EMEA-001864-PIP01-15-M07 - paediatric investigation plan

Lanadelumab (DX-2930)

Key facts

• Invented name:
  Takhzyro
• Active Substance:
  Lanadelumab (DX-2930)
• Therapeutic area:
  Other
• Decision number:
  P/0214/2022
• PIP number:
  EMEA-001864-PIP01-15-M07
• 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:
  10/06/2022
• Compliance procedure number:
  EMEA-C-001864-PIP01-15-M07
• Compliance opinion date:
  09/09/2022
• Compliance outcome:
  Positive

Decision

P/0214/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lanadelumab (Takhzyro), (EMEA-001864-PIP01-15-M07)

Reference Number: EMA/366000/2022