EMEA-001794-PIP02-16-M05 - paediatric investigation plan

Vamorolone

Key facts

• Active Substance:
  Vamorolone
• Therapeutic area:
  Other
• Decision number:
  P/0295/2022
• PIP number:
  EMEA-001794-PIP02-16-M05
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  ReveraGen BioPharma Ltd

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2022

Decision

P/0295/2022: EMA decision on the acceptance of a modification of an agreed paediatric investigation plan for vamorolone (EMEA- 001794-PIP02-16-M05)

Reference Number: EMA/631111/2022