EMEA-002963-PIP01-21-M01 - paediatric investigation plan

bemnifosbuvir

Key facts

• Active Substance:
  bemnifosbuvir
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0462/2023
• PIP number:
  EMEA-002963-PIP01-21-M01
• Pharmaceutical form(s):
  • Age-appropriate oral dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023

Decision

P/0462/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bemnifosbuvir (EMEA-002963-PIP01-21-M01)

AdoptedReference Number: EMA/526334/2023