EMEA-000876-PIP02-11-M01 - paediatric investigation plan

Eculizumab

Key facts

• Invented name:
  • Soliris
  • Soliris
• Active substance:
  Eculizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0306/2012
• PIP number:
  EMEA-000876-PIP02-11-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Shiga-toxin-producing Escherichia coli haemolytic uraemic syndrome
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/12/2012
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-000876-PIP01-10-M01
• Compliance opinion date:
  02/06/2015
• Compliance outcome:
  Positive

Decision

P/0306/2012: EMA decision of 21 December 2012 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris) (EMEA-000876-PIP02-11-M01)

Adopted Reference Number: EMA/792272/2012