EMEA-003121-PIP01-21 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Invented name:
  Flebogamma DIF (previously Flebogammadif)
• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0094/2022
• PIP number:
  EMEA-003121-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of post-polio syndrome
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/03/2022
• Compliance check done:
  Ei

Decision

P/0094/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for human normal immunoglobulin (Flebogamma 5% DIF) (EMEA-003121-PIP01-21)

Adopted Reference Number: EMA/105652/2022