EMEA-002600-PIP03-21-M02 - paediatric investigation plan

Pegcetacoplan

Key facts

• Invented name:
  Aspaveli
• Active Substance:
  Pegcetacoplan
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0195/2024
• PIP number:
  EMEA-002600-PIP03-21-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of glomerulonephritis and nephrotic syndrome
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024

Decision

P/0195/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for pegcetacoplan (Aspaveli), (EMEA-002600-PIP03-21-M02)

AdoptedReference Number: EMA/250115/2024