Enerzair Breezhaler (indacaterol;glycopyrronium bromide;mometasone)
- Region
- 🇪🇺 EU
- Active substance
- indacaterol;glycopyrronium bromide;mometasone
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Asthma
- CHMP opinion
- Thu 07 Sep 2023
- EU approval
- Fri 03 Jul 2020
- Application
- EMEA/H/C/005061
- ATC
- R03AL
- Official record
- www.ema.europa.eu
Indication
Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.
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.