Trixeo Aerosphere
formoterol / glycopyrronium bromide / budesonide
Table of contents
Overview
Trixeo Aerosphere is a medicine used to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD), a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.
Trixeo Aerosphere is used for maintenance (regular) treatment in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist.
Trixeo Aerosphere contains the active substances formoterol, glycopyrronium bromide and budesonide.
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List item
Trixeo Aerosphere : EPAR - Medicine overview (PDF/95.52 KB)
First published: 05/01/2021
EMA/561272/2020 -
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List item
Trixeo Aerosphere : EPAR - Risk-management-plan summary (PDF/67.46 KB)
First published: 05/01/2021
Authorisation details
Product details | |
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Name |
Trixeo Aerosphere
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Agency product number |
EMEA/H/C/004983
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Active substance |
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International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL
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Publication details | |
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Marketing-authorisation holder |
AstraZeneca AB
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
09/12/2020
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Contact address |
151 85 Sodertalje |
Product information
31/08/2023 Trixeo Aerosphere - EMEA/H/C/004983 - WS2457/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
Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.