Enerzair Breezhaler

RSS

indacaterol / glycopyrronium bromide / mometasone

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

Overview

Enerzair Breezhaler is an asthma medicine for inhalation. It is used for maintenance (regular) treatment in adults whose asthma is not controlled well enough with inhaled long-acting beta-2 agonist together with a high dose of an inhaled corticosteroid. It should be used for patients who have had at least one asthma attack (exacerbation) in the last year.

Enerzair Breezhaler contains the active substances indacaterol, glycopyrronium bromide and mometasone.

This EPAR was last updated on 21/07/2020

Authorisation details

Product details
Name
Enerzair Breezhaler
Agency product number
EMEA/H/C/005061
Active substance
  • indacaterol
  • glycopyrronium bromide
  • mometasone
International non-proprietary name (INN) or common name
  • indacaterol
  • glycopyrronium bromide
  • mometasone
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03AL
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
03/07/2020
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

03/07/2020 Enerzair Breezhaler - EMEA/H/C/005061 -

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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.

Assessment history

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