EMEA-001951-PIP01-16-M03 - paediatric investigation plan

pegvaliase

Key facts

• Invented name:
  Palynziq
• Active substance:
  pegvaliase
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0241/2024
• PIP number:
  EMEA-001951-PIP01-16-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hyperphenylalaninaemia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2024
• Compliance check done:
  No

Decision

P/0241/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for pegvaliase (Palynziq), (EMEA-001951-PIP01-16-M03)

Adopted Reference Number: EMA/298061/2024