Australia - English - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - bimekizumab, quantity: 160 mg/ml - injection - excipient ingredients: polysorbate 80; water for injections; glacial acetic acid; glycine; sodium acetate trihydrate - bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - bimekizumab, quantity: 160 mg/ml - injection - excipient ingredients: glacial acetic acid; polysorbate 80; sodium acetate trihydrate; glycine; water for injections - bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Israel - English - Ministry of Health

neopharm ltd, israel - bimekizumab - solution for injection - bimekizumab 160 mg / 1 ml - bimekizumab - bimzelx ® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

European Union - English - EMA (European Medicines Agency)

ucb pharma s.a.   - bimekizumab - psoriasis - immunosuppressants - plaque psoriasisbimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.psoriatic arthritisbimzelx, 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 spondyloarthritisnon-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.

Canada - English - Health Canada

ucb canada inc - bimekizumab - solution - 160mg - bimekizumab 160mg

Canada - English - Health Canada

ucb canada inc - bimekizumab - solution - 160mg - bimekizumab 160mg

United States - English - NLM (National Library of Medicine)

ucb, inc. - bimekizumab (unii: 09495uim6v) (bimekizumab - unii:09495uim6v) - bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to bimzelx during pregnancy. for more information, healthcare providers or patients can contact the organization of teratology information specialists (otis) autoimmune diseases study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. risk summary available data from case reports on bimzelx use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. transport of human igg antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, bimzelx may be transmitted from the mother to the developing fetus (see clinical considerations) . in an enhanced pre- and postnatal developm

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ucb pharma ltd - bimekizumab - solution for injection - 160mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ucb pharma ltd - bimekizumab - solution for injection - 160mg/1ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ucb pharma s.a., belgium - bimekizumab - solution for injection in pre-filled pen - 160 mg/ml