Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - factor viii, human - powder and solvent for solution for injection - factor viii, human 100 iu/ml - antihemorrhagics

Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu - antihemorrhagics

Israel - English - Ministry of Health

dover medical & scientific equipment ltd, israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection - von willebrand factor 1000 iu/vial; factor viii (human) 1000 iu/vial - coagulation factor viii - von willebrand disease (vwd) :prevention and treatment of haemorrhage or surgical bleeding in von willebrand disease (vwd), when desmopressin (ddavp) treatment alone is ineffective or contra-indicated.haemophilia a :treatment and prophylaxis of bleeding in patients with haemophilia a (congenital fviii deficiency).

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

pfizer australia pty ltd - nonacog alfa, quantity: 2000 iu - injection, powder for - excipient ingredients: glycine; sucrose; polysorbate 80; histidine - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

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

pfizer australia pty ltd - nonacog alfa, quantity: 1000 iu - injection, powder for - excipient ingredients: polysorbate 80; histidine; sucrose; glycine - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

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

pfizer australia pty ltd - nonacog alfa, quantity: 500 iu - injection, powder for - excipient ingredients: sucrose; histidine; polysorbate 80; glycine - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

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

pfizer australia pty ltd - nonacog alfa, quantity: 250 iu - injection, powder for - excipient ingredients: polysorbate 80; histidine; glycine; sucrose - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Israel - English - Ministry of Health

kamada ltd, israel - factor ix - powder for solution for injection - factor ix 50 iu/ml - coagulation factor ix, ii, vii and x in combination - treatment and prophylaxis of bleeding in patients with haemophilia b ( congenital factor ix deficiency).

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - human plasmafraktion (factor viii) - pdr for soln for injection - 500 international unit

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - antihemophilic factor (human) (factor viii) - injection, powder, for solution - min 400 iu/5 ml - antihemophilic factor (human) (factor viii) min 400 iu/5 ml