EMA/PE/0000236886 - paediatric investigation plan

baricitinib

Key facts

• Invented name:
  Olumiant
• Active substance:
  baricitinib
• Therapeutic area:
  Endocrine disorders
• Decision number:
  EMA/PE/0000236886
• PIP number:
  EMA/PE/0000236886
• Pharmaceutical form(s):
  • Age appropriate oral liquid dosage formulation
  • Tablet
• Condition(s) / indication(s):
  Prevention of stage 3 type 1 diabetes mellitus
• 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:
  10/09/2025
• Compliance check done:
  No

Decision

EMA/PE/0000236886 : EMA decision of 10 September 2025 on the agreement of a paediatric investigation plan and on the granting of a waiver for baricitinib (Olumiant)

Adopted Reference Number: EMADOC-1700519818-2406264