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

abbvie - daclizumab (unii: cuj2mvi71y) (daclizumab - unii:cuj2mvi71y) - daclizumab 150 mg in 1 ml - zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (ms). because of its safety profile, the use of zinbryta should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of ms. zinbryta is contraindicated in patients with: - pre-existing hepatic disease or hepatic impairment, including alt or ast at least 2 times the uln, because zinbryta could exacerbate existing liver dysfunction [see dosage and administration (2.3) and warnings and precautions (5.1)] . - a history of autoimmune hepatitis or other autoimmune condition involving the liver [see warnings and precautions (5.1)]. - a history of hypersensitivity to daclizumab or any other components of the formulation. use in such patients may result in anaphylaxis or life-threatening multi-organ hypersensitivity [see warnings and precautions (5.4)] . risk summary there are no adequate data on the developmental risk associated with use of zinbryta in

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

biogen australia pty ltd - daclizumab -

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

biogen australia pty ltd - daclizumab -

European Union - English - EMA (European Medicines Agency)

roche registration ltd. - daclizumab - graft rejection; kidney transplantation - immunosuppressants - zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.

European Union - English - EMA (European Medicines Agency)

biogen idec ltd - daclizumab - multiple sclerosis - immunosuppressants - zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (rms).

Canada - English - Health Canada

hoffmann-la roche limited - daclizumab - liquid - 5mg - daclizumab 5mg - immunosuppressive agents

Canada - English - Health Canada

biogen canada inc - daclizumab beta - solution - 150mg - daclizumab beta 150mg - immunomodulatory agents

Canada - English - Health Canada

biogen canada inc - daclizumab beta - solution - 150mg - daclizumab beta 150mg - immunomodulatory agents

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - daclizumab 5 mg/ml (murine/human);   - concentrate for infusion - 5 mg/ml - active: daclizumab 5 mg/ml (murine/human)   excipient: dibasic sodium phosphate heptahydrate hydrochloric acid monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride sodium hydroxide water for injection

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

roche products ltd - daclizumab - solution for infusion - 5mg/1ml