EMEA-003192-PIP02-23 - paediatric investigation plan

ensitrelvir

Key facts

• Active Substance:
  ensitrelvir
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0242/2024
• PIP number:
  EMEA-003192-PIP02-23
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/07/2024

Decision

P/0242/2024: EMA decision of 19 July 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for ensitrelvir, (EMEA-003192-PIP02-23)

AdoptedReference Number: EMA/323235/2024