加拿大 - 英文 - Health Canada

swedish orphan biovitrum ab (publ) - nitisinone - capsule - 2mg - nitisinone 2mg - other miscellaneous therapeutic agents

加拿大 - 英文 - Health Canada

swedish orphan biovitrum ab (publ) - nitisinone - capsule - 5mg - nitisinone 5mg - other miscellaneous therapeutic agents

加拿大 - 英文 - Health Canada

swedish orphan biovitrum ab (publ) - nitisinone - capsule - 10mg - nitisinone 10mg - other miscellaneous therapeutic agents

加拿大 - 英文 - Health Canada

swedish orphan biovitrum ab (publ) - nitisinone - capsule - 20mg - nitisinone 20mg - other miscellaneous therapeutic agents

美国 - 英文 - NLM (National Library of Medicine)

swedish orphan biovitrum ab (publ) - nitisinone (unii: k5bn214699) (nitisinone - unii:k5bn214699) - nitisinone 4 mg in 1 ml - orfadin ® is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine. none. risk summary limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. animal reproduction studies have been conducted for nitisinone. in these studies, nitisinone was administered to mice and rabbits during organogenesis with oral doses of nitisinone up to 20 and 8 times respectively, the recommended initial dose of 1 mg/kg/day. in mice, nitisinone caused incomplete skeletal ossification of fetal bones and decreased pup survival at doses 0.4 times the recommended initial dose, and increased gestational length at doses 4 times the recommended initial dose. in rabbits, nitisinone caused maternal toxicity and incomplete skeletal ossification of fetal bones at doses 1.6 times the recommended initial dose

美国 - 英文 - NLM (National Library of Medicine)

swedish orphan biovitrum ab (publ) - palifermin (unii: qms40680k6) (palifermin - unii:qms40680k6) - palifermin 6.25 mg in 1.2 ml - kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ who grade 3 mucositis in the majority of patients. kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ who grade 3 mucositis in the majority of patients. the safety and efficacy of kepivance have not been established in patients with non-hematologic malignancies )]. the safety and efficacy of kepivance have not been established in patients with non-hematologic malignancies

美国 - 英文 - NLM (National Library of Medicine)

swedish orphan biovitrum ab (publ) - nitisinone (unii: k5bn214699) (nitisinone - unii:k5bn214699) - nitisinone 2 mg - orfadin® is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine. none. risk summary limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. animal reproduction studies have been conducted for nitisinone. in these studies, nitisinone was administered to mice and rabbits during organogenesis with oral doses of nitisinone up to 20 and 8 times respectively, the recommended initial dose of 1 mg/kg/day. in mice, nitisinone caused incomplete skeletal ossification of fetal bones and decreased pup survival at doses 0.4 times the recommended initial dose, and increased gestational length at doses 4 times the recommended initial dose. in rabbits, nitisinone caused maternal toxicity and incomplete skeletal ossification of fetal bones at doses 1.6 times the recommended initial dose [see data] . the backgroun

美国 - 英文 - NLM (National Library of Medicine)

swedish orphan biovitrum ab (publ) - anakinra (unii: 9013duq28k) (anakinra - unii:9013duq28k) - anakinra 100 mg in 0.67 ml - kineret is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (ra), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (dmards). kineret can be used alone or in combination with dmards other than tumor necrosis factor (tnf) blocking agents [see warnings and precautions (5.2)]. kineret is indicated for the treatment of neonatal-onset multisystem inflammatory disease (nomid). kineret is indicated for the treatment of deficiency of interleukin-1 receptor antagonist (dira) kineret is contraindicated in patients with known hypersensitivity to e coli -derived proteins, kineret, or any components of the product [see hypersensitivity reactions (5.3)] . risk summary available data from retrospective studies and case reports on kineret use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage, or maternal and fetal adv

加拿大 - 英文 - Health Canada

swedish orphan biovitrum ab (publ) - nitisinone - suspension - 4mg - nitisinone 4mg - other miscellaneous therapeutic agents

欧盟 - 英文 - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - thrombocytopenia - antihemorrhagics - doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).