Trimbow (beclometasone;formoterol;glycopyrronium bromide)
- Region
- 🇪🇺 EU
- Active substance
- beclometasone;formoterol;glycopyrronium bromide
- Company
- Chiesi Farmaceutici S.p.A.
- Status
- Authorised
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 18 May 2017
- EU approval
- Mon 17 Jul 2017
- Application
- EMEA/H/C/004257
- ATC
- R03AL09
- Official record
- www.ema.europa.eu
Indication
Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. COPDMaintenance 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 a 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). AsthmaMaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
Regulatory milestones
FDA approves Trimbow (beclomethasone dipropionate, formoterol fumarate, glycopyrrolate): new combination
Chiesi; NDA219622; New combination; aerosol, metered · source
Same substance in other markets
- 🇪🇺 Trydonis Authorised · Chiesi Farmaceutici S.p.A.
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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.