EMEA-003395-PIP02-23 - paediatric investigation plan

iodine (131I) apamistamab

Key facts

• Active substance:
  iodine (131I) apamistamab
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  P/0122/2024
• PIP number:
  EMEA-003395-PIP02-23
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment in allogenic stem cell transplantation
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/04/2024
• Compliance check done:
  Nej

Decision

P/0122/2024: EMA decision of 11 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for iodine (131I) apamistamab (EMEA-003395-PIP02-23)

Adopted Reference Number: EMA/142648/2024