EMEA-001220-PIP05-19 - paediatric investigation plan

Baricitinib

Key facts

• Invented name:
  Olumiant
• Active Substance:
  Baricitinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0070/2020
• PIP number:
  EMEA-001220-PIP05-19
• Pharmaceutical form(s):
  • Tablet
  • Age-appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• 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:
  18/03/2020

Decision

P/0070/2020: EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for baricitinib (Olumiant) (EMEA-001220-PIP05-19)

AdoptedReference Number: EMA/83628/2020