🇪🇺 Baricitinib 4 MG in European Union

EMA authorised Baricitinib 4 MG on 13 February 2017

Marketing authorisation

EMA — authorised 13 February 2017

  • Application: EMEA/H/C/004085
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Olumiant
  • Indication: Rheumatoid arthritis Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe al
  • Status: approved

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Baricitinib 4 MG in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Baricitinib 4 MG approved in European Union?

Yes. EMA authorised it on 13 February 2017.

Who is the marketing authorisation holder for Baricitinib 4 MG in European Union?

Eli Lilly Nederland B.V. holds the EU marketing authorisation.