Singapore - English - HSA (Health Sciences Authority)

eisai (singapore) pte. ltd. - natalizumab - infusion, solution concentrate - 300 mg/15ml - natalizumab 300 mg/15ml

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

biogen idec ltd - natalizumab - solution for infusion - 20mg/1ml

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)

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.

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

biogen idec b.v-natherland, netherlands - natalizumab - solution for injection in pre-filled syringe - 150 mg

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressants - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease 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 rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.,