Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - factor viii, human - powder and solvent for solution for injection - factor viii, human 100 iu/ml - antihemorrhagics

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

grifols usa, llc - human coagulation factor viii/von willebrand factor complex (unii: 5t6b772r4q) (human coagulation factor viii/von willebrand factor complex - unii:5t6b772r4q) - human coagulation factor viii/von willebrand factor complex 250 [iu] in 5 ml - alphanate, (antihemophilic factor/von willebrand factor complex [human]), is indicated for: - control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with factor viii (fviii) deficiency due to hemophilia a. - surgical and/or invasive procedures in adult and pediatric patients with von willebrand disease (vwd) in whom desmopressin (ddavp) is either ineffective or contraindicated.  it is not indicated for patients with severe vwd (type 3) undergoing major surgery. alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components [see adverse reactions (6) ]. pregnancy category c.  animal reproduction studies have not been conducted with alphanate.  it is also not known whether alphanate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.  alphanate should be given to a pregnant woman only if clearly needed.   no human o

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

dksh malaysia sdn. bhd. - human coagulation factor viii -

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

dksh malaysia sdn. bhd. - human coagulation factor viii -

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

dksh malaysia sdn. bhd. - human coagulation factor viii -

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human blood coagulation factor viii - injection, powder, for solution - 250 iu/vial - human blood coagulation factor viii 250 iu/vial

New Zealand - English - Medsafe (Medicines Safety Authority)

octapharma new zealand ltd - factor viii, human 250 [iu] (as human plasma coagulation factor viii. less than or equal to 5.5 mg total protein.);  ;   - powder for injection - 250 iu - active: factor viii, human 250 [iu] (as human plasma coagulation factor viii. less than or equal to 5.5 mg total protein.)     excipient: calcium chloride dihydrate fibrinogen glycine polysorbate 80 sodium chloride sodium citrate dihydrate tributyl phosphate water for injection - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). this preparation does not contain von willebrand factor in pharmacologically effective quantities and is therefore not indicated in von willebrand's disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - factor viii, human recombinant - powder and solvent for solution for injection - 1000 iu international unit(s) - blood coagulation factors; coagulation factor viii - antihaemorrhagics: blood coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). this product does not contain von willebrand factor and is therefore not indicated in von willebrand’s disease

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - factor viii, human recombinant - powder and solvent for solution for injection - 500 iu international unit(s) - blood coagulation factors; coagulation factor viii - antihaemorrhagics: blood coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). this product does not contain von willebrand factor and is therefore not indicated in von willebrand’s disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - factor viii, human recombinant - powder and solvent for solution for injection - 250 iu international unit(s) - blood coagulation factors; coagulation factor viii - antihaemorrhagics: blood coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). this product does not contain von willebrand factor and is therefore not indicated in von willebrand’s disease.