EMEA-000798-PIP01-09-M03 - paediatric investigation plan

ponesimod

Key facts

• Active Substance:
  ponesimod
• Therapeutic area:
  • Neurology
  • Other
• Decision number:
  P/0066/2021
• PIP number:
  EMEA-000798-PIP01-09-M03
• 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

  Tel. + 32 1460 2111; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/02/2021

Decision

P/0066/2021 : EMA decision of 18 February 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ponesimod (EMEA- 000798-PIP01-09-M03)

AdoptedReference Number: EMA/79020/2021