Duaklir Genuair

RSS

aclidinium bromide / formoterol

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

Overview

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

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

This EPAR was last updated on 28/08/2019

Authorisation details

Product details
Name
Duaklir Genuair
Agency product number
EMEA/H/C/003745
Active substance
  • aclidinium bromide
  • formoterol fumarate dihydrate
International non-proprietary name (INN) or common name
aclidinium bromide / formoterol
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AL
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
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
19/11/2014
Contact address
SE-151-85 Sodertalje
Sweden

Product information

23/08/2019 Duaklir Genuair - EMEA/H/C/003745 - PSUSA/00010307/201811

Contents

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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

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

Assessment history

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