Hirobriz Breezhaler

Withdrawn

This medicine's authorisation has been withdrawn

indacaterol

Overview

On 30 October 2026, the European Commission withdrew the marketing authorisation for Hirobriz Breezhaler (indacaterol) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Hirobriz Breezhaler was granted marketing authorisation in the EU on 30 November 2009 for the treatment of chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014.

Hirobriz Breezhaler was a duplicate of Onbrez Breezhaler, which is marketed in several EU countries. The withdrawal of Hirobriz Breezhaler is not expected to have any impact on patient access to treatment, as the corresponding reference product, Onbrez Breezhaler, remains authorised and available on the market.

Hirobriz Breezhaler : EPAR - Summary for the public

Product information

Hirobriz Breezhaler : EPAR - Product Information

Hirobriz Breezhaler : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Hirobriz Breezhaler
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/001211
• Marketing authorisation holder:
  Novartis Europharm Limited

  Vista Building; Elm Park; Merrion Road; Dublin 4; D04 A9N6; Ireland

• Opinion adopted:
  24/09/2009
• Marketing authorisation issued:
  30/11/2009
• Withdrawal of marketing authorisation:
  30/10/2026
• Revision:
  21

Assessment history

Changes since initial authorisation of medicine

Hirobriz Breezhaler : EPAR - Procedural steps taken and scientific information after authorisation

Hirobriz Breezhaler : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Hirobriz Breezhaler-PSUSA-00001730-201611 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/677604/2017

Hirobriz Breezhaler-H-C-PSUV-0023 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/CHMP/352675/2016

Hirobriz Breezhaler-H-C-1211-PSU-08 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Initial marketing authorisation documents

Hirobriz Breezhaler : EPAR - Public assessment report

CHMP summary of positive opinion for Hirobriz Breezhaler

Reference Number: EMEA/CHMP/592257/2009