EMEA-002435-PIP01-18-M03 - paediatric investigation plan

Eladocagene exuparvovec

Key facts

• Invented name:
  Upstaza
• Active substance:
  Eladocagene exuparvovec
• Therapeutic area:
  Neurology
• Decision number:
  P/0075/2023
• PIP number:
  EMEA-002435-PIP01-18-M03
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of aromatic L-amino acid decarboxylase deficiency
• Route(s) of administration:
  Intraputaminal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-002435-PIP01-18-M03
• Compliance opinion date:
  26/05/2023
• Compliance outcome:
  Positive

Decision

P/0075/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for eladocagene exuparvovec (Upstaza), (EMEA-002435-PIP01-18-M03)

Reference Number: EMA/84338/2023