Zimbus Breezhaler
indacaterol / glycopyrronium / mometasone furoate
Table of contents
Overview
Zimbus 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 (exacerbations) in the last year.
Zimbus Breezhaler contains the active substances indacaterol, glycopyrronium bromide and mometasone.
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Zimbus Breezhaler : EPAR - Medicine Overview (PDF/97.83 KB)
First published: 02/09/2020
EMA/246035/2020 -
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Zimbus Breezhaler : EPAR - Risk-management-plan summary (PDF/50.29 KB)
First published: 02/09/2020
Authorisation details
Product details | |
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Name |
Zimbus Breezhaler
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Agency product number |
EMEA/H/C/005518
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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 Zimbus Breezhaler - EMEA/H/C/005518 -
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
Maintenance treatment of asthma in adults whose disease is not adequately controlled.