Olumiant
baricitinib
Table of contents
Overview
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.
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List item
Olumiant : EPAR - Medicine overview (PDF/107.03 KB)
First published: 16/03/2017
Last updated: 29/06/2022
EMA/573492/2022 -
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List item
Olumiant : EPAR - Risk-management-plan summary (PDF/342.86 KB)
First published: 27/10/2020
Last updated: 29/06/2022
Authorisation details
Product details | |
---|---|
Name |
Olumiant
|
Agency product number |
EMEA/H/C/004085
|
Active substance |
baricitinib
|
International non-proprietary name (INN) or common name |
baricitinib
|
Therapeutic area (MeSH) |
Arthritis, Rheumatoid
|
Anatomical therapeutic chemical (ATC) code |
L04AA37
|
Publication details | |
---|---|
Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
10
|
Date of issue of marketing authorisation valid throughout the European Union |
13/02/2017
|
Contact address |
Papendorpseweg 83 |
Product information
20/06/2022 Olumiant - EMEA/H/C/004085 - II/0029/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic 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. Olumiant may be used as monotherapy or in combination with methotrexate.
Atopic Dermatitis
Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Alopecia areata
Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1).