EMEA-002796-PIP01-20-M02 - paediatric investigation plan

acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid) (IB1001)

Key facts

• Active substance:
  acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid) (IB1001)
• Therapeutic area:
  Neurology
• Decision number:
  P/0043/2024
• PIP number:
  EMEA-002796-PIP01-20-M02
• Pharmaceutical form(s):
  Age appropriate oral liquid dosage formulation
• 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:
  14/02/2024
• Compliance check done:
  No

Decision

P/0043/2024 : EMA decision of 14 February 2024 on the acceptance of a modification of an agreed paediatric investigation plan for acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid) (IB001) (EMEA-002796-PIP01-20-M02)

Adopted Reference Number: EMA/28207/2024