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’).
Therapeutic Indication
### 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).
Therapeutic Area (MeSH)
ATC Code
R03AL11
ATC Item
formoterol, glycopyrronium bromide and budesonide
Pharmacotherapeutic Group
Drugs for obstructive airway diseases
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Budesonide | N/A | 布地奈德 |
| formoterol fumarate dihydrate | N/A | Aluminum sulfate |
| Glycopyrronium bromide | N/A | 格隆溴铵 |
| glycopyrronium bromide | N/A | 格隆溴铵 |
EMA Name
Riltrava Aerosphere
Medicine Name
Riltrava Aerosphere
Aliases
N/A