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

chiesi australia pty ltd - stiripentol, quantity: 500 mg - powder, oral - excipient ingredients: sodium starch glycollate type a; povidone; spray-dried liquid glucose; erythrosine; titanium dioxide; aspartame; carmellose; hyetellose; flavour - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

chiesi australia pty ltd - stiripentol, quantity: 250 mg - powder, oral - excipient ingredients: sodium starch glycollate type a; povidone; spray-dried liquid glucose; erythrosine; titanium dioxide; aspartame; carmellose; hyetellose; flavour - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

chiesi australia pty ltd - stiripentol, quantity: 500 mg - capsule - excipient ingredients: sodium starch glycollate type a; magnesium stearate; povidone; gelatin; titanium dioxide; iron oxide black; shellac - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

chiesi australia pty ltd - stiripentol, quantity: 250 mg - capsule - excipient ingredients: sodium starch glycollate type a; magnesium stearate; povidone; gelatin; titanium dioxide; erythrosine; indigo carmine; shellac; iron oxide black - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

biocodex, inc. - stiripentol (unii: r02xot8v8i) (stiripentol - unii:r02xot8v8i) - diacomit is indicated for the treatment of seizures associated with dravet syndrome (ds) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. there are no clinical data to support the use of diacomit as monotherapy in dravet syndrome. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as diacomit, during pregnancy. physicians are advised to recommend that pregnant patients taking diacomit enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of diacomit in pregnant women. administration of stiripentol to pregnant animals produced evidence of development

European Union - English - EMA (European Medicines Agency)

biocodex - stiripentol - myoclonic epilepsy, juvenile - antiepileptics, - diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (smei, dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.

Canada - English - Health Canada

biocodex sas - stiripentol - capsule - 250mg - stiripentol 250mg - miscellaneous anticonvulsants

Canada - English - Health Canada

biocodex sas - stiripentol - capsule - 500mg - stiripentol 500mg - miscellaneous anticonvulsants

Canada - English - Health Canada

biocodex sas - stiripentol - powder for suspension - 250mg - stiripentol 250mg - miscellaneous anticonvulsants

Canada - English - Health Canada

biocodex sas - stiripentol - powder for suspension - 500mg - stiripentol 500mg - miscellaneous anticonvulsants