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

southern cross pharma pty ltd - leflunomide, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; crospovidone; magnesium stearate; lactose monohydrate; maize starch; titanium dioxide; hypromellose; macrogol 4000 - treatment of active rheumatoid arthritis. the combined use of leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).

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

southern cross pharma pty ltd - leflunomide, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; maize starch; povidone; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000 - treatment of active rheumatoid arthritis. the combined use of leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).

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

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

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

kvk-tech, inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (ra). leflunomide tablets are contraindicated in: - pregnant women. leflunomide tablets may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1 )]. patients with severe hepatic impairment [see warnings and precautions (5.2) ]. - patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. known reactions include anaphylaxis [see adverse reactions (6.1) ]. - patients being treated with teriflunomide [see drug interactions (7) ]. risk summary leflunomide tablets are contraindicated for use in pregnant women because of the potential for fetal harm. in animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of

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

lupin pharmaceuticals, inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide tablets usp are indicated for the treatment of adults with active rheumatoid arthritis (ra). leflunomide tablet is contraindicated in: - pregnant women. leflunomide tablets may cause fetal harm.  if a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)]. - patients with severe hepatic impairment [see warnings and precautions (5.2)]. - patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. known reactions include anaphylaxis [see adverse reactions (6.1)]. - patients being treated with teriflunomide [see drug interactions (7)]. risk summary leflunomide tablet is contraindicated for use in pregnant women because of the potential for fetal harm.  in animal reproduction studies, oral administration of leflunomi

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

aurobindo pharma limited - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (ra). leflunomide tablets are contraindicated in: - pregnant women. leflunomide tablets  may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)]. - patients with severe hepatic impairment [see warnings and precautions (5.2)]. - patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. known reactions include anaphylaxis [see adverse reactions (6.1)]. - patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pregnancies by calli

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare limited - leflunomide - tablet - 10 milligram(s) - selective immunosuppressants; leflunomide

Ireland - English - HPRA (Health Products Regulatory Authority)

aspire pharma limited - leflunomide - film-coated tablet - 20 milligram(s) - selective immunosuppressants; leflunomide

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare limited - leflunomide - tablet - 20 milligram(s) - selective immunosuppressants; leflunomide

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare limited - leflunomide - tablet - 100 milligram(s) - selective immunosuppressants; leflunomide