EMEA-002600-PIP03-21 - paediatric investigation plan

Pegcetacoplan

Key facts

• Invented name:
  Aspaveli
• Active Substance:
  Pegcetacoplan
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0284/2022
• PIP number:
  EMEA-002600-PIP03-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of glomerulonephritis and nephrotic syndrome
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Apellis Ireland Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2022

Decision

P/0284/2022 : EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pegcetacoplan (Aspaveli) (EMEA-002600-PIP03-21)

AdoptedReference Number: EMA/629218/2022