EMEA-003306-PIP01-22 - paediatric investigation plan

obeldesivir

Key facts

• Active Substance:
  obeldesivir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0226/2023
• PIP number:
  EMEA-003306-PIP01-22
• Pharmaceutical form(s):
  • Age-appropriate oral dosage form
  • Film-coated 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:
  14/06/2023

Decision

P/0226/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for obeldesivir (EMEA-003306-PIP01-22)

Reference Number: EMA/236621/2023