EMEA-003506-PIP01-23 - paediatric investigation plan

doruxapapogenum ralaplasmidum

Key facts

• Active substance:
  doruxapapogenum ralaplasmidum
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0391/2024
• PIP number:
  EMEA-003506-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of recurrent respiratory papillomatosis
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

P/0391/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for doruxapapogenum ralaplasmidum, (EMEA-003506-PIP01-23)

Adopted Reference Number: EMA/552735/2024