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)
| Brand | DIN | Strength | Form · route | Company |
| ATECTURA BREEZHALER | 02498685 | 80 MCG; 150 MCG | CAPSULE · INHALATION | NOVARTIS PHARMACEUTICALS CANADA INC |
| ATECTURA BREEZHALER | 02498693 | 150 MCG; 320 MCG | CAPSULE · INHALATION | NOVARTIS PHARMACEUTICALS CANADA INC |
| ATECTURA BREEZHALER | 02498707 | 150 MCG; 160 MCG | CAPSULE · INHALATION | NOVARTIS PHARMACEUTICALS CANADA INC |
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.