Bretaris Genuair

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aclidinium 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 Bretaris Genuair. 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 Bretaris Genuair.

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

This EPAR was last updated on 05/01/2023

Authorisation details

Product details
Name
Bretaris Genuair
Agency product number
EMEA/H/C/002706
Active substance
aclidinium bromide
International non-proprietary name (INN) or common name
aclidinium bromide
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03BB
Additional monitoringAdditional 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
Covis Pharma Europe B.V.
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
20/07/2012
Contact address

Gustav Mahlerplein 2
1082 MA Amsterdam
The Netherlands

Product information

16/12/2022 Bretaris Genuair - EMEA/H/C/002706 - T/0050

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Assessment history

Changes since initial authorisation of medicine

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