🇪🇺 BIMZELX in European Union

EMA authorised BIMZELX on 20 August 2021

Marketing authorisation

EMA — authorised 20 August 2021

  • Application: EMEA/H/C/005316
  • Marketing authorisation holder: UCB Pharma S.A.
  • Local brand name: Bimzelx
  • Indication: Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with o
  • Status: approved

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BIMZELX 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 BIMZELX approved in European Union?

Yes. EMA authorised it on 20 August 2021.

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

UCB Pharma S.A. holds the EU marketing authorisation.