EMEA-002818-PIP01-20-M01 - paediatric investigation plan

Human plasma derived C1-inhibitor (OCTA-C1-INH)

Key facts

• Active substance:
  Human plasma derived C1-inhibitor (OCTA-C1-INH)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0323/2024
• PIP number:
  EMEA-002818-PIP01-20-M01
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0323/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for human plasma derived C1-inhibitor (OCTA-C1-INH), (EMEA-002818-PIP01-20-M01)

Adopted Reference Number: EMA/411619/2024