EMEA-001797-PIP01-15-M01 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0021/2018
• PIP number:
  EMEA-001797-PIP01-15-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Primary Immunodeficiency (PID)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/01/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001797-PIP01-15-M01
• Compliance opinion date:
  21/09/2018
• Compliance outcome:
  Positive

Decision

P/0021/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-001797-PIP01-15-M01)

Adopted Reference Number: EMA/850458/2017