Human normal immunoglobulin - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/195/2011
• PIP number:
  Human normal immunoglobulin
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Idiopathic thrombocytopenic purpura (ITP)
  • Neonatal haemolytic disease (ABO - Rh-incompatability)
  • Primary immunodeficiency (PID)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/07/2011
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000167-PIP01-07-M02
• Compliance opinion date:
  15/10/2012
• Compliance outcome:
  Positive

Decision

P/195/201: EMA decision of 29 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000167-PIP01-07-M02)

Adopted Reference Number: EMA/553360/2011