European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - rurioctocog alfa pegol - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia a (congenital factor viii deficiency).

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >90% gamma globulin - powder and solvent for solution for infusion - 0.5 g/30 m gram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration - primary immunodeficiency syndromes (pid): congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiencies severe combined immunodeficiencies wiskott aldrich syndrome myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections children with congenital aids and recurrent infections

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.

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - susoctocog alfa - hemophilia a - antihemorrhagics - treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to factor viii. obizur is indicated in adults.

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - vonicog alfa - von willebrand diseases - antihemorrhagics - veyvondi is indicated in adults (age 18 and older) with von willebrand disease (vwd), when desmopressin (ddavp) treatment alone is ineffective or not indicated for the- treatment of haemorrhage and surgical bleeding- prevention of surgical bleeding.veyvondi should not be used in the treatment of haemophilia a.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - feiba - powder and solvent for solution for infusion - 25 unit(s)/millilitre - blood coagulation factors; factor viii inhibitor bypassing activity - coagulation factors - it is used for: treatment of bleeding in hemophilia a patients with inhibitors; treatment of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available (see section 5.1); treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor viii; prophylaxis of bleeding in hemophilia a patients with inhibitors who have experienced a significant bleed or are at high risk of significant bleeding

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - feiba - powder and solvent for solution for infusion - 50 unit(s)/millilitre - blood coagulation factors; factor viii inhibitor bypassing activity - blood coagulation factors - it is used for: treatment of bleeding in hemophilia a patients with inhibitors; treatment of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available (see section 5.1); treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor viii; prophylaxis of bleeding in hemophilia a patients with inhibitors who have experienced a significant bleed or are at high risk of significant bleeding

Malta - English - Malta 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 - Malta 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

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