Atectura Breezhaler

RSS

indacaterol / mometasone

Authorised
This medicine is authorised for use in the European Union.

Overview

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 23/06/2020

Authorisation details

Product details
Name
Atectura Breezhaler
Agency product number
EMEA/H/C/005067
Active substance
  • indacaterol acetate
  • Mometasone furoate
International non-proprietary name (INN) or common name
  • indacaterol
  • mometasone
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03AK
Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Date of issue of marketing authorisation valid throughout the European Union
30/05/2020
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

30/05/2020 Atectura Breezhaler - EMEA/H/C/005067 -

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating