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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
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 6
  • Anoro Ellipta
    POWDER · UMECLIDINIUM BROMIDE 62.5 ug/1, VILANTEROL TRIFENATATE 25 ug/1
    0173-0869
    GlaxoSmithKline LLC
  • Incruse Ellipta
    AEROSOL, POWDER · UMECLIDINIUM BROMIDE 62.5 ug/1
    0173-0873
    GlaxoSmithKline LLC
  • Trelegy Ellipta
    POWDER · FLUTICASONE FUROATE 200 ug/1, UMECLIDINIUM BROMIDE 62.5 ug/1, VILANTEROL TRIFENATATE 25 ug/1
    0173-0893
    GlaxoSmithKline LLC
  • Trelegy Ellipta
    POWDER · FLUTICASONE FUROATE 100 ug/1, UMECLIDINIUM BROMIDE 62.5 ug/1, VILANTEROL TRIFENATATE 25 ug/1
    0173-0887
    GlaxoSmithKline LLC
  • Umeclidinium Ellipta
    AEROSOL, POWDER · UMECLIDINIUM BROMIDE 62.5 ug/1
    66993-189
    Prasco Laboratories
All products in this country (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

More on control status
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