Ulunar Breezhaler
indacaterol / glycopyrronium bromide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Ulunar Breezhaler. 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 Ulunar Breezhaler.
For practical information about using Ulunar Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Ulunar Breezhaler : EPAR - Summary for the public (PDF/77.63 KB)
First published: 16/05/2014
Last updated: 16/05/2014
EMA/288552/2014 -
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Ulunar Breezhaler : EPAR - Risk-management-plan summary (PDF/165.57 KB)
First published: 16/05/2014
Last updated: 03/05/2018
Authorisation details
Product details | |
---|---|
Name |
Ulunar Breezhaler
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Agency product number |
EMEA/H/C/003875
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Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL04
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
23/04/2014
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Contact address |
Vista Building |
Product information
15/11/2021 Ulunar Breezhaler - EMEA/H/C/003875 - IG1424/G
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
Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).