🇪🇺 HYRIMOZ in European Union

EMA authorised HYRIMOZ on 26 July 2018

Marketing authorisation

Application: EMEA/H/C/004320
Marketing authorisation holder: Sandoz GmbH
Local brand name: Hyrimoz
Indication: Rheumatoid arthritis Hyrimoz 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. Hyrimoz 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 progress
Pathway: biosimilar
Status: approved

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

Is HYRIMOZ approved in European Union?

Yes. EMA authorised it on 26 July 2018.

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

Sandoz GmbH holds the EU marketing authorisation.