EMEA-003192-PIP03-23 - paediatric investigation plan

ensitrelvir

Key facts

• Active substance:
  ensitrelvir
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMEA-003192-PIP03-23
• PIP number:
  EMEA-003192-PIP03-23
• Pharmaceutical form(s):
  • Granules
  • Tablet
• Condition(s) / indication(s):
  Prevention of post-exposure prophylaxis 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:
  12/02/2025
• Compliance check done:
  Nie

Decision

EMEA-003192-PIP03-23 : EMA decision of 12 February 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for ensitrelvir

Adopted Reference Number: EMADOC-1700519818-1907112