Zimbus Breezhaler

RSS

indacaterol / glycopyrronium / mometasone furoate

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

Overview

Zimbus 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 (exacerbations) in the last year.

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

This EPAR was last updated on 02/09/2020

Authorisation details

Product details
Name
Zimbus Breezhaler
Agency product number
EMEA/H/C/005518
Active substance
  • Glycopyrronium bromide
  • Indacaterol (acetate)
  • Mometasone furoate
International non-proprietary name (INN) or common name
  • indacaterol
  • glycopyrronium
  • mometasone furoate
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 Zimbus Breezhaler - EMEA/H/C/005518 -

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Maintenance treatment of asthma in adults whose disease is not adequately controlled.

Assessment history

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