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

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.

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.

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

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - powder and solvent for solution for injection - human coagulation factor x 30 iu/ml human coagulation factor ix 30 iu/ml human coagulation factor vii 25 iu/ml human coagulation factor ii 22.5-42.5 iu/ml - 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

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

baxalta uk ltd - nonacog gamma - powder and solvent for solution for injection - 250unit

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

baxalta uk ltd - nonacog gamma - powder and solvent for solution for injection - 500unit