EMEA-003363-PIP01-22 - paediatric investigation plan

ruzotolimod

Key facts

• Active substance:
  ruzotolimod
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0444/2023
• PIP number:
  EMEA-003363-PIP01-22
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of chronic hepatitis B
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0444/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ruzotolimod, (EMEA-003363-PIP01-22)

Adopted Reference Number: EMA/470008/2023