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

biocon pharma inc. - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: - patients with severe hepatic impairment [see warnings and precautions (5.1) ]. - pregnant women and females of reproductive potential not using effective contraception. teriflunomide tablet may cause fetal harm [see warnings and precautions (5.2, 5.3) and use in specific populations (8.1) ]. - patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablet. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions (5.5)]. - coadministration with leflunomide [see clinical pharmacology (12.3)]. risk summary teriflunomide is contraindicated for use in pregnant women and females of reproductive potential

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

glenmark pharmaceuticals inc., usa - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: risk summary teriflunomide is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data [see contraindications (4) and warnings and precautions (5.2)]. in animal reproduction studies in rat and rabbit, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (auc) lower than that at the maximum recommended human dose (mrhd) of 14 mg/day [see data] . available human data from pregnancy registries, clinical trials, pharmacovigilance cases, and published literature are too limited to draw any conclusions, but they do not clearly indicate increased birth defects or m

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

breckenridge pharmaceutical, inc. - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: - patients with severe hepatic impairment [see warnings and precautions (5.1)] . - pregnant women and females of reproductive potential not using effective contraception. teriflunomide may cause fetal harm [see warnings and precautions (5.2, 5.3) and use in specific populations (8.1)] . - patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablets. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions (5.5)] . - co-administration with leflunomide [see clinical pharmacology (12.3)] . risk summary teriflunomide is contraindicated for use in pregnant women and females of reproductive potential not using

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

alembic pharmaceuticals limited - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablets  are indicated for the treatment of patients with relapsing forms of multiple sclerosis.  teriflunomide tablet is contraindicated in/with: ·         patients with severe hepatic impairment [see warnings and precautions (5.1)] . ·         pregnant women and females of reproductive potential not using effective contraception. teriflunomide tablet may cause fetal harm [see warnings and precautions (5.2, and 5.3) and use in specific populations (8.1)] . ·         patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablet. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions (5.5)]. ·         coadministration with leflunomide [see clinical pharmacology (12.3)]. risk summary teriflunomide tablets are contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm ba

Canada - English - Health Canada

teva canada limited - teriflunomide - tablet - 14mg - teriflunomide 14mg

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

apotex corp - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: - patients with severe hepatic impairment [see warnings and precautions (5.1)] . - pregnant women and females of reproductive potential not using effective contraception. teriflunomide tablets may cause fetal harm [see warnings and precautions (5.2, 5.3) and use in specific populations (8.1)] . - patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablets. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions (5.5)]. - coadministration with leflunomide [see clinical pharmacology (12.3)]. risk summary teriflunomide tablets are contraindicated for use in pregnant women and females of reproduct

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

glenmark pharmaceuticals inc., usa - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: risk summary teriflunomide is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data [see contraindications (4) and warnings and precautions (5.2)]. in animal reproduction studies in rat and rabbit, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (auc) lower than that at the maximum recommended human dose (mrhd) of 14 mg/day [see data] . available human data from pregnancy registries, clinical trials, pharmacovigilance cases, and published literature are too limited to draw any conclusions, but they do not clearly indicate increased birth defects or m

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

camber pharmaceuticals, inc. - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: • patients with severe hepatic impairment [see warnings and precautions ( 5.1)]. • pregnant women and females of reproductive potential not using effective contraception. teriflunomide may cause fetal harm [see warnings and precautions ( 5.2, 5.3) and use in specific populations ( 8.1)]. • patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablets. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions ( 5.5)]. • coadminist

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

dr reddys laboratories australia pty ltd - teriflunomide, quantity: 14 mg - tablet - excipient ingredients: maize starch; lactose monohydrate; sodium starch glycollate; hyprolose; silicon dioxide; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; indigo carmine aluminium lake - apo-teriflunomide is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

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

amneal pharmaceuticals of new york llc - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: - patients with severe hepatic impairment [see warnings and precautions (5.1)] . - pregnant women and females of reproductive potential not using effective contraception. teriflunomide tablets may cause fetal harm [see warnings and precautions (5.2, 5.3) and use in specific populations (8.1)]. - patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablets. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions (5.5)] . - co-administration with leflunomide [see clinical pharmacology (12.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women expos