EMEA-002349-PIP03-20 - paediatric investigation plan

Fenebrutinib

Key facts

• Active substance:
  Fenebrutinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0319/2021
• PIP number:
  EMEA-002349-PIP03-20
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Tablet
• 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:
  13/08/2021
• Compliance check done:
  No

Decision

P/0319/2021 : EMA decision of 13 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fenebrutinib (EMEA-002349-PIP03-20)

Adopted Reference Number: EMA/385463/2021