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

sanofi-aventis australia pty ltd - eftrenonacog alfa, quantity: 4000 iu - drug delivery system - excipient ingredients: - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - nonacog alfa 1000 [iu] (actually contains 1100 iu which includes 10% overage); nonacog alfa 1000 [iu] (actually contains 1100 iu which includes 10% overage) - powder for injection with diluent - 1000 iu - active: nonacog alfa 1000 [iu] (actually contains 1100 iu which includes 10% overage) excipient: glycine histidine polysorbate 80 sucrose water for injection active: nonacog alfa 1000 [iu] (actually contains 1100 iu which includes 10% overage) excipient: glycine histidine polysorbate 80 sucrose sodium chloride water for injection - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - nonacog alfa 250 [iu] (actual amount is 275 iu which includes 10% overage); nonacog alfa 250 [iu] (actual amount is 275 iu which includes 10% overage) - powder for injection with diluent - 250 iu - active: nonacog alfa 250 [iu] (actual amount is 275 iu which includes 10% overage) excipient: glycine histidine polysorbate 80 sucrose water for injection sodium chloride water for injection active: nonacog alfa 250 [iu] (actual amount is 275 iu which includes 10% overage) excipient: glycine histidine polysorbate 80 sucrose - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - nonacog alfa 500 [iu] (actually contains 550 iu which includes 10% overage); nonacog alfa 500 [iu] (actually contains 550 iu which includes 10% overage) - powder for injection with diluent - 500 iu - active: nonacog alfa 500 [iu] (actually contains 550 iu which includes 10% overage) excipient: glycine histidine polysorbate 80 sucrose water for injection active: nonacog alfa 500 [iu] (actually contains 550 iu which includes 10% overage) excipient: glycine histidine polysorbate 80 sucrose sodium chloride water for injection - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - nonacog alfa 2000 [iu] (+ 10% overage) - powder for injection with diluent - 2000 iu - active: nonacog alfa 2000 [iu] (+ 10% overage) excipient: glycine histidine polysorbate 80 sucrose sodium chloride water for injection - 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.

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - eftrenonacog alfa - hemophilia b - vitamin k and other hemostatics, blood coagulation factors - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - nonacog alfa - hemophilia b - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor-ix deficiency).,

European Union - English - EMA (European Medicines Agency)

csl behring gmbh - albutrepenonacog alfa - hemophilia b - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

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).

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 1000 [iu];   - powder for infusion - 1000 iu - active: eftrenonacog alfa 1000 [iu]   excipient: histidine mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)