EMEA-000876-PIP03-14-M06 - paediatric investigation plan

Eculizumab

Key facts

• Invented name:
  Soliris
• Active substance:
  Eculizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0124/2023
• PIP number:
  EMEA-000876-PIP03-14-M06
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of neuromyelitis optica spectrum disorders
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2023
• Compliance check done:
  Ei

Decision

P/0124/2023 : EMA decision of 14 April 2023 on the refusal of a modification of an agreed paediatric investigation plan for eculizumab (Soliris), (EMEA-000876-PIP03-14-M06)

Adopted Reference Number: EMA/134196/2023