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

sanofi-aventis u.s. llc - sarilumab (unii: nu90v55f8i) (sarilumab - unii:nu90v55f8i) - sarilumab 150 mg in 1.14 ml - kevzara® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (dmards). kevzara is indicated for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. kevzara is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients [see warnings and precautions (5.5) and adverse reactions (6.1)] . risk summary the limited human data with kevzara in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. monoclonal antibodies, such as sarilumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations) . from animal data, and consistent with the mechanism of ac

Israel - English - Ministry of Health

sanofi israel ltd - sarilumab - solution for injection - sarilumab 131.6 mg / 1 ml - sarilumab - kevzara in combination with methotrexate (mtx) is indicated for the treatment of moderately to severely active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). kevzara can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate.

Israel - English - Ministry of Health

sanofi israel ltd - sarilumab - solution for injection - sarilumab 175 mg / 1 ml - sarilumab - kevzara in combination with methotrexate (mtx) is indicated for the treatment of moderately to severely active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). kevzara can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate.kevzara is indicated for treatment of adult patients with polymyalgia rheumatica who cannot tolerate corticosteroid taper

European Union - English - EMA (European Medicines Agency)

sanofi winthrop industrie - sarilumab - arthritis, rheumatoid - immunosuppressants - kevzara in combination with methotrexate (mtx) is indicated for the treatment of moderately to severely active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). kevzara can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate.

Canada - English - Health Canada

sanofi-aventis canada inc - sarilumab - solution - 200mg - sarilumab 200mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

sanofi-aventis canada inc - sarilumab - solution - 150mg - sarilumab 150mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

sanofi-aventis canada inc - sarilumab - solution - 200mg - sarilumab 200mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

sanofi-aventis canada inc - sarilumab - solution - 150mg - sarilumab 150mg - disease-modifying antirheumatic agents

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

sanofi - sarilumab - solution for injection - 131.6mg/1ml

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

sanofi - sarilumab - solution for injection - 175mg/1ml