EMEA-002827-PIP01-20-M03 - paediatric investigation plan

botaretigene sparoparvovec

Key facts

• Active substance:
  botaretigene sparoparvovec
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0269/2024
• PIP number:
  EMEA-002827-PIP01-20-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Retinitis Pigmentosa
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/07/2024
• Compliance check done:
  No

Decision

P/0269/2024: EMA decision of 17 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for botaretigene sparoparvovec (EMEA-002827-PIP01-20-M03)

Adopted Reference Number: EMA/328869/2024