Malta - English - Medicines Authority

takeda manufacturing austria ag industriestrasse 67, a-1221, vienna, austria - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 1000 iu von willebrand factor, human 750 iu - antihemorrhagics

United Kingdom - English - myHealthbox

octapharma limited - human coagulation factor viii, willebrand factor (vwf:rco) - powder and solvent for solution for injection - 500iu, 60iu - antihemorrhagics: blood coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency)

United Kingdom - English - myHealthbox

octapharma limited - human coagulation factor viii, willebrand factor (vwf:rco) - powder and solvent for solution for injection - 200iu, 120iu - antihemorrhagics: blood coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency)

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

biogen inc. - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) (unii: 7pcm518ylr) ((1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) - unii:7pcm51 - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) 250 [iu] in 3 ml - eloctate, antihemophilic factor (recombinant), fc fusion protein, is a recombinant dna derived, antihemophilic factor indicated in adults and children with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes, - perioperative management of bleeding, - routine prophylaxis to reduce the frequency of bleeding episodes. limitation of use eloctate is not indicated for the treatment of von willebrand disease. eloctate is contraindicated in patients who have had life-threatening hypersensitivity reactions to eloctate or other constituents of the product. [see description (11 )] risk summary there are no studies of eloctate use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the u.s. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. animal reproductive and devel

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

Namibia - English - Namibia Medicines Regulatory Council

national bioproducts institute - factor viii, factor viii : vwf - lyophilised powder - each 10ml solution contains factor viii : c500 iu, factor viii : vwf more than 500 iu

Namibia - English - Namibia Medicines Regulatory Council

national bioproducts institute - factor viii , factor viii : vwf, protein - lyophilised powder - each 10ml solution contains factor viii : c300 iu, factor viii : vwf more than 300 iu, protein 0.16g

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - factor viii, human 250 [iu] (factor viii ex nz) - injection with diluent - 250 iu/10ml - active: factor viii, human 250 [iu] (factor viii ex nz) excipient: chloride citrate sodium sucrose trometamol water for injection

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

csl behring australia pty ltd - von willebrand factor, quantity: 1200 iu; factor viii, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - aleviate is indicated for: ? 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 fviii deficiency due to haemophilia a.