Ulunar Breezhaler

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indacaterol / glycopyrronium bromide

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

Overview

This is a summary of the European public assessment report (EPAR) for Ulunar Breezhaler. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ulunar Breezhaler.

For practical information about using Ulunar Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 24/02/2023

Authorisation details

Product details
Name
Ulunar Breezhaler
Agency product number
EMEA/H/C/003875
Active substance
  • Glycopyrronium bromide
  • indacaterol maleate
International non-proprietary name (INN) or common name
  • indacaterol
  • glycopyrronium bromide
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AL04
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
23/04/2014
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

15/11/2021 Ulunar Breezhaler - EMEA/H/C/003875 - IG1424/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
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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

Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Assessment history

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