Bemrist Breezhaler (indacaterol;mometasone)
- Region
- 🇪🇺 EU
- Active substance
- indacaterol;mometasone
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Asthma
- CHMP opinion
- Thu 26 Mar 2020
- EU approval
- Sat 30 May 2020
- Application
- EMEA/H/C/005516
- ATC
- R03AK
- Official record
- www.ema.europa.eu
Indication
Bemrist Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Atectura Breezhaler Authorised · Novartis Europharm Limited
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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.