Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

biomarin europe ltd - amifampridine phosphate - tablet - 10mg

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - amifampridine phosphate - oral tablet - 10mg

Израиль - английский - Ministry of Health

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

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - amifampridine - oral tablet - 20mg

Мальта - английский - Medicines Authority

cherubino limited delf building, sliema road, gzira, gzr 1637, malta - tablet - amifampridine 10 mg - other nervous system drugs

Соединенные Штаты - английский - NLM (National Library of Medicine)

ascend laboratories, llc - 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 are contraindicated in the following conditions: - history of seizure [see warnings and precautions (5.1)] - moderate or severe renal impairment (crcl≤50 ml/min) [see warnings and precautions (5.2)] - history of hypersensitivity to dalfampridine extended-release tablets or 4-aminopyridine; reactions have included anaphylaxis [see warnings and precautions (5.4)] risk summary there are no adequate data on the developmental risk associated with use of dalfampridine extended-release tablets in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see data]. in the u.s. general population, the estimated background risk of major bi

Соединенные Штаты - английский - NLM (National Library of Medicine)

sun pharmaceutical industries, 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 are contraindicated in the following conditions: - history of seizure [see warnings and precautions (5.1)] - moderate or severe renal impairment (crcl ≤ 50 ml/min) [see warnings and precautions (5.2)] - history of hypersensitivity to dalfampridine or 4-aminopyridine; reactions have included anaphylaxis [see warnings and precautions (5.4)] risk summary there are no adequate data on the developmental risk associated with use of dalfampridine in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognize

Соединенные Штаты - английский - 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