EMA/PE/0000247846 - paediatric investigation plan

arimoclomol citrate

Key facts

• Active substance:
  arimoclomol citrate
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000247846
• PIP number:
  EMA/PE/0000247846
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of Niemann-Pick disease, type C
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/06/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000247846 : EMA decision of 12 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for arimoclomol (citrate)

Adopted Reference Number: EMADOC-1700519818-2191054