EMEA-002153-PIP01-17-M01 - paediatric investigation plan

fluticasone furoate

umeclidinium bromide

vilanterol trifenatate

Key facts

• Invented name:
  • Trelegy Ellipta
  • Temybric Ellipta
  • Elebrato Ellipta
• Active substance:
  • fluticasone furoate
  • umeclidinium bromide
  • vilanterol trifenatate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0058/2020
• PIP number:
  EMEA-002153-PIP01-17-M01
• Pharmaceutical form(s):
  Inhalation powder (pre-dispensed)
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  14/02/2020
• Compliance check done:
  Ne

Decision

P/0058/2020: EMA decision of 14 February 2020 on the refusal of a modification of an agreed paediatric investigation plan for fluticasone furoate / umeclidinium bromide / vilanterol trifenatate (Trelegy Ellipta / Elebrato Ellipta / Temybric Ellipta)

Adopted Reference Number: EMA/27242/2020