Malta - English - Medicines Authority

bio products laboratory limited - factor ix, human - powder for solution for injection - factor ix, human 50 international unit(s)/millilitre - antihemorrhagics

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: new marketlink pharmaceutical corporation; distributor: metro drug inc. - human plasma coagulation factor viii - lyophilized powder for injection (iv) - 500 iu

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

csl behring australia pty ltd - factor ix -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga marketing sdn bhd - coagulation factor viii; von willebrand factor -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga marketing sdn bhd - coagulation factor viii; von willebrand factor -

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] (50 iu/ml when reconstituted with 10 ml water for injections) - injection with diluent - 50 iu/ml - active: factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml 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.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

octapharma pharmazeutika produktionsges. m.b.h. - human blood coagulation factor viii, human von willebrand factor - powder for solution for i/v injection - 500iu/5ml+ 500iu/5ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

octapharma pharmazeutika produktionsges. m.b.h. - human blood coagulation factor viii, human von willebrand factor - powder for solution for i/v injection - 1000iu/10ml+ 1000iu/10ml

Singapore - English - HSA (Health Sciences Authority)

wellchem pharmaceuticals pte ltd - coagulation factor viii (human) - injection, powder, for solution - 250 iu/5 ml - coagulation factor viii (human) 250 iu/5 ml vial