Rolufta Ellipta (previously Rolufta) (umeclidinium)
- Region
- 🇪🇺 EU
- Active substance
- umeclidinium
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 26 Jan 2017
- EU approval
- Mon 20 Mar 2017
- Application
- EMEA/H/C/004654
- ATC
- R03BB07
- Official record
- www.ema.europa.eu
Indication
Rolufta 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
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Follow Rolufta Ellipta (previously Rolufta)
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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.