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 - human normal immunoglobulin - solution for injection - 200 milligram(s)/millilitre - immunoglobulins, normal human, for extravascular adm.

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - octocog alfa - powder and solvent for solution for injection - octocog alfa 25 iu/ml - antihemorrhagics

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - octocog alfa - powder and solvent for solution for injection - octocog alfa 500 iu - antihemorrhagics

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - octocog alfa - powder and solvent for solution for injection - octocog alfa 1000 iu - antihemorrhagics

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 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

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

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

baxalta uk ltd - not applicable