Brimica Genuair


aclidinium / formoterol fumarate dihydrate

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Brimica 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 Brimica Genuair.

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

This EPAR was last updated on 29/08/2019

Authorisation details

Product details
Brimica Genuair
Agency product number
Active substance
  • formoterol fumarate dihydrate
  • aclidinium bromide
International non-proprietary name (INN) or common name
  • aclidinium
  • formoterol fumarate dihydrate
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
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
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address
51 85 Södertalje

Product information

23/08/2019 Brimica Genuair - EMEA/H/C/003969 - PSUSA/00010307/201811


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

Brimica Genuair is indicated as a maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Assessment history

How useful was this page?

Add your rating
1 rating