EMA/PE/0000224175 - paediatric investigation plan

azamidugene autotemcel (OTL-203)

Key facts

• Active substance:
  azamidugene autotemcel (OTL-203)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000224175
• PIP number:
  EMA/PE/0000224175
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of mucopolysaccharidosis type I, Hurler syndrome
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000224175 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for azamidugene autotemcel

Adopted Reference Number: EMADOC-1700519818-1855254 Corr1