EMEA-001637-PIP01-13 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0047/2014
• PIP number:
  EMEA-001637-PIP01-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Primary Immunodeficiency (PID)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/03/2014
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-001637-PIP01-13
• Compliance opinion date:
  16/01/2015
• Compliance outcome:
  Positive

Decision

P/0047/2014: European Medicines Agency decision of 11 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human normal immunoglobulin (EMEA...

Adopted Reference Number: EMA/58370/2014