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NovoSeven (eptacog alfa (activated))

Region

🇪🇺 EU

Active substance

eptacog alfa (activated)

Company

Novo Nordisk A/S

Status

Authorised

Therapeutic area

Hemophilia B; Thrombasthenia; Factor VII Deficiency; Hemophilia A

EU approval

Fri 23 Feb 1996

Application

EMEA/H/C/000074

ATC

B02BD08

Official record

www.ema.europa.eu

Indication

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 HemAryo Application withdrawn · UGA Biopharma

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.