Malta - engleski - Medicines Authority

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

Filipini - engleski - 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

Australija - engleski - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor ix -

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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

Novi Zeland - engleski - 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.

Novi Zeland - engleski - 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.

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

grifols uk ltd - factor viii high purity; von willebrand factor - powder and solvent for solution for injection - 500unit ; 200unit

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

grifols uk ltd - factor viii high purity; von willebrand factor - powder and solvent for solution for injection - 1000unit ; 1200unit

Armenija - engleski - 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