EMEA-003033-PIP02-22 - paediatric investigation plan

pabinafusp alfa

Key facts

• Active substance:
  pabinafusp alfa
• Therapeutic area:
  Other
• Decision number:
  P/0438/2023
• PIP number:
  EMEA-003033-PIP02-22
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of mucopolysaccharidosis II
• 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:
  27/10/2023
• Compliance check done:
  No

Decision

P/0438/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for pabinafusp alfa (EMEA-003033-PIP02-22)

Adopted Reference Number: EMA/401556/2023