🇪🇺 IDACIO in European Union

EMA authorised IDACIO on 2 April 2019

Marketing authorisation

Application: EMEA/H/C/004475
Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
Local brand name: Idacio
Indication: Rheumatoid arthritis Idacio 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. Idacio 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 dam
Pathway: biosimilar
Status: approved

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

Is IDACIO approved in European Union?

Yes. EMA authorised it on 2 April 2019.

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

Fresenius Kabi Deutschland GmbH holds the EU marketing authorisation.