EMEA-001525-PIP02-21 - paediatric investigation plan

human alpha1-proteinase inhibitor

Key facts

• Active substance:
  human alpha1-proteinase inhibitor
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0499/2021
• PIP number:
  EMEA-001525-PIP02-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/12/2021
• Compliance check done:
  No

Decision

P/0499/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for human alpha1-proteinase inhibitor (EMEA-001525-PIP02-21)

Adopted Reference Number: EMA/616526/2021