EMA/PE/0000244420 - paediatric investigation plan

vamorolone

Key facts

• Invented name:
  Agamree
• Active substance:
  vamorolone
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000244420
• PIP number:
  EMA/PE/0000244420
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  26/06/2025
• Compliance check done:
  Nei

Decision

EMA/PE/0000244420 : EMA decision of 26 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for vamorolone (Agamree)

Adopted Reference Number: EMADOC-1700519818-2238804