Trixeo Aerosphere


formoterol / glycopyrronium bromide / budesonide

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 04/10/2023

Authorisation details

Product details
Trixeo Aerosphere
Agency product number
Active substance
  • formoterol fumarate dihydrate
  • Glycopyrronium bromide
  • Budesonide
International non-proprietary name (INN) or common name
  • formoterol
  • glycopyrronium bromide
  • budesonide
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address

151 85 Sodertalje

Product information

31/08/2023 Trixeo Aerosphere - EMEA/H/C/004983 - WS2457/G

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Product information documents contain:

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.

Assessment history

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