Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

prothya biosolutions netherlands b.v. - human coagulation factor x 14 iu/ml - 35 iu/ml; human coagulation factor vii 7 iu/ml - 20 iu/ml; human coagulation factor ix 25 iu/ml; human coagulation factor ii 14 iu/ml - 35 iu/ml - powder and solvent for solution for injection - 500 iu - human coagulation factor ix 25 iu/ml; human coagulation factor vii; human coagulation factor ii; human coagulation factor x - coagulation factor ix, ii, vii and x in combination

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

Israel - English - Ministry of Health

csl behring ltd., israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein c; protein s antigen - powder and solvent for solution for injection - coagulation factor ii (human) 400 - 960 iu; coagulation factor vii (human) 200 - 500 iu; coagulation factor ix (human- rfixfc) 400 - 620 iu; coagulation factor x (human) 440 - 1200 iu; protein c 300 - 900 iu; protein s antigen 240 - 760 iu - coagulation factor ix, ii, vii and x in combination - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

instituto grifols, s.a, spain - coagulation factor ix recombinant human - powder for solution for injection - 40-62.5 iu/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

instituto grifols, s.a, spain - coagulation factor ix recombinant human - powder for solution for injection - 40-62.5 iu/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

instituto grifols, s.a, spain - coagulation factor ix recombinant human - powder for solution for injection - 40-62.5 iu/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

instituto grifols, s.a, spain - coagulation factor ix recombinant human - powder for solution for injection - 40-62.5 iu/ml

Israel - English - Ministry of Health

takeda israel ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for injection/infusion - factor viii inhibitor bypassing fraction 500 u/vial - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - control of bleeding episodes in haemophilia a patients with factor viii inhibitors and also in patients with acquired factor viii inhibitors.control of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) - injection with diluent - 1000 iu - active: factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml water for injections) - injection with diluent - 500 iu - active: factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml water for injections) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.