欧盟委员会应 Novartis 请求撤回 Hirobriz Breezhaler（indacaterol）上市许可

Application under evaluation
CHMP opinion
European Commission decision

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.

Product information

Latest procedure affecting product information:VR/0000308592

18/11/2025

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Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

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.

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

This page was last updated on 30/10/2026