EMEA-000876-PIP01-10-M01 - paediatric investigation plan

Eculizumab

Key facts

• Invented name:
  • Soliris
  • Soliris
• Active Substance:
  Eculizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0290/2014
• PIP number:
  EMEA-000876-PIP01-10-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of Atypical Haemolytic Uraemic Syndrome
  • Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Alexion Europe SAS

  France; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/10/2014

Decision

P/0290/2014: EMA decision of 24 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris) (EMEA-000876-PIP01-10-M01)

AdoptedReference Number: EMA/642021/2014