New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - moroctocog alfa 1000 [iu] equivalent to 90 µg;   - injection with diluent - 1000 iu - active: moroctocog alfa 1000 [iu] equivalent to 90 µg   excipient: calcium chloride dihydrate histidine polysorbate 80 sodium chloride sucrose sodium chloride water for injection - xyntha is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia a, including control and prevention of bleeding in surgical settings. xyntha does not contain von willebrand factor and should not be used by patients with von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - moroctocog alfa 2000 [iu] equivalent to 180 µg;   - injection with diluent - 2000 iu - active: moroctocog alfa 2000 [iu] equivalent to 180 µg   excipient: calcium chloride dihydrate histidine polysorbate 80 sodium chloride sucrose sodium chloride water for injection - xyntha is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia a, including control and prevention of bleeding in surgical settings. xyntha does not contain von willebrand factor and should not be used by patients with von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - moroctocog alfa 250 [iu] equivalent to 23 µg;   - injection with diluent - 250 iu - active: moroctocog alfa 250 [iu] equivalent to 23 µg   excipient: calcium chloride dihydrate histidine polysorbate 80 sodium chloride sucrose sodium chloride water for injection - xyntha is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia a, including control and prevention of bleeding in surgical settings. xyntha does not contain von willebrand factor and should not be used by patients with von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - moroctocog alfa 500 [iu] equivalent to 45 µg;   - injection with diluent - 500 iu - active: moroctocog alfa 500 [iu] equivalent to 45 µg   excipient: calcium chloride dihydrate histidine polysorbate 80 sodium chloride sucrose sodium chloride water for injection - xyntha is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia a, including control and prevention of bleeding in surgical settings. xyntha does not contain von willebrand factor and should not be used by patients with von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - moroctocog alfa 3000 [iu];   - injection with diluent - 3000 iu - active: moroctocog alfa 3000 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 80 sodium chloride sucrose sodium chloride water for injection - xyntha is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia a, including control and prevention of bleeding in surgical settings. xyntha does not contain von willebrand factor and should not be used by patients with von willebrand's disease.

Israel - English - Ministry of Health

megapharm ltd - palifermin 6.25 mg/vial - solution for injection - palifermin - kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in patients with haematological malignancies receiving myeloablative therapy associated with a high incidence of severe mucositis and requiring autologous haemopoietic 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

Israel - English - Ministry of Health

megapharm ltd - coagulation factor ix (human- rfixfc) - powder and solvent for solution for injection - coagulation factor ix (human- rfixfc) 1000 iu/vial - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Israel - English - Ministry of Health

megapharm ltd - coagulation factor ix (human- rfixfc) - powder and solvent for solution for injection - coagulation factor ix (human- rfixfc) 2000 iu/vial - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Israel - English - Ministry of Health

megapharm ltd - coagulation factor ix (human- rfixfc) - powder and solvent for solution for injection - coagulation factor ix (human- rfixfc) 250 iu/vial - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).