MHRA-100535-PIP01-22-M01 (update)

Key Facts

Active Substance
  • UMECLIDINIUM BROMIDE
  • FLUTICASONE FUROATE
  • VILANTEROL TRIFENATATE
Invented Name
  • Trelegy Ellipta
  • Trelegy Ellipta/ Elebrato/Temybric
  • Trelegy Ellipta
PIP Number MHRA-100535-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Inhalation powder, pre-dispensed
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of asthma
Route(s) of administration
Route(s) of administration:
  • Inhalation use
PIP applicant
  • GlaxoSmithKline UK Limited
  • Country United Kingdom
  • Tel 00442080475000
  • Email oax52639@gsk.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):UMECLIDINIUM BROMIDEFLUTICASONE FUROATEVILANTEROL TRIFENATATE.pdf
Published Date 07/12/2022