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
Contact for public enquiries

Eli Lilly & Company Limited

Tel. +44 (0)1276 483000
E-mail: eu_paediatric@lilly.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

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)

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