EMEA-000775-PIP01-09-M02 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0143/2015
• PIP number:
  EMEA-000775-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:
  10/07/2015
• Compliance check done:
  No

Decision

P/0143/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000775-PIP01-09-M02)

Adopted Reference Number: EMA/382957/2015