Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

crescent pharma ltd - topiramate - oral tablet - 25mg

Estados Unidos - inglés - NLM (National Library of Medicine)

zydus lifesciences limited - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated as adjunctive therapy for  for the treatment of partial-onset seizures,  primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-f

Canadá - inglés - Health Canada

dominion pharmacal - topiramate - tablet - 25mg - topiramate 25mg - miscellaneous anticonvulsants

Canadá - inglés - Health Canada

glenmark pharmaceuticals canada inc. - topiramate - tablet - 25mg - topiramate 25mg - miscellaneous anticonvulsants

Canadá - inglés - Health Canada

glenmark pharmaceuticals canada inc. - topiramate - tablet - 25mg - topiramate 25mg - miscellaneous anticonvulsants

Canadá - inglés - Health Canada

nu-pharm inc - topiramate - tablet - 25mg - topiramate 25mg - miscellaneous anticonvulsants

Estados Unidos - inglés - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 100 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1)]. topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients  2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.2)]. none. pregnancy category d  [see warnings and precautions (5.7)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). when multiple species of pregnant animals received

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

actavis new zealand limited - topiramate 25mg - film coated tablet - 25 mg - active: topiramate 25mg excipient: aniseed flavour 501007 bp0551 lactose magnesium stearate microcrystalline cellulose opadry white oy-b-28920 amb pregelatinised maize starch purified water saccharin sodium sodium starch glycolate - arrow - topiramate is indicated in adults and children 2 years** and over: · as monotherapy in patients with newly diagnosed epilepsy · for conversion to monotherapy in patients with epilepsy · as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with lennox-gastaut syndrome. **arrow-topiramate tablet range cannot deliver lower doses required for younger paediatric patients .

Estados Unidos - inglés - NLM (National Library of Medicine)

physicians total care, inc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product. the abuse and dependence potential of topiramate has not been evaluated in human studies.

Estados Unidos - inglés - NLM (National Library of Medicine)

blenheim pharmacal, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets usp are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1) ]. topiramate tablets usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.1) ] none. [see warnings and precautions (5.6)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero