EMA/PE/0000225184 - paediatric investigation plan

nirmatrelvir

ritonavir

Key facts

• Invented name:
  Paxlovid
• Active substance:
  • nirmatrelvir
  • ritonavir
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000225184
• PIP number:
  EMA/PE/0000225184
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral dosage formulation
• 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:
  06/12/2024
• Compliance check done:
  Non

Decision

EMA/PE/0000225184: EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for nirmatrelvir, nirmatrelvir / ritonavir ( Paxlovid)

Adopted Reference Number: EMADOC-1700519818-1788035