EMEA-001794-PIP02-16-M09 - paediatric investigation plan

vamorolone

Key facts

• Invented name:
  Agamree
• Active substance:
  vamorolone
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0355/2024
• PIP number:
  EMEA-001794-PIP02-16-M09
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0355/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vamorolone (Agamree), (EMEA-001794-PIP02-16-M09)

Adopted Reference Number: EMA/444192/2024