Regulatory PathRegulatory requirements compared

Active substances

Glycopyrronium + Indacaterol + Mometasone

Open in the medicines table

EMA European Union — centrally authorised medicines

Enerzair Breezhaler Novartis Europharm Limited · Authorised · authorised 3 Jul 2020 · ATC R03AL

Therapeutic indication (EMA)

Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Zimbus Breezhaler Novartis Europharm Limited · Authorised · authorised 3 Jul 2020 · ATC R03AL

Therapeutic indication (EMA)

Maintenance treatment of asthma in adults whose disease is not adequately controlled.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ENERZAIR BREEZHALER02501244160 MCG; 50 MCG; 150 MCGCAPSULE · INHALATIONNOVARTIS PHARMACEUTICALS CANADA INC

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.