EMEA-003457-PIP01-23 - paediatric investigation plan

laruparetigene zovaparvovec

Key facts

• Active substance:
  laruparetigene zovaparvovec
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0159/2024
• PIP number:
  EMEA-003457-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of X-linked retinitis pigmentosa
• Route(s) of administration:
  Intraocular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/05/2024
• Compliance check done:
  No

Decision

P/0159/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for laruparetigene zovaparvovec (EMEA-003457-PIP01-23)

Adopted Reference Number: EMA/170634/2024