EMEA-000876-PIP05-15-M05 - paediatric investigation plan

Eculizumab

Key facts

• Invented name:
  • Soliris
  • Soliris
• Active substance:
  Eculizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0074/2022
• PIP number:
  EMEA-000876-PIP05-15-M05
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-000876-PIP05-15-M05
• Compliance opinion date:
  14/10/2022
• Compliance outcome:
  Positive

Decision

P/0074/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris), (EMEA-000876-PIP05-15-M05)

Adopted Reference Number: EMA/65171/2022