EMEA-002940-PIP02-21 - paediatric investigation plan

Molnupiravir

Key facts

• Active substance:
  Molnupiravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0553/2021
• PIP number:
  EMEA-002940-PIP02-21
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate dosage form
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/12/2021
• Compliance check done:
  No

Decision

P/0553/2021 : EMA decision of 31 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for molnupiravir (EMEA-002940-PIP02-21)

Adopted Reference Number: EMA/707172/2021