Anpheros Search · Treatment

Eptacog alfa (activated)

Also known as: NovoSeven

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In short

In the European Union, NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX greater than 5 Bethesda units, or in those expected to have a high anamnestic response to factor-VIII or factor-IX administration. It is also indicated in the European Union for patients with acquired haemophilia, patients with congenital factor-VII deficiency, and patients with Glanzmann's thrombasthenia who have antibodies to platelet glycoprotein IIb-IIIa and or human leucocyte antigens, and with past or present refractoriness to platelet transfusions. Additionally, it is indicated in the European Union for patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.

Source: European Medicines Agency (EMA), NovoSeven — EPAR, 27/02/2023. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

EMA
EMEA/H/C/000074

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) NovoSeven

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.

Source: European Medicines Agency (EMA), NovoSeven — EPAR, 27/02/2023. © European Medicines Agency.

Document date: 27/02/2023 · Official document →

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Questions

What is Eptacog alfa (activated) approved for in the European Union?

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. (Source: European Medicines Agency (EMA), NovoSeven — EPAR, 27/02/2023. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), NovoSeven — EPAR, 27/02/2023. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →