Ulunar Breezhaler

RSS

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 17/05/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
23/04/2014
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

08/05/2018 Ulunar Breezhaler - EMEA/H/C/003875 - T/0024

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

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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