EMEA-002940-PIP01-20 - paediatric investigation plan

molnupiravir

Key facts

• Active substance:
  molnupiravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  EMA/PE/0000223608
• PIP number:
  EMEA-002940-PIP01-20
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate dosage form, other
• 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:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000223608 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for molnupiravir

Adopted Reference Number: EMADOC-1700519818-1810486