Riltrava Aerosphere (formoterol fumarate dihydrate;glycopyrronium;budesonide)
- Region
- 🇪🇺 EU
- Active substance
- formoterol fumarate dihydrate;glycopyrronium;budesonide
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Thu 06 Jan 2022
- Application
- EMEA/H/C/005311
- ATC
- R03AL11
- Official record
- www.ema.europa.eu
Indication
Riltrava 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. 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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.