EMEA-002600-PIP01-19-M02 - paediatric investigation plan

pegcetacoplan

Key facts

• Invented name:
  Aspaveli
• Active substance:
  pegcetacoplan
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0099/2024
• PIP number:
  EMEA-002600-PIP01-19-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/04/2024
• Compliance check done:
  No

Decision

P/0099/2024 : EMA decision of 5 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for pegcetacoplan (Aspaveli), (EMEA-002600-PIP01-19-M02)

Adopted Reference Number: EMA/139620/2024