Xoterna Breezhaler (indacaterol;glycopyrronium bromide)
- Region
- 🇪🇺 EU
- Active substance
- indacaterol;glycopyrronium bromide
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 25 Jul 2013
- EU approval
- Wed 18 Sep 2013
- Application
- EMEA/H/C/003755
- ATC
- R03AL04
- Official record
- www.ema.europa.eu
Indication
Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Enerzair Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Ultibro Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Ulunar 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.