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).

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

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.

Australia - English - Department of Health (Therapeutic Goods Administration)

swedish orphan biovitrum pty ltd - pegcetacoplan, quantity: 1080 mg - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium acetate trihydrate; glacial acetic acid; sorbitol - empaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who have an inadequate response to, or are intolerant of, a c5 inhibitor.

Australia - English - Department of Health (Therapeutic Goods Administration)

swedish orphan biovitrum pty ltd - avatrombopag maleate, quantity: 23.6 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.,doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (itp) who have had an insufficient response to a previous treatment.

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