Is Budesonide + Formoterol + Glycopyrronium 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 Budesonide + Formoterol + Glycopyrronium, including Breztri Aerosphere (5,7.2,160 µg,µg,µg, Pressurised inhalation, suspension, SAR 236.80).

Is Budesonide + Formoterol + Glycopyrronium approved by the US FDA?

Drugs@FDA lists 1 application product line for Budesonide + Formoterol + Glycopyrronium, including BREZTRI AEROSPHERE (Prescription).

Is Budesonide + Formoterol + Glycopyrronium authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Budesonide + Formoterol + Glycopyrronium: Trixeo Aerosphere, Riltrava Aerosphere.

Active substances

Budesonide + Formoterol + Glycopyrronium

SFDA 1
US FDA 1
EMA 2
Health Canada 1
US price lines 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Breztri Aerosphere	5,7.2,160 µg,µg,µg	Pressurised inhalation, suspension · Inhalation use	1 Pressurised container	SAR 236.80	NCE · Prescription	AstraZeneca	Valid

Indications — CHI Daman Drug Formulary

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); GRAFT VERSUS HOST DISEASE

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

Product	Strength	Form · route	Applicant	Status	First approved
BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH; 0.16MG/INH;0.0048MG/INH;0.018MG/INH	aerosol, metered · inhalation	ASTRAZENECA AB	Prescription	23 Jul 2020

EMA European Union — centrally authorised medicines

Trixeo Aerosphere AstraZeneca AB · Authorised · authorised 9 Dec 2020 · ATC R03AL

Therapeutic indication (EMA)

Trixeo Aerosphere 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 beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Riltrava Aerosphere AstraZeneca AB · Authorised · authorised 6 Jan 2022 · ATC R03AL11

Therapeutic indication (EMA)

Riltrava Aerosphere is indicated as a maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long acting beta2 agonist. Riltrava Aerosphere 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 beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BREZTRI AEROSPHERE	02518058	160 MCG / ACT; 7.2 MCG / ACT; 5 MCG / ACT	AEROSOL (METERED-DOSE) · INHALATION	ASTRAZENECA CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BREZTRI AEROSPHERE 160-9-4.8 MCG	$61.30387	per GM	23 Sep 2026
US NADAC	BREZTRI AEROSPHERE 160-9-4.8 MCG	$61.52481	per GM	23 Sep 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.

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.