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.
Olumiant contains the active substance baricitinib.
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List item
Olumiant : EPAR - Medicine overview (PDF/146.05 KB)
First published: 16/03/2017
Last updated: 23/11/2018
EMA/505843/2020 -
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List item
Olumiant : EPAR - Risk-management-plan summary (PDF/196.45 KB)
First published: 27/10/2020
Last updated: 15/12/2020
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
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
13/02/2017
|
Contact address |
Product information
20/11/2020 Olumiant - EMEA/H/C/004085 - PSUSA/00010578/202002
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Rheumatoid Arthritis
Olumiant 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
Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.