アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

jacobus pharmaceutical company,inc - amifampridine (unii: ru4s6e2g0j) (amifampridine - unii:ru4s6e2g0j) - ruzurgi is indicated for the treatment of lambert-eaton myasthenic syndrome (lems) in patients 6 to less than 17 years of age. ruzurgi is contraindicated in patients with: - a history of seizures [see warnings and precautions (5.1)] - hypersensitivity to amifampridine or another aminopyridine [see warnings and precautions (5.2)] risk summary there are no data on the developmental risk associated with the use of ruzurgi in pregnant women. animal studies to assess the potential adverse effects of amifampridine on embryofetal development have not been conducted. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. risk summary there are no data on the presence of amifampridine or the 3-n-acetyl-amifampridine metabolite in human milk, the effects on the breastfed infant, or the effects on mi

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

lacuna pharma pty ltd - amifampridine, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a; calcium hydrogen phosphate dihydrate; microcrystalline cellulose - ruzurgi is indicated for the treatment of lambert-eaton myasthenic syndrome (lems) in adults and children aged 6 years and above.

イギリス - 英語 - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - amifampridine phosphate - tablet - 10mg

欧州連合 - 英語 - 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.

カナダ - 英語 - Health Canada

kye pharmaceuticals inc. - amifampridine (amifampridine phosphate) - tablet - 10mg - amifampridine (amifampridine phosphate) 10mg - miscellaneous central nervous system agents

カナダ - 英語 - Health Canada

medunik canada - amifampridine - tablet - 10mg - amifampridine 10mg - miscellaneous central nervous system agents

イスラエル - 英語 - Ministry of Health

medison pharma ltd - amifampridine - tablets - amifampridine 10 mg - amifampridine - symptomatic treatment of lambert-eaton myasthenic syndrome (lems) in adults

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

catalyst pharmaceuticals, inc. - amifampridine phosphate (unii: 8hf8fin815) (amifampridine - unii:ru4s6e2g0j) - firdapse® is indicated for the treatment of lambert-eaton myasthenic syndrome (lems) in adults and pediatric patients 6 years of age and older. firdapse is contraindicated in patients with: - a history of seizures [see warnings and precautions (5.1)] - hypersensitivity to amifampridine phosphate or another aminopyridine [see warnings and precautions (5.2)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to firdapse during pregnancy. physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the registry by calling 855-212-5856 (toll-free), using the fax number 877-867-1874 (toll-free), by contacting the pregnancy coordinating center at firdapsepregnancyregistry@ubc.com, or by visiting the study website www.firdapsepregnancystudy.com. risk summary there are no data on the developmental risk associated with the use of firdapse in pregnant women. in animal studies, administration of amifampridine phosph

イギリス - 英語 - MHRA (Medicines & Healthcare Products Regulatory Agency)

biomarin europe ltd - amifampridine phosphate - tablet - 10mg

イギリス - 英語 - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - amifampridine phosphate - oral tablet - 10mg