Hirobriz Breezhaler

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indacaterol

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

Overview

This is a summary of the European public assessment report (EPAR) for Hirobriz 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 Hirobriz Breezhaler.

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

This EPAR was last updated on 17/09/2018

Authorisation details

Product details
Name
Hirobriz Breezhaler
Agency product number
EMEA/H/C/001211
Active substance
indacaterol maleate
International non-proprietary name (INN) or common name
indacaterol
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AC18
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
30/11/2009
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

23/08/2018 Hirobriz Breezhaler - EMEA/H/C/001211 - IA/0052

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

Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Assessment history

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