EMEA-000431-PIP01-08-M12 - paediatric investigation plan

vilanterol

fluticasone furoate

Key facts

• Invented name:
  • Relvar Ellipta and associated names
  • Relvar Ellipta
• Active substance:
  • vilanterol
  • fluticasone furoate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0092/2021
• PIP number:
  EMEA-000431-PIP01-08-M12
• Pharmaceutical form(s):
  Inhalation powder (pre-dispensed)
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/03/2021
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000431-PIP01-08-M12
• Compliance opinion date:
  20/01/2023
• Compliance outcome:
  Positive

Decision

P/0092/2021 : EMA decision of 19 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone (furoate) / vilanterol (Relvar Ellipta and associated names) (EMEA-000431-PIP01-08-M12)

Adopted Reference Number: EMA/72934/2021