EMEA-003355-PIP01-22 - paediatric investigation plan

fazirsiran

Key facts

• Active Substance:
  fazirsiran
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0422/2023
• PIP number:
  EMEA-003355-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of congenital alpha-1 antitrypsin deficiency
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Takeda Pharma A/S

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/10/2023

Decision

P/0422/2023 : EMA decision of 27 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fazirsiran (EMEA-003355-PIP01-22)

AdoptedReference Number: EMA/429563/2023