European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - susoctocog alfa - hemophilia a - antihemorrhagics - treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to factor viii. obizur is indicated in adults.

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

takeda pharmaceuticals australia pty ltd - susoctocog alfa, quantity: 500 u/ml - injection - excipient ingredients: - for the treatment of bleeding episodes in adults with acquired haemophilia a.,safety and efficacy of obizur have not been established in patients with baseline anti- porcine factor viii inhibitor titre greater than 20 bu.,obizur is not indicated for the treatment of congenital haemophilia a or von willebrand disease.

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

baxalta us inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 5 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. adynovate should be given to a pregnant woman only

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - rurioctocog alfa pegol - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia a (congenital factor viii deficiency).

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

csl behring australia pty ltd - factor viii, quantity: 1000 iu; von willebrand factor, quantity: 2400 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - nonacog gamma - hemophilia b - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Malta - English - Medicines Authority

kedrion s.p.a loc. ai conti, 55051 castelvecchio pascoli, barga - lucca, italy - factor ix, human - powder and solvent for solution for infusion - factor ix, human 500 iu - antihemorrhagics

Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - factor ii, prothrombin, factor vii, human, factor x, factor ix, protein c - powder and solvent for solution for injection - factor ii (prothrombin) 20-48 iu factor vii, human 10-25 iu factor x, human 22-60 iu factor ix, human 20-31 iu protein c 15-45 iu - antihemorrhagics

Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - factor ii, prothrombin, factor vii, human, factor ix, factor x, protein c - powder and solvent for solution for injection - factor ii (prothrombin) 20-48 iu factor vii, human 10-25 iu factor ix, human 20-31 iu factor x, human 22-60 iu protein c 15-45 iu - antihemorrhagics

Malta - English - Medicines Authority

bpl bioproducts laboratory gmbh dornhofstraße 34, 63263 neu-isenburg,, germany - factor ix, human - powder for solution for injection - factor ix, human 50 iu/ml - antihemorrhagics