New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - leflunomide 20mg - tablet - 20 mg - active: leflunomide 20mg excipient: colloidal silicon dioxide crospovidone lactose magnesium stearate - apo-leflunomide is indicated for the treatment of: · rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. · active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - leflunomide - arthritis, rheumatoid - immunosuppressants - leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - leflunomide - arthritis, rheumatoid - selective immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

European Union - English - EMA (European Medicines Agency)

ratiopharm gmbh - leflunomide - arthritis, rheumatoid - immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard);active psoriatic arthritis.recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard);active psoriatic arthritis.recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

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

sanofi-aventis australia pty ltd - leflunomide -

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

sanofi-aventis australia pty ltd - leflunomide -

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

medis pharma pty ltd - leflunomide, quantity: 100 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; maize starch; povidone; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 4000 - treatment of active rheumatoid arthritis.,treatment of active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. the combined use of leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).

Canada - English - Health Canada

apotex inc - leflunomide - tablet - 10mg - leflunomide 10mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

apotex inc - leflunomide - tablet - 20mg - leflunomide 20mg - disease-modifying antirheumatic agents