EMEA-001828-PIP01-15-M03 - paediatric investigation plan

pegunigalsidase alfa

Key facts

• Invented name:
  Elfabrio
• Active substance:
  pegunigalsidase alfa
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0290/2022
• PIP number:
  EMEA-001828-PIP01-15-M03
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Fabry disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2022
• Compliance check done:
  Nie

Decision

P/0290/2022: EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for pegunigalsidase alfa (EMEA-001828-PIP01-15-M03)

Reference Number: EMA/630274/2022