Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human plasma coagulation factor ii; human plasma coagulation factor vii; human plasma coagulation factor ix; human plasma coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 500 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - human plasma coagulation factor ii, human plasma coagulation factor vii, human plasma coagulation factor ix, human plasma coagulation factor x, protein c, protein s - pdr+solv for soln for inf - 500 international unit - blood coagulation factors

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c - powder and solvent for solution for injection - 600 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination - antihemorrhagics, coagulation factors ix, ii, vii and x in combination - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin k antagonists or in case of overdose with vitamin k antagonists, when rapid correction of the deficiency is required. treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin k-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - factor ii, prothrombin, factor ix, human, factor x, factor vii - powder and solvent for solution for injection - factor ii (prothrombin) 24-45 iu/mg factor ix, human 30 iu/mg factor x, human 30 iu/mg factor vii, human 25 iu/mg - antihemorrhagics

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - factor viii, inhibitor bypassing, fraction - powder and solvent for solution for infusion - factor viii inhibitor bypassing fraction 25 u/ml - antihemorrhagics

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; human protein c - powder and solvent for solution for injection - coagulation factor ix, ii, vii and x in combination

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - nonacog alfa - injection, powder, for solution - 1000iu/vial(275iu/ml) - nonacog alfa 1000iu/vial(275iu/ml)

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - nonacog alfa - injection, powder, for solution - 2000iu/vial(550iu/ml) - nonacog alfa 2000iu/vial(550iu/ml)

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - nonacog alfa - injection, powder, for solution - 250iu/vial (69iu/ml) - nonacog alfa 250iu/vial (69iu/ml)

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - nonacog alfa - injection, powder, for solution - 500iu/vial(138iu/ml) - nonacog alfa 500iu/vial(138iu/ml)