Olumiant

RSS

baricitinib

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

Overview

Olumiant is a medicine used for treating rheumatoid arthritis (a disease causing inflammation of the joints).

It is used in patients with moderate to severe arthritis 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 DMARD methotrexate.

Olumiant contains the active substance baricitinib.

This EPAR was last updated on 18/12/2018

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
5
Date of issue of marketing authorisation valid throughout the European Union
13/02/2017
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

04/09/2018 Olumiant - EMEA/H/C/004085 - II/0006

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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.

Assessment history

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