EMEA-001220-PIP07-20-M01 - paediatric investigation plan

Baricitinib

Key facts

• Invented name:
  Olumiant
• Active Substance:
  Baricitinib
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0364/2022
• PIP number:
  EMEA-001220-PIP07-20-M01
• Pharmaceutical form(s):
  • Age-appropriate oral liquid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0364/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant), (EMEA-001220-PIP07-20-M01)

AdoptedReference Number: EMA/697754/2022

Baricitinib (Olumiant) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision