EMEA-000716-PIP01-09-M05 - paediatric investigation plan

Siponimod (hemifumarate)

Key facts

• Invented name:
  Mayzent
• Active Substance:
  Siponimod (hemifumarate)
• Therapeutic area:
  Neurology
• Decision number:
  P/0531/2022
• PIP number:
  EMEA-000716-PIP01-09-M05
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

  United Kingdom; 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/0531/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for siponimod (hemifumarate) (Mayzent), (EMEA-000716-PIP01-09-M05)

AdoptedReference Number: EMA/929763/2022