EMEA-003463-PIP01-23 - paediatric investigation plan

human alpha-1 proteinase inhibitor, modified (SerpinPC)

Key facts

• Active substance:
  human alpha-1 proteinase inhibitor, modified (SerpinPC)
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0215/2024
• PIP number:
  EMEA-003463-PIP01-23
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of Haemophilia B
• 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:
  13/06/2024
• Compliance check done:
  No

Decision

P/0215/2024 : EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human alpha-1 proteinase inhibitor, modified (SerpinPC) (EMEA-003463- PIP01-23)

Adopted Reference Number: EMA/255061/2024