New Zealand - English - Medsafe (Medicines Safety Authority)

celltrion healthcare new zealand limited - infliximab 120 mg/ml - solution for injection - 120 mg/ml - active: infliximab 120 mg/ml excipient: acetic acid polysorbate 80 sodium acetate trihydrate sorbitol water for injection - rheumatoid arthritis remsima sc, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: o adult patients with active disease when the response to disease-modifying antirheumatic drugs (dmards), including methotrexate, has been inadequate. o adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards. in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x-ray, has been demonstrated (see section 5.1).

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

celltrion inc. - infliximab - infliximab....100 mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

ethnor del istmo, s.a. - infliximab - infliximab....100.00 mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

pfizer japan inc. - infliximab - infliximab....100 mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

celltrion healthcare co. ltd. - infliximab - infliximab....100 mg

Namibia - English - Namibia Medicines Regulatory Council

janssen pharmaceutica (pty) ltd - infliximab, - injection - infliximab, dry injection, 100mg for 10ml

New Zealand - English - Medsafe (Medicines Safety Authority)

celltrion healthcare new zealand limited - infliximab 100mg;   - powder for injection - 100 mg - active: infliximab 100mg   excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate monohydrate polysorbate 80 sucrose - rheumatoid arthritis remsima is a ?disease-controlling anti-rheumatic therapy" (dcart) indicated for: · the reduction of signs and symptoms · prevention of structural joint damage (erosions and joint space narrowing) · improvement in physical function in patients with active disease. remsima should be given in combination with methotrexate

Israel - English - Ministry of Health

j-c health care ltd - infliximab 100 mg/vial - powder for concentrate for infusion - infliximab - - adult :crohn's disease: treatment of severe active crohn's disease in patients who have not responded despite of a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant. treatment of fistulising crohn's disease in patients who have not responded despite of a full and adequate course of therapy with conventional treatment. -paediatric crohn's disease: remicade is indicated for: treatment of severe active crohn's disease in paediatric patients aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid an immunomodulator and primary nutrition therapy or who are intolerant to or have contraindications for such therapies. remicade has been studied only in combination with conventional immunosuppressive therapy -ankylosing spondylitis: remicade is indicated for: treatment of ankylosing spondylitis in patients who have severe axial symptoms elevated serological markers of inflammatory activity and who have responded inadequately to conventional ther

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: celltrion healthcare philippines, inc.; distributor: celltrion healthcare philippines, inc. - infliximab - lyophilized powder for concentrate for solution for infusion (iv) - 100mg

Philippines - English - FDA (Food And Drug Administration)

zuellig pharma corporation - infliximab - powder for concentrate for solution for infusion - 100mg