Riltrava Aerosphere


formoterol fumarate dihydrate / glycopyrronium / budesonide

This medicine is authorised for use in the European Union.


Riltrava 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.

Riltrava 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.

Riltrava Aerosphere contains the active substances formoterol, glycopyrronium bromide and budesonide.

This medicine is the same as Trixeo Aerosphere, which is already authorised in the EU. The company that makes Trixeo Aerosphere has agreed that its scientific data can be used for Riltrava Aerosphere (‘informed consent’).

This EPAR was last updated on 20/05/2022

Authorisation details

Product details
Riltrava Aerosphere
Agency product number
Active substance
  • Budesonide
  • formoterol fumarate dihydrate
  • Glycopyrronium bromide
International non-proprietary name (INN) or common name
  • formoterol fumarate dihydrate
  • glycopyrronium
  • 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

AstraZeneca AB
SE-151 85 Sodertalje

Product information

19/05/2022 Riltrava Aerosphere - EMEA/H/C/005311 - IA/0001

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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

Riltrava 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).

Assessment history

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