European Union - English - EMA (European Medicines Agency)

octapharma ab - simoctocog alfa - hemophilia a - blood coagulation factors - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).nuwiq can be used for all age groups.

European Union - English - EMA (European Medicines Agency)

octapharma ab - simoctocog alfa - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).vihuma can be used for all age groups.

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

octapharma usa inc - simoctocog alfa (unii: u50vww6xh6) (simoctocog alfa - unii:u50vww6xh6) - simoctocog alfa 4000 [iu] in 2.5 ml - nuwiq is a recombinant antihemophilic factor [blood coagulation factor viii (factor viii)] indicated in adults and children with hemophilia a for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes nuwiq is not indicated for the treatment of von willebrand disease. nuwiq is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components. risk summary there are no data with nuwiq use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with nuwiq. it is not known whether nuwiq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. nuwiq should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnan

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

octapharma ltd - simoctocog alfa - powder and solvent for solution for injection - 250unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

octapharma ltd - simoctocog alfa - powder and solvent for solution for injection - 1000unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

octapharma ltd - simoctocog alfa - powder and solvent for solution for injection - 2000unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

octapharma ltd - simoctocog alfa - powder and solvent for solution for injection - 500unit

Canada - English - Health Canada

octapharma pharmazeutika produktionsges m b h - simoctocog alfa; water - kit - 250unit; 2.5ml - simoctocog alfa 250unit; water 2.5ml - hemostatics

Canada - English - Health Canada

octapharma pharmazeutika produktionsges m b h - simoctocog alfa; water - kit - 500unit; 2.5ml - simoctocog alfa 500unit; water 2.5ml - hemostatics

Canada - English - Health Canada

octapharma pharmazeutika produktionsges m b h - simoctocog alfa; water - kit - 1000unit; 2.5ml - simoctocog alfa 1000unit; water 2.5ml - hemostatics