EMEA-000798-PIP01-09-M04 - paediatric investigation plan

ponesimod

Key facts

• Invented name:
  Ponvory
• Active Substance:
  ponesimod
• Therapeutic area:
  • Neurology
  • Other
• Decision number:
  P/0234/2023
• PIP number:
  EMEA-000798-PIP01-09-M04
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen-Cilag International NV; E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0234/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ponesimod (Ponvory), (EMEA-000798-PIP01-09-M04)

Reference Number: EMA/235934/2023