EMEA-001220-PIP03-16-M02 - paediatric investigation plan

Baricitinib

Key facts

• Invented name:
  Olumiant
• Active Substance:
  Baricitinib
• Therapeutic area:
  Dermatology
• Decision number:
  P/0311/2021
• PIP number:
  EMEA-001220-PIP03-16-M02
• Pharmaceutical form(s):
  • Oral suspension
  • Tablet
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2021
• Compliance procedure number:
  EMEA-C-001220-PIP03-16-M02
• Compliance opinion date:
  11/11/2022
• Compliance outcome:
  Positive

Decision

P/0311/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant) (EMEA-001220-PIP03-16-M02)

AdoptedReference Number: EMA/427610/2021