This medicine is authorised for use in the European Union.


Bimzelx is a medicine used to treat the following inflammatory diseases:

  • moderate-to-severe plaque psoriasis (red, scaly patches on the skin) in adults who need systemic treatment (treatment with medicines affecting the whole body).
  • psoriatic arthritis (inflammation of the joints that often accompanies plaque psoriasis) in adults whose disease does not respond well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot take these medicines. For psoriatic arthritis, Bimzelx is used alone or with
  • axial spondyloarthritis (inflammation of the spine causing back pain) in adults whose disease does not respond well enough to conventional treatments. For this condition, it is used in patients who have signs of disease on X-rays (radiographic axial spondyloarthritis) as well as in patients who have clear signs of inflammation but no signs of disease on X-rays (non-radiographic axial spondyloarthritis).

 Bimzelx contains the active substance bimekizumab.

This EPAR was last updated on 13/11/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
UCB Pharma S.A.  
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Allée de la Recherche 60
B-1070 Bruxelles

Product information

09/11/2023 Bimzelx - EMEA/H/C/005316 - IB/0022

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic 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 objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Assessment history

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