Jyseleca

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filgotinib

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

Overview

Jyseleca is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease in which the immune system (the body’s natural defences) attacks healthy tissue to cause inflammation and pain in joints.

Jyseleca is used alone or with another medicine, methotrexate, after treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or causes unacceptable side effects. DMARDs are medicines, such as methotrexate, that slow down worsening of the disease.

Jyseleca contains the active substance filgotinib.

This EPAR was last updated on 28/09/2020

Authorisation details

Product details
Name
Jyseleca
Agency product number
EMEA/H/C/005113
Active substance
filgotinib maleate
International non-proprietary name (INN) or common name
filgotinib
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA
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
Gilead Sciences Ireland UC
Date of issue of marketing authorisation valid throughout the European Union
24/09/2020
Contact address

Carrigtohill
County Cork T45 DP77
Ireland

Product information

24/09/2020 Jyseleca - EMEA/H/C/005113 -

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Jyseleca 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 (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).

Assessment history

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