EMEA-001864-PIP02-19 - paediatric investigation plan

lanadelumab

Key facts

• Invented name:
  Takhzyro
• Active substance:
  lanadelumab
• Therapeutic area:
  Other
• Decision number:
  P/0140/2020
• PIP number:
  EMEA-001864-PIP02-19
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of acquired angioedema attacks
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/04/2020
• Compliance check done:
  Ei

Decision

P/0140/2020: EMA decision of 18 April 2020 on the granting of a product specific waiver for lanadelumab (Takhzyro) (EMEA-001864-PIP02-19)

Adopted Reference Number: EMA/174092/2020