EMEA-002163-PIP01-17 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0246/2017
• PIP number:
  EMEA-002163-PIP01-17
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Primary Immunodeficiency (PID)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/09/2017
• Compliance check done:
  No

Decision

P/0246/2017: EMA decision of 4 September 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for human normal immunoglobulin (EMEA-002163-PIP01-17)

Adopted Reference Number: EMA/493695/2017