EMEA-001290-PIP01-12-M01 - paediatric investigation plan

human normal immunoglobulin (SCNG20%)

Key facts

• Active Substance:
  human normal immunoglobulin (SCNG20%)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0303/2024
• PIP number:
  EMEA-001290-PIP01-12-M01
• Pharmaceutical form(s):
  Solution for infusion
• 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:
  16/08/2024

Decision

P/0303/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (SCNG20%) (EMEA-001290-PIP01-12-M01)

AdoptedReference Number: EMA/320731/2024