Medicinal product (solution for injection in a pre-filled syringe) for treatment of the skin disease plaque psoriasis in adults
Public Summary SwissPAR dated 03.02.2023
Bimzelx® (active substance: bimekizumab)
First authorisation in Switzerland: 27 October 2022
Information on authorisation
The medicinal product Bimzelx, which contains the active substance bimekizumab, is a solution for injection in a pre-filled syringe.
Bimzelx is used in adults for the treatment of plaque psoriasis, a skin disease whose symptoms include pain, itching and scaly patches of skin. Bimzelx relieves these and other symptoms of the disease.
In deciding whether to authorise the medicinal product Bimzelx, containing the active substance bimekizumab, Swissmedic took into account the assessment of the European Medicines Agency (EMA) regarding certain aspects such as the clinical data, as well as the corresponding product information.
Since the assessment of the clinical data was based on the assessment report of a foreign authority, the preconditions for a SwissPAR (Swiss Public Assessment Report) and a resulting Public Summary SwissPAR are not fully met. Swissmedic refers to the authorisation by the foreign reference authority.
Further information on the medicinal product
Information for healthcare professionals:
Information for patients:
Healthcare professionals can answer any further questions.
Bimzelx® (active substance: bimekizumab) (PDF, 160 kB, 03.02.2023)Prima omologazione
The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Public Summary SwissPAR.
Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals.
New findings that could impair the quality, efficacy or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.