European Union - English - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - antihemorrhagics - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i.e. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu

Israel - English - Ministry of Health

novo nordisk ltd., israel - eptacog alfa (activated) - powder for solution for injection - eptacog alfa (activated) 1 mg/vial - eptacog alfa (activated) - eptacog alfa (activated) - novoseven ® rt is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: •in patients with congenital haemophilia with inhibitors to coagulation factors viii or ix > 5 bethesda units (bu) •in patients with congenital haemophilia who are expected to have a high anamnestic response to factor viii or factor ix administration •in patients with acquired haemophilia •in patients with congenital fvii deficiency •in patients with glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.severe postpartum haemorrhagenovoseven rt is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis

Israel - English - Ministry of Health

novo nordisk ltd., israel - eptacog alfa (activated) - powder for solution for injection - eptacog alfa (activated) 2 mg/vial - eptacog alfa (activated) - eptacog alfa (activated) - novoseven ® rt is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: •in patients with congenital haemophilia with inhibitors to coagulation factors viii or ix > 5 bethesda units (bu) •in patients with congenital haemophilia who are expected to have a high anamnestic response to factor viii or factor ix administration •in patients with acquired haemophilia •in patients with congenital fvii deficiency •in patients with glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.severe postpartum haemorrhagenovoseven rt is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis

Israel - English - Ministry of Health

novo nordisk ltd., israel - eptacog alfa (activated) - powder for solution for injection - eptacog alfa (activated) 5 mg/vial - eptacog alfa (activated) - eptacog alfa (activated) - novoseven ® rt is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: •in patients with congenital haemophilia with inhibitors to coagulation factors viii or ix > 5 bethesda units (bu) •in patients with congenital haemophilia who are expected to have a high anamnestic response to factor viii or factor ix administration •in patients with acquired haemophilia •in patients with congenital fvii deficiency •in patients with glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.severe postpartum haemorrhagenovoseven rt is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - eptacog alfa (activated) 1mg - powder for injection with diluent - 1 mg - active: eptacog alfa (activated) 1mg excipient: calcium chloride dihydrate glycylglycine mannitol methionine nitrogen polysorbate 80 sodium chloride sucrose histidine water for injection - indicated for the control of bleeding and surgical prophylaxis in patients: · with inhibitors to coagulation factors viii or ix · with congenital fvii deficiency · with glanzmann's thrombasthenia, who have antibodies to gpiib-iiia and/or hla, and with past or present refractoriness to platelet transfusions

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - eptacog alfa (activated) 2mg - powder for injection with diluent - 2 mg - active: eptacog alfa (activated) 2mg excipient: calcium chloride dihydrate glycylglycine mannitol methionine nitrogen polysorbate 80 sodium chloride sucrose histidine water for injection - indicated for the control of bleeding and surgical prophylaxis in patients: · with inhibitors to coagulation factors viii or ix · with congenital fvii deficiency · with glanzmann's thrombasthenia, who have antibodies to gpiib-iiia and/or hla, and with past or present refractoriness to platelet transfusions

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - eptacog alfa (activated) 5mg - powder for injection with diluent - 5 mg - active: eptacog alfa (activated) 5mg excipient: calcium chloride dihydrate glycylglycine mannitol methionine nitrogen polysorbate 80 sodium chloride sucrose histidine water for injection - indicated for the control of bleeding and surgical prophylaxis in patients: · with inhibitors to coagulation factors viii or ix · with congenital fvii deficiency · with glanzmann's thrombasthenia, who have antibodies to gpiib-iiia and/or hla, and with past or present refractoriness to platelet transfusions

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - eptacog alfa (activated) 8mg;   - powder for injection with diluent - 8 mg - active: eptacog alfa (activated) 8mg   excipient: calcium chloride dihydrate glycylglycine mannitol methionine nitrogen polysorbate 80 sodium chloride sucrose histidine water for injection - indicated for the control of bleeding and surgical prophylaxis in patients: · with inhibitors to coagulation factors viii or ix · with congenital fvii deficiency · with glanzmann's thrombasthenia, who have antibodies to gpiib-iiia and/or hla, and with past or present refractoriness to platelet transfusions

European Union - English - EMA (European Medicines Agency)

novo nordisk a/s - eptacog alfa (activated) - hemophilia b; thrombasthenia; factor vii deficiency; hemophilia a - antihemorrhagics - novoseven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with inhibitors to coagulation factors viii or ix > 5 bethesda units (bu);in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-viii or factor-ix administration;in patients with acquired haemophilia;in patients with congenital factor-vii deficiency;in patients with glanzmann's thrombasthenia with antibodies to platelet glycoprotein (gp) iib-iiia and / or human leucocyte antigens (hla), and with past or present refractoriness to platelet transfusions.in patients with glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available. 

Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - histidine, quantity: 12.57 mg - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium hydroxide - novoseven rt is indicated for the control of bleeding and surgical prophylaxis in patients: with inhibitors to coagulation factors viii or ix; with congenital fvii deficiency; with glanzmann's thrombasthenia, who have antibodies to gpiib-iiia and/or hla, and with past or present refractoriness to platelet transfusions.