EMA/PE/0000224955 - paediatric investigation plan

ribitol

Key facts

• Active substance:
  ribitol
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000224955
• PIP number:
  EMA/PE/0000224955
• Pharmaceutical form(s):
  • Powder for oral use
  • Age appropriate oral dosage formulation
• Condition(s) / indication(s):
  Treatment of limb-girdle muscular dystrophy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000224955 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ribitol

Adopted Reference Number: EMADOC-1700519818-1802285