Bretaris Genuair
aclidinium bromide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Bretaris 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 Bretaris Genuair.
For practical information about using Bretaris Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Bretaris Genuair : EPAR - Summary for the public (PDF/75.86 KB)
First published: 19/09/2012
Last updated: 19/06/2017
EMA/398097/2013 -
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Bretaris Genuair : EPAR - Risk management plan summary (PDF/112.07 KB)
First published: 02/07/2021
Last updated: 02/07/2021
Authorisation details
Product details | |
---|---|
Name |
Bretaris Genuair
|
Agency product number |
EMEA/H/C/002706
|
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 |
Covis Pharma Europe B.V.
|
Revision |
18
|
Date of issue of marketing authorisation valid throughout the European Union |
20/07/2012
|
Contact address |
Gustav Mahlerplein 2 |
Product information
16/12/2022 Bretaris Genuair - EMEA/H/C/002706 - T/0050
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).