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

arrotex pharmaceuticals pty ltd - fampridine, quantity: 10 mg - tablet, modified release - excipient ingredients: purified talc; titanium dioxide; colloidal anhydrous silica; hypromellose; macrogol 8000; magnesium stearate; polyvinyl alcohol; microcrystalline cellulose - apo-fampridine mr modified release tablets are indicated for the symptomatic improvement of walking ability in adult patients with multiple sclerosis who have shown improvement after 8 weeks of treatment.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridine - multiple sclerosis - other nervous system drugs - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7). 

Canada - English - Health Canada

taro pharmaceuticals inc - fampridine - tablet (extended-release) - 10mg - fampridine 10mg - other miscellaneous therapeutic agents

Canada - English - Health Canada

pharmascience inc - fampridine - tablet (extended-release) - 10mg - fampridine 10mg - other miscellaneous therapeutic agents

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

arrotex pharmaceuticals pty ltd - fampridine, quantity: 10 mg - tablet, modified release - excipient ingredients: magnesium stearate; colloidal anhydrous silica; macrogol 8000; polyvinyl alcohol; titanium dioxide; hypromellose; purified talc; microcrystalline cellulose - fampridine mr apotex modified release tablets are indicated for the symptomatic improvement of walking ability in adult patients with multiple sclerosis who have shown improvement after 8 weeks of treatment.

European Union - English - EMA (European Medicines Agency)

serb sa - amifampridine phosphate - lambert-eaton myasthenic syndrome; paraneoplastic syndromes, nervous system; nervous system neoplasms; paraneoplastic syndromes; nervous system diseases; autoimmune diseases of the nervous system; neurodegenerative diseases; neuromuscular diseases; neuromuscular junction diseases; immune system diseases; autoimmune diseases; autoimmune diseases of the nervous system; cancer; neoplasms - other nervous system drugs - symptomatic treatment of lambert-eaton myasthenic syndrome (lems) in adults.

Malta - English - Medicines Authority

rontis hellas medical and pharmaceutical products s.a. 38, sorou str., athens, maroussi, 15125, greece - fampridine - prolonged-release tablet - fampridine 10 mg - other nervous system drugs

Ireland - English - HPRA (Health Products Regulatory Authority)

rowa pharmaceuticals limited - fampridine - prolonged-release tablet - fampridine

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - fampridine 10mg - modified release tablet - 10 mg - active: fampridine 10mg excipient: colloidal silicon dioxide hypromellose macrogol 8000 magnesium stearate microcrystalline cellulose polyvinyl alcohol purified talc purified water titanium dioxide - apo-fampridine modified release tablets are indicated for the symptomatic improvement of walking ability in adult patients with multiple sclerosis who have shown improvement after 8 weeks of treatment.

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

mylan pharmaceuticals inc. - dalfampridine (unii: bh3b64okl9) (dalfampridine - unii:bh3b64okl9) - dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (ms). this was demonstrated by an increase in walking speed [see clinical studies (14)]. the use of dalfampridine extended-release tablets is contraindicated in the following conditions: there are no adequate and well-controlled studies of dalfampridine in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at doses similar to the maximum recommended human dose (mrhd) of 20 mg/day. dalfampridine extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in developmental toxicity studies in rats and rabbits, dalfampridine was administered orally at doses up to 10 and 5 mg/kg/day, respectively, during the period of organogenesis. these doses are approximately 5 times the mrhd on a body surface area (mg/m2 ) basis. no evidence