Daxas (roflumilast)
- Region
- 🇪🇺 EU
- Active substance
- roflumilast
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 22 Apr 2010
- EU approval
- Mon 05 Jul 2010
- Application
- EMEA/H/C/001179
- ATC
- R03DX07
- Official record
- www.ema.europa.eu
Indication
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Libertek Withdrawn · AstraZeneca AB
- 🇪🇺 Daliresp Withdrawn · AstraZeneca AB
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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.