Olumiant

RSS

baricitinib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 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
3528 BJ Utrecht
Netherlands

Product information

20/06/2022 Olumiant - EMEA/H/C/004085 - II/0029/G

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Product information documents contain:

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).

Assessment history

Changes since initial authorisation of medicine

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