Bretaris Genuair

RSS

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 20/06/2018

Authorisation details

Product details
Name
Bretaris Genuair
Agency product number
EMEA/H/C/002706
Active substance
aclidinium bromide, micronised
International non-proprietary name (INN) or common name
aclidinium bromide
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03BB
Additional 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
AstraZeneca AB
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
20/07/2012
Contact address

Gartunavagen
SE-15185 Sodertalje
Sweden

Product information

18/05/2018 Bretaris Genuair - EMEA/H/C/002706 - N/0037

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

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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