EMEA-001312-PIP02-19 - paediatric investigation plan

alpha1-proteinase inhibitor (human)

Key facts

• Active substance:
  alpha1-proteinase inhibitor (human)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0134/2020
• PIP number:
  EMEA-001312-PIP02-19
• Pharmaceutical form(s):
  • Powder and solvent for solution for injection
  • Powder and solvent for solution for infusion
• Condition(s) / indication(s):
  Prevention of graft versus host disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/04/2020
• Compliance check done:
  No

Decision

P/0134/2020: EMA decision of 15 April 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for alpha1-proteinase inhibitor (human) (A1-PI) (EMEA-001312-PIP02-19)

Adopted Reference Number: EMA/132888/2020