ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 100mg - chewable/dispersible tablet - 100 mg - active: lamotrigine 100mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 200mg - chewable/dispersible tablet - 200 mg - active: lamotrigine 200mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 25mg - chewable/dispersible tablet - 25 mg - active: lamotrigine 25mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 50mg - chewable/dispersible tablet - 50 mg - active: lamotrigine 50mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

ישראל - אנגלית - Ministry of Health

eisai israel ltd., israel - rufinamide - film coated tablets - rufinamide 200 mg - rufinamide - rufinamide - inovelon is indicated as adjunctive therapy in the treatment of seizures associated with lennox gastaut syndrome in patients 1 year of age and older.

ישראל - אנגלית - Ministry of Health

eisai israel ltd., israel - rufinamide - film coated tablets - rufinamide 400 mg - rufinamide - rufinamide - inovelon is indicated as adjunctive therapy in the treatment of seizures associated with lennox gastaut syndrome in patients 1 year of age and older.

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

eisai gmbh - rufinamide - epilepsy - antiepileptics, - inovelon is indicated as adjunctive therapy in the treatment of seizures associated with lennox gastaut syndrome in patients 4 years of age and older.

ארצות הברית - אנגלית - 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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

unit dose services - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 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 receiv