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 26/09/2023

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
Covis Pharma Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Gustav Mahlerplein 2
1082 MA Amsterdam
The Netherlands

Product information

25/09/2023 Brimica Genuair - EMEA/H/C/003969 - N/0040

Other EU languages available icon This medicine’s product information is available in all official EU languages.
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Product information documents contain:

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

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

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