Enurev Breezhaler
Withdrawn
This medicine's authorisation has been withdrawn
glycopyrronium bromide
MedicineHumanWithdrawn
Irish is available via eTranslation, the European Commission's machine translation service.
Translate to Irish | Important information about machine translation
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 30 August 2026, the European Commission withdrew the marketing authorisation for Enurev Breezhaler (Glycopyrronium bromide) 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.
Enurev Breezhaler was granted marketing authorisation in the EU on 28 September 2012 as maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
The withdrawal of Enurev Breezhaler is not expected to have any impact on patient access
to treatment, as the corresponding reference product, Seebri Breezhaler, remains authorised
and available on the market. Patients taking Enurev Breezhaler or participating in a clinical trial are advised to consult their physician.
Product information
Latest procedure affecting product information:VR/0000320523
23/01/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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
- Enurev Breezhaler
- Active substance
- glycopyrronium bromide
- International non-proprietary name (INN) or common name
- glycopyrronium bromide
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03BB06
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
This page was last updated on