Singapore - English - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - eptacog alfa (activated)/rfviia - injection, powder, for solution - 1mg - eptacog alfa (activated)/rfviia 1mg

Singapore - English - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - eptacog alfa (activated)/rfviia - injection, powder, for solution - 2mg - eptacog alfa (activated)/rfviia 2mg

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

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. 

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

50,000units - eptacog alfa activated - powder and solvent for solution for injection - 50000unit

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

100,000units - eptacog alfa activated - powder and solvent for solution for injection - 100000unit

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

250,000units - eptacog alfa activated - powder and solvent for solution for injection - 250000unit

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

400,000units - eptacog alfa activated - powder and solvent for solution for injection - 400000unit