EMEA-002284-PIP01-17 - paediatric investigation plan

Evobrutinib

Key facts

• Active substance:
  Evobrutinib
• Therapeutic area:
  Neurology
• Decision number:
  P/0393/2018
• PIP number:
  EMEA-002284-PIP01-17
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/12/2012
• Compliance check done:
  No

Decision

P/0393/2018: EMA decision of 6 December 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for evobrutinib (EMEA-002284-PIP01-17)

Adopted Reference Number: EMA/775595/2018