EMEA-001925-PIP02-19-M01 - paediatric investigation plan

Pegzilarginase

Key facts

• Active substance:
  Pegzilarginase
• Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Neurology
• Decision number:
  P/0483/2023
• PIP number:
  EMEA-001925-PIP02-19-M01
• Pharmaceutical form(s):
  • Solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of Hyperargininaemia
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/11/2023
• Compliance check done:
  Nej

Decision

P/0483/2023: EMA decision of 30 November 2023 on the acceptance of a modification of an agreed paediatric investigation plan for pegzilarginase (EMEA-001925-PIP02-19-M01)

Adopted Reference Number: EMA/494317/2023