New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - octocog alfa 2000 [iu] (recombinant factor viii) - injection with diluent - 2000 iu - active: octocog alfa 2000 [iu] (recombinant factor viii) excipient: calcium chloride glycine histidine polysorbate 80 sodium chloride sucrose water for injection water for injection - kogenate fs is indicated in congenital factor viii deficiency (haemophilia a) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - octocog alfa 3000 [iu] (recombinant factor viii) - injection with diluent - 3000 iu - active: octocog alfa 3000 [iu] (recombinant factor viii) excipient: calcium chloride glycine histidine polysorbate 80 sodium chloride sucrose water for injection water for injection - kogenate fs is indicated in congenital factor viii deficiency (haemophilia a) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu - antihemorrhagics

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu/ml - antihemorrhagics

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - factor viii, human - powder and solvent for solution for injection - factor viii, human 100 iu/ml - antihemorrhagics

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human factor viii; von willebrand factor human - powder and solvent for solution for injection - 500/500 international unit(s) - blood coagulation factors; von willebrand factor and coagulation factor viii in combination

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human factor viii; von willebrand factor human - powder and solvent for solution for injection - 1000/1000 international unit(s) - blood coagulation factors; von willebrand factor and coagulation factor viii in combination

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - factor viii, inhibitor bypassing, fraction - powder and solvent for solution for infusion - factor viii inhibitor bypassing fraction 25 u/ml - 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).

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 500 iu/vial; factor viii (human) 500 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).