EMEA-001110-PIP01-10-M01 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0138/2012
• PIP number:
  EMEA-001110-PIP01-10-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Treatment of chronic inflammatory demyelinating polyradiculo-neuropathy
  • Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation
  • Treatment of primary immunodeficiency (PID) as model for replacement therapy
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/07/2012
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001110-PIP01-10-M01
• Compliance opinion date:
  11/10/2013
• Compliance outcome:
  Positive

Decision

P/0138/2012: EMA decision of 20 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-001110-PIP01-10-M01)

Adopted Reference Number: EMA/469914/2012