EMEA-001904-PIP03-18-M02 - paediatric investigation plan

brincidofovir

Key facts

• Active substance:
  brincidofovir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0180/2022
• PIP number:
  EMEA-001904-PIP03-18-M02
• Pharmaceutical form(s):
  • Oral suspension
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of smallpox
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022
• Compliance check done:
  No

Decision

P/0180/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brincidofovir (EMEA- 001904-PIP03-18-M02)

Adopted Reference Number: EMA/205675/2022