EMEA-002940-PIP01-20 - paediatric investigation plan

Molnupiravir

Key facts

• Active Substance:
  Molnupiravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0345/2021
• 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
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/08/2021

Decision

P/0345/2021: EMA decision of 12 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for molnupiravir (EMEA-002940-PIP01-20)

Reference Number: EMA/444418/2021