🇪🇺 YUFLYMA in European Union

EMA authorised YUFLYMA on 11 February 2021

Marketing authorisation

Application: EMEA/H/C/005188
Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
Local brand name: Yuflyma
Indication: Rheumatoid arthritis Yuflyma in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint
Pathway: biosimilar
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is YUFLYMA approved in European Union?

Yes. EMA authorised it on 11 February 2021.

Who is the marketing authorisation holder for YUFLYMA in European Union?

Celltrion Healthcare Hungary Kft. holds the EU marketing authorisation.