EMEA-000558-PIP01-09-M02 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0091/2014
• PIP number:
  EMEA-000558-PIP01-09-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Treatment of Idiopathic Thrombocytopenia Purpura (ITP)
  • Treatment of Primary Immunodeficiency (PID)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/04/2014
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000558-PIP01-09-M02
• Compliance opinion date:
  23/05/2014
• Compliance outcome:
  Positive

Decision

P/0091/2014: EMA decision of 4 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000558-PIP01-09-M02)

Adopted Reference Number: EMA/169122/2014