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EMA Product

Trixeo Aerosphere

Product approved by European Medicines Agency (EU)

Basic Information

Trixeo Aerosphere

Regulatory Information

EMEA/H/C/004983

Authorised

December 9, 2020

October 15, 2020

6

December 13, 2024

Company Information

Sweden

151 85 Sodertalje

ASTRAZENECA AB

Active Substances Detail

formoterol fumarate dihydrateGlycopyrronium bromideBudesonide

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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