EMEA-003076-PIP01-21 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0501/2021
• PIP number:
  EMEA-003076-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Primary Immunodeficiency (PID)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/12/2021
• Compliance check done:
  No

Decision

P/0501/2021 - EMA decision of 3 December 2021 on the refusal of a paediatric investigation plan and on the granting of a waiver for human normal immunoglobulin (EMEA-003076-PIP01-21)

Adopted Reference Number: EMA/616604/2021