Regulatory PathRegulatory requirements compared

Active substances

Indacaterol + Mometasone

Open in the medicines table

EMA European Union — centrally authorised medicines

Atectura Breezhaler Novartis Europharm Limited · Authorised · authorised 30 May 2020 · ATC R03AK

Therapeutic indication (EMA)

Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Bemrist Breezhaler Novartis Europharm Limited · Authorised · authorised 30 May 2020 · ATC R03AK

Therapeutic indication (EMA)

Bemrist Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ATECTURA BREEZHALER0249868580 MCG; 150 MCGCAPSULE · INHALATIONNOVARTIS PHARMACEUTICALS CANADA INC
ATECTURA BREEZHALER02498693150 MCG; 320 MCGCAPSULE · INHALATIONNOVARTIS PHARMACEUTICALS CANADA INC
ATECTURA BREEZHALER02498707150 MCG; 160 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.