EMEA-002726-PIP01-19-M03 - paediatric investigation plan

garadacimab

Key facts

• Active substance:
  garadacimab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0048/2023
• PIP number:
  EMEA-002726-PIP01-19-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of hereditary angioedema attacks
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/01/2023
• Compliance check done:
  No

Decision

P/0048/2023 : EMA decision of 30 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for garadacimab (EMEA- 002726-PIP01-19-M03)

Adopted Reference Number: EMA/21395/2023