EMEA-001880-PIP02-19-M04 - paediatric investigation plan

remimazolam besilate

Key facts

• Invented name:
  Byfavo
• Active Substance:
  remimazolam besilate
• Therapeutic area:
  Anaesthesiology
• Decision number:
  P/0110/2023
• PIP number:
  EMEA-001880-PIP02-19-M04
• Pharmaceutical form(s):
  • Powder for solution for injection or infusion
  • Orodispersible film
  • Age-appropriate formulation
• Condition(s) / indication(s):
  • General anaesthesia
  • Sedation
• Route(s) of administration:
  • Intravenous use
  • Buccal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2023

Decision

P/0110/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for remimazolam (besylate) (Byfavo), (EMEA-001880-PIP02-19-M04)

Reference Number: EMA/143773/2023