EMEA-003570-PIP01-23 - paediatric investigation plan

human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant

Key facts

• Active Substance:
  human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0156/2024
• PIP number:
  EMEA-003570-PIP01-23
• 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:
  06/05/2024

Decision

P/0156/2024: EMA decision of 6 May 2024 on the granting of a product-specific waiver for human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant (EMEA-003570-PIP01-23)

Reference Number: EMA/148133/2024