Enerzair Breezhaler
indacaterol / glycopyrronium bromide / mometasone
Table of contents
Overview
Enerzair Breezhaler is an asthma medicine for inhalation. It is used for maintenance (regular) treatment in adults whose asthma is not controlled well enough with inhaled long-acting beta-2 agonist together with a high dose of an inhaled corticosteroid. It should be used for patients who have had at least one asthma attack (exacerbation) in the last year.
Enerzair Breezhaler contains the active substances indacaterol, glycopyrronium bromide and mometasone.
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List item
Enerzair Breezhaler : EPAR - Medicine overview (PDF/97.9 KB)
First published: 21/07/2020
EMA/246032/2020 -
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List item
Enerzair Breezhaler : EPAR - Risk-management-plan summary (PDF/50.23 KB)
First published: 21/07/2020
Authorisation details
Product details | |
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Name |
Enerzair Breezhaler
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Agency product number |
EMEA/H/C/005061
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Asthma
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Anatomical therapeutic chemical (ATC) code |
R03AL
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Date of issue of marketing authorisation valid throughout the European Union |
03/07/2020
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Contact address |
Product information
03/07/2020 Enerzair Breezhaler - EMEA/H/C/005061 -
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
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Pharmacotherapeutic group
Drugs for obstructive airway diseases
Therapeutic indication
Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.