Trixeo Aerosphere - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

formoterol / glycopyrronium bromide / budesonide

Opinion

On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Trixeo Aerosphere. The marketing authorisation holder for this medicinal product is AstraZeneca AB.

The CHMP adopted a new strength of the pressurised inhalation suspension (5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 18 micrograms, equivalent to 14.4 micrograms of glycopyrronium, and budesonide 160 micrograms) associated with a new indication as follows:

Trixeo Aerosphere is indicated as a maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long-acting beta2-agonist.

For information, the full indications for Trixeo Aerosphere will be as follows:

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 (for effects on symptoms control and prevention of exacerbations see section 5.1).

Trixeo Aerosphere is indicated as a maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long-acting beta2-agonist.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold.

CHMP post-authoirsation summary of positive opinion for Trixeo Aerosphere (X-0000287664)

Adopted Reference Number: EMADOC-1700519818-3341902

Key facts

• Name of medicine:
  Trixeo Aerosphere
• EMA product number:
  EMEA/H/C/004983
• 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 therapeutical chemical (ATC) code:
  R03AL
• Marketing authorisation holder:
  AstraZeneca AB
• Date of opinion:
  23/07/2026
• Status:
  Positive