EMEA-003510-PIP01-23 - paediatric investigation plan

recombinant humanized IgG1, kappa light chain, long-acting monoclonal antibody (STAR-0215)

Key facts

• Active substance:
  recombinant humanized IgG1, kappa light chain, long-acting monoclonal antibody (STAR-0215)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0316/2024
• PIP number:
  EMEA-003510-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of hereditary angioedema attacks
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0316/2024 : EMA decision of 13 September 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant humanized IgG1, kappa light chain.....(EMEA-003510-PIP01-23)

Adopted Reference Number: EMA/410959/2024