EMEA-003081-PIP01-21-M03 - paediatric investigation plan

nirmatrelvir

nirmatrelvir / ritonavir

Key facts

• Invented name:
  Paxlovid
• Active substance:
  • nirmatrelvir
  • nirmatrelvir / ritonavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0447/2023
• PIP number:
  EMEA-003081-PIP01-21-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral dosage formulation
• Condition(s) / indication(s):
  • Prevention of Coronavirus disease 2019 (COVID-19)
  • 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:
  27/10/2023
• Compliance check done:
  No

Decision

P/0447/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for nirmatrelvir, nirmatrelvir / ritonavir (Paxlovid), (EMEA-003081-PIP01-21-M03)

Adopted Reference Number: EMA/478540/2023