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.

Olumiant contains the active substance baricitinib.

This EPAR was last updated on 27/10/2020

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 monitoringAdditional 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
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
13/02/2017
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

19/10/2020 Olumiant - EMEA/H/C/004085 - II/0016

Contents

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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.

Assessment history

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