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

biogen australia pty ltd - natalizumab, quantity: 300 mg - injection, concentrated - excipient ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - tysabri (natalizumab) is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (ms) to delay the progression of physical disability and to reduce the frequency of relapse.

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

biogen inc. - natalizumab (unii: 3jb47n2q2p) (natalizumab - unii:3jb47n2q2p) - natalizumab 300 mg in 15 ml - tysabri is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. tysabri increases the risk of pml [see warnings and precautions (5.1) ]. when initiating and continuing treatment with tysabri, physicians should consider whether the expected benefit of tysabri is sufficient to offset this risk. tysabri is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional cd therapies and inhibitors of tnf-α. tysabri should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of tnf-α [see warnings and precautions (5.1) ]. - tysabri is contraindicated in patients who have or have had progressive mult

Israel - English - Ministry of Health

medison pharma ltd - natalizumab - concentrate for solution for infusion - natalizumab 300 mg / 15 ml - natalizumab - natalizumab - tysabri is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis . to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. the safety and efficacy of tysabri beyond two years are unknown. because tysabri increases the risk of progressive multifocal leukoencephalopathy (pml), an opportunistic viral infection of the brain that usually leads to death or severe disability. tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies. safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.

European Union - English - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - crohn disease - immunostimulants, - treatment of moderately to severely active crohn's disease for the reduction of signs and symptoms, and the induction and maintenance of sustained response and remission, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or are intolerant to or have medical contraindications to such therapies.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - satralizumab - solution for injection - satralizumab 120 mg / 1 ml - satralizumab - enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosuppressants - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

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

genentech inc. - satralizumab (unii: yb18nf020m) (satralizumab - unii:yb18nf020m) - enspryng is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. enspryng is contraindicated in patients with: - a known hypersensitivity to satralizumab or any of the inactive ingredients [see warnings and precautions (5.4)] - active hepatitis b infection [see warnings and precautions (5.1)] - active or untreated latent tuberculosis [see warnings and precautions (5.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to enspryng during pregnancy. healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-277-9338. risk summary there are no adequate data on the developmental risk associated with the use of enspryng in pregnant women. in an animal reproduction study, no adverse effects on maternal animals or fetal development were observed in pregnant monkeys and their offspring,

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

biogen australia pty ltd - natalizumab, quantity: 150 mg - injection, solution - excipient ingredients: sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate heptahydrate; polysorbate 80; water for injections - tysabri is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (ms) to delay the progression of physical disability and to reduce the frequency of relapse.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

roche (malaysia) sdn. bhd. - satralizumab -

European Union - English - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multiple sclerosis - selective immunosuppressants - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4.4 and 5.1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.