Brimica Genuair

RSS

aclidinium / formoterol fumarate dihydrate

Authorised
This medicine is authorised for use in the European Union.

Overview

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 21/06/2018

Authorisation details

Product details
Name
Brimica Genuair
Agency product number
EMEA/H/C/003969
Active substance
  • aclidinium
  • formoterol fumarate dihydrate
International non-proprietary name (INN) or common name
aclidinium / formoterol fumarate dihydrate
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AL05
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
10
Date of issue of marketing authorisation valid throughout the European Union
19/11/2014
Contact address
51 85 Södertalje
Sweden

Product information

18/05/2018 Brimica Genuair - EMEA/H/C/003969 - N/0022

Contents

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

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