Rolufta Ellipta (previously Rolufta)
Active substance: umeclidinium
umeclidinium bromide
Centralised EU authorisationActive
Marketing holder: GlaxoSmithKline Trading Services Limited
Verified 2026-10-09 · EMA
Analogues in other countries- Source: EMA
- Countries with the substance registered: 2
Composition
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| US 6 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208d-1c29-77f8-a791-30ed2985e0c6,01a12090-8de9-7d64-853f-d499dbb9fd1c;count=2 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- EMEA/H/C/004654
- Registration status
- Active
- ATC code
- R03BB07
Sources
- product · EMA · EMEA/H/C/004654 · Verified 2026-10-09
- registration_status · EMA · EMEA/H/C/004654 · Verified 2026-10-09
- ingredients.0 · EMA · EMEA/H/C/004654 · Verified 2026-10-09