Anpheros Search · Treatment

Eptacog beta (activated)

Also known as: Cevenfacta

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In short

In the European Union, eptacog beta (activated) is indicated in adults and adolescents aged 12 years and older for the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures. This indication applies to patients with congenital haemophilia who have high-responding inhibitors to coagulation factors VIII or IX, as well as those with low titre inhibitors who are expected to have a high anamnestic response or to be refractory to increased dosing of these factors.

Source: European Medicines Agency (EMA), Cevenfacta — EPAR, 29/11/2022. © 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/005655

Official indications

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

EMA (EU) Cevenfacta

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 <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.

Source: European Medicines Agency (EMA), Cevenfacta — EPAR, 29/11/2022. © European Medicines Agency.

Document date: 29/11/2022 · Official document →

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External resources

Questions

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

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 <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX. (Source: European Medicines Agency (EMA), Cevenfacta — EPAR, 29/11/2022. © 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), Cevenfacta — EPAR, 29/11/2022. © European Medicines Agency.

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