Regulatory PathRegulatory requirements compared

Active substances

Beclometasone + Formoterol + Glycopyrronium

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Trimbow87,9,5 µg,µg,µgPressurised inhalation, solution · Inhalation use1 Aluminum CanSAR 236.80NCE · PrescriptionCHIESI FARMACEUTICISValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
TRIMBOW0.086MG/INH;0.0049MG/INH;0.0106MG/INH; 0.172MG/INH;0.0049MG/INH;0.0106MG/INHaerosol, metered · inhalationCHIESIPrescription14 May 2026

EMA European Union — centrally authorised medicines

Trimbow Chiesi Farmaceutici S.p.A. · Authorised · authorised 17 Jul 2017 · ATC R03AL09

Therapeutic indication (EMA)

Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. COPDMaintenance 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 a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1). AsthmaMaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Trydonis Chiesi Farmaceutici S.p.A. · Authorised · authorised 26 Apr 2018 · ATC R03AL09

Therapeutic indication (EMA)

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 (for effects on symptoms control and prevention of exacerbations see section 5.1).

Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) Chiesi Farmaceutici S.p.A. · Withdrawn · authorised 23 Apr 2018 · ATC R03AL09

Therapeutic indication (EMA)

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 (for effects on symptoms control and prevention of exacerbations see section 5.1).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
TRIMBOW025575926 MCG / ACT; 100 MCG / ACT; 10 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONCHIESI FARMACEUTICI S.P.A.

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.