Eklira Genuair
aclidinium bromide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Eklira 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 Eklira Genuair.
For practical information about using Eklira Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Eklira Genuair : EPAR - Summary for the public (PDF/95.32 KB)
First published: 19/09/2012
Last updated: 19/06/2017
EMA/484680/2013 -
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Eklira Genuair : EPAR - Risk-management-plan summary (PDF/416.5 KB)
First published: 01/12/2020
Authorisation details
Product details | |
---|---|
Name |
Eklira Genuair
|
Agency product number |
EMEA/H/C/002211
|
Active substance |
aclidinium bromide
|
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 | |
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Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
17
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Date of issue of marketing authorisation valid throughout the European Union |
20/07/2012
|
Contact address |
Product information
29/10/2020 Eklira Genuair - EMEA/H/C/002211 - WS/1795
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
Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).