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 - antithrombin iii - powder and solvent for solution for infusion or injection - antithrombin iii 50 iu - antithrombotic agents

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - antithrombin iii - powder and solvent for solution for infusion or injection - antithrombin iii 50 iu/ml - antithrombotic agents

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 - nonacog gamma - hemophilia b - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

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).

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

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.,

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: getz pharma (phils.), inc.; distributor: n/a - simvastatin - film-coated tablet - 40mg

Philippines - English - FDA (Food And Drug Administration)

getz pharma (phils.) inc. - simvastatin - film-coated tablet - 20mg