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EMA Product

Ultibro Breezhaler

Product approved by European Medicines Agency (EU)

Basic Information

Ultibro Breezhaler

Regulatory Information

EMEA/H/C/002679

Authorised

September 19, 2013

15

March 3, 2025

Company Information

Ireland

Vista Building Elm Park Merrion Road Dublin 4

NOVARTIS EUROPHARM LIMITED

Active Substances Detail

indacaterolGlycopyrronium bromide

Detailed Information

Therapeutic Indication

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

Overview Summary

This is a summary of the European public assessment report (EPAR) for Ultibro Breezhaler. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Ultibro Breezhaler. For practical information about using Ultibro Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.

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