EMEA-001864-PIP03-19-M01 - paediatric investigation plan

lanadelumab

Key facts

• Invented name:
  Takhzyro
• Active substance:
  lanadelumab
• Therapeutic area:
  Other
• Decision number:
  P/0037/2023
• PIP number:
  EMEA-001864-PIP03-19-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of attacks of Idiopathic non-histaminergic angioedema (INHA)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2020
• Compliance check done:
  Nee

Decision

P/0037/2023: EMA decision of 31 January 2023 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a product-specific waiver for lanadelumab (Takhzyro), (EMEA-001864-PIP03-19-M01)

Adopted Reference Number: EMA/21184/2023