EMA/PE/0000245980 - paediatric investigation plan

sepofarsen

Key facts

• Active substance:
  sepofarsen
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000245980
• PIP number:
  EMA/PE/0000245980
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Leber's Congenital Amaurosis
• Route(s) of administration:
  Intravitreal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000245980 : EMA decision of 12 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for sepofarsen

Adopted Reference Number: EMADOC-1700519818-2189975