Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

grifols malaysia sdn. bhd. - factor viii/antihaemophilic factor/ahf -

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

roche products pty ltd - emicizumab, quantity: 60 mg - injection, solution - excipient ingredients: poloxamer; arginine; aspartic acid; water for injections; histidine - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 30 mg - injection, solution - excipient ingredients: arginine; water for injections; histidine; aspartic acid; poloxamer - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 150 mg - injection, solution - excipient ingredients: aspartic acid; histidine; arginine; poloxamer; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 105 mg - injection, solution - excipient ingredients: arginine; poloxamer; aspartic acid; histidine; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - dried factor viii fraction 1000 [iu]; von willebrand's factor : ristocetin cofactor 2000 [iu] - injection with diluent - 1000 iu - active: dried factor viii fraction 1000 [iu] von willebrand's factor : ristocetin cofactor 2000 [iu] excipient: albumin calcium chloride dihydrate plasma protein sodium chloride sodium citrate dihydrate sucrose trometamol water for injection - biostate® is indicated for: · the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - dried factor viii fraction 500 [iu]; von willebrand's factor : ristocetin cofactor 1000 [iu] - injection with diluent - 500 iu - active: dried factor viii fraction 500 [iu] von willebrand's factor : ristocetin cofactor 1000 [iu] excipient: albumin calcium chloride dihydrate plasma protein sodium chloride sodium citrate dihydrate sucrose trometamol water for injection - biostate® is indicated for: · the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated

Singapore - English - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - anti inhibitor coagulant complex - injection, powder, for solution - 50 u/ml - anti inhibitor coagulant complex 50 u/ml

Singapore - English - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - anti inhibitor coagulant complex - injection, powder, for solution - 25 u/ml - anti inhibitor coagulant complex 25 u/ml

United States - English - NLM (National Library of Medicine)

csl behring llc - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 500 [iu] in 5 ml - mononine is indicated for the prevention and control of bleeding in factor ix deficiency, also known as hemophilia b or christmas disease. mononine is not indicated in the treatment or prophylaxis of hemophilia a patients with inhibitors to factor viii. mononine contains non-detectable levels of factors ii, vii and x (<0.0025 iu per factor ix unit using standard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors. mononine is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors. known hypersensitivity to mouse protein is a contraindication to mononine.