Malta - English - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - factor viii, human - powder and solvent for solution for injection - factor viii, human 25 iu/ml - antihemorrhagics

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - factor viii; von willebrand factor - powder and solvent for solution for injection - 500unit ; 1000unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - von willebrand factor; factor viii - powder and solvent for solution for injection - 500unit ; 250unit

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.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - moroctocog alfa - lyophylized powder and solvent for solution for injection - moroctocog alfa 500 iu/vial - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency)

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - moroctocog alfa - powder and solvent for solution for injection - moroctocog alfa 1000 iu/vial - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency)

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - moroctocog alfa - powder and solvent for solution for injection - moroctocog alfa 2000 iu/vial - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency)

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - coagulation factor ix recombinant-rfix - lyophilized powder for injection - coagulation factor ix recombinant-rfix 250 iu/vial - coagulation factor ix - coagulation factor ix - benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (ptp) and previously untreated patients (pup). benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii,vii, and x)' nor for the treatment of hemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - coagulation factor ix recombinant-rfix - lyophilized powder for injection - coagulation factor ix recombinant-rfix 500 iu/vial - coagulation factor ix - coagulation factor ix - benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (ptp) and previously untreated patients (pup).benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii,vii, and x)' nor for the treatment of hemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.