European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - efmoroctocog alfa - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).

European Union - English - 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.

United States - English - 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

Australia - English - 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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - efmoroctocog alfa - powder and solvent for solution for injection - 1000unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - efmoroctocog alfa - powder and solvent for solution for injection - 1500unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - efmoroctocog alfa - powder and solvent for solution for injection - 2000unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - efmoroctocog alfa - powder and solvent for solution for injection - 250unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - efmoroctocog alfa - powder and solvent for solution for injection - 3000unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - efmoroctocog alfa - powder and solvent for solution for injection - 500unit