EMA — authorised 24 September 2020
- Marketing authorisation holder: Gilead Sciences Ireland UC
- Status: approved
🇪🇺 Jyseleca in European Union
EMA authorised Jyseleca on 24 September 2020
Marketing authorisations
EMA — authorised 24 September 2020
- Application: EMEA/H/C/005113
- Marketing authorisation holder: Alfasigma S.p.A.
- Local brand name: Jyseleca
- Indication: Rheumatoid arthritis 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). Ulcerative colitis Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
- Status: approved
Jyseleca in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in European Union
Frequently asked questions
Is Jyseleca approved in European Union?
Yes. EMA authorised it on 24 September 2020; EMA authorised it on 24 September 2020.
Who is the marketing authorisation holder for Jyseleca in European Union?
Gilead Sciences Ireland UC holds the EU marketing authorisation.