EMEA-002397-PIP01-18-M03 - paediatric investigation plan

Ofatumumab

Key facts

• Invented name:
  Kesimpta
• Active Substance:
  Ofatumumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0537/2022
• PIP number:
  EMEA-002397-PIP01-18-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novartis Ireland Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022

Decision

P/0537/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ofatumumab (Kesimpta) (EMEA-002397-PIP01-18-M03)

AdoptedReference Number: EMA/901114/2022