EMEA-002888-PIP01-20 - paediatric investigation plan

alpha1-proteinase inhibitor (human)

Key facts

• Active substance:
  alpha1-proteinase inhibitor (human)
• Therapeutic area:
  • Haematology-Hemostaseology
  • Pneumology-allergology
• Decision number:
  P/0035/2021
• PIP number:
  EMEA-002888-PIP01-20
• Pharmaceutical form(s):
  Powder and solvent for solution for infusion
• Condition(s) / indication(s):
  Treatment of emphysema secondary to alpha 1-proteinase inhibitor deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2021
• Compliance check done:
  No

Decision

P/0035/2021 : EMA decision of 27 January 2021 on the granting of a product specific waiver for alpha1-Proteinase Inhibitor (Human), (EMEA-002888-PIP01-20)

Adopted Reference Number: EMA/27140/2021