5 MCG / ACT	POWDER · INHALATION	GLAXOSMITHKLINE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	INCRUSE ELLIPTA 62.5 MCG INH	$10.27714	per EA	23 Sep 2026
US NADAC	INCRUSE ELLIPTA 62.5 MCG INH	$11.29916	per EA	23 Sep 2026
NHS Drug Tariff	Umeclidinium bromide 65micrograms/dose dry powder inhaler	£27.50	30 dose	1 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 tiotropium bromide for Chronic obstructive pulmonary disease

Safety signals and safety-related labeling changes

US FDA 13 Dec 2023 INCRUSE ELLIPTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2023 ANORO ELLIPTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2023 TRELEGY ELLIPTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for umeclidinium →

Combinations containing Umeclidinium

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.