Olumiant is a medicine used in adults for treating:
• moderate to severe rheumatoid arthritis (a disease causing inflammation of the joints) when standard treatment with disease modifying anti rheumatic drugs (also known as ‘DMARDs’) has not worked well enough or if patients cannot tolerate them. Olumiant can be used either alone or in combination with the disease modifying drug methotrexate;
• moderate to severe atopic dermatitis (eczema) when treatments applied to the skin are not sufficient or appropriate.
• Severe alopecia areata (a disease causing hair loss of the scalp and/or other parts of the body).
Olumiant contains the active substance baricitinib.
Olumiant : EPAR - Medicine overview (PDF/107.03 KB)
First published: 16/03/2017
Last updated: 29/06/2022
Olumiant : EPAR - Risk-management-plan summary (PDF/342.86 KB)
First published: 27/10/2020
Last updated: 29/06/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Eli Lilly Nederland B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
20/06/2022 Olumiant - EMEA/H/C/004085 - II/0029/G
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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. Olumiant may be used as monotherapy or in combination with methotrexate.
Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 202216/12/2022
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen29/04/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 202018/09/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 201616/12/2016