Atectura Breezhaler


indacaterol / mometasone

This medicine is authorised for use in the European Union.


Atectura Breezhaler is a medicine that is used to keep the airways open in adults and children aged 12 years and older whose asthma is not adequately controlled with inhaled corticosteroids and inhaled short acting beta-2 agonists. Atectura Breezhaler is used for maintenance (regular) treatment.

The medicine contains the active substances indacaterol and mometasone.

This EPAR was last updated on 08/12/2022

Authorisation details

Product details
Atectura Breezhaler
Agency product number
Active substance
  • indacaterol acetate
  • Mometasone furoate
International non-proprietary name (INN) or common name
  • indacaterol
  • mometasone
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
D04 A9N6 

Product information

01/12/2022 Atectura Breezhaler - EMEA/H/C/005067 - N/0018

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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.

Assessment history

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