오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

swedish orphan biovitrum pty ltd - anakinra, quantity: 100 mg - injection, solution - excipient ingredients: polysorbate 80; sodium citrate dihydrate; water for injections; disodium edetate; sodium chloride - kineret (anakinra) is indicated: -for the treatment of active adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more other disease modifying anti rheumatic drugs (dmards). kineret should be given in combination with methotrexate. - in adult and paediatric patients aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (caps) including neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca), muckle-wells syndrome (mws), and familial cold autoinflammatory syndrome (fcas). - for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 2 years and above who have failed to respond adequately to non-biological dmards

미국 - 영어 - NLM (National Library of Medicine)

swedish orphan biovitrum ab (publ) - emapalumab (unii: 3s252o2z4x) (emapalumab - unii:3s252o2z4x) - gamifant is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (hlh) with refractory, recurrent or progressive disease or intolerance with conventional hlh therapy. none. risk summary there are no available data on gamifant use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in an animal reproduction study, a murine surrogate anti-mouse ifnγ antibody administered to pregnant mice throughout gestation crossed the placental barrier, and no fetal harm was observed (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. 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. data animal data in a mouse embryo-fetal development

유럽 연합 - 영어 - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mucositis - all other therapeutic products - kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.

유럽 연합 - 영어 - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinone - tyrosinemias - other alimentary tract and metabolism products, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine.alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

캐나다 - 영어 - Health Canada

biovitrum ab (publ) - ancestim; water - kit - 1875mcg; 5ml - ancestim 1875mcg; water 5ml - hematopoietic agents

캐나다 - 영어 - Health Canada

swedish orphan biovitrum ab (publ) - pegcetacoplan - solution - 1080mg - pegcetacoplan 1080mg

캐나다 - 영어 - Health Canada

swedish orphan biovitrum ab (publ) - avatrombopag (avatrombopag maleate) - tablet - 20mg - avatrombopag (avatrombopag maleate) 20mg

캐나다 - 영어 - Health Canada

swedish orphan biovitrum ab (publ) - palifermin - powder for solution - 6.25mg - palifermin 6.25mg - cell stimulants and proliferants

유럽 연합 - 영어 - EMA (European Medicines Agency)

swedish orphan biovitrum ab - collagenase clostridium histolyticum - dupuytren contracture - other drugs for disorders of the musculo-skeletal system - , the treatment of dupuytren’s contracture in adult patients with a palpable cord., the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

캐나다 - 영어 - Health Canada

swedish orphan biovitrum ab (publ) - anakinra - solution - 150mg - anakinra 150mg - disease-modifying antirheumatic agents