EMEA-002582-PIP02-21 - paediatric investigation plan

Remibrutinib

Key facts

• Active Substance:
  Remibrutinib
• Therapeutic area:
  Neurology
• Decision number:
  P/0345/2022
• PIP number:
  EMEA-002582-PIP02-21
• 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

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/08/2022

Decision

P/0345/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for remibrutinib (EMEA-002582-PIP02-21)

AdoptedReference Number: EMA/638352/2022